Large-scale implementation of stroke early supported discharge: the WISE realist mixed-methods study

Implementation of stroke early supported discharge (ESD) services has been recommended in many countries' clinical guidelines, based on clinical trial evidence. This is the first observational study to investigate the effectiveness of ESD service models operating in real-world conditions, at scale. Using historical prospective data from the United Kingdom Sentinel Stroke National Audit Programme (January 1, 2016-December 31, 2016), measures of ESD effectiveness were "days to ESD" (number of days from hospital discharge to first ESD contact; n=6222), "rehabilitation intensity" (total number of treatment days/total days with ESD; n=5891), and stroke survivor outcome (modified Rankin scale at ESD discharge; n=6222). ESD service models (derived from Sentinel Stroke National Audit Programme postacute organizational audit data) were categorized with a 17-item score, reflecting adoption of ESD consensus core components (evidence-based criteria). Multilevel modeling analysis was undertaken as patients were clustered within ESD teams across the Midlands, East, and North of England (n=31). A variety of ESD service models had been adopted, as reflected by variability in the ESD consensus score. Controlling for patient characteristics and Sentinel Stroke National Audit Programme hospital score, a 1-unit increase in ESD consensus score was significantly associated with a more responsive ESD service (reduced odds of patient being seen after ≥1 day of 29% [95% CI, 1%-49%] and increased treatment intensity by 2% [95% CI, 0.3%-4%]). There was no association with stroke survivor outcome measured by the modified Rankin Scale. This study has shown that adopting defined core components of ESD is associated with providing a more responsive and intensive ESD service. This shows that adherence to evidence-based criteria is likely to result in a more effective ESD service as defined by process measures. Registration: URL: http://www.isrctn.com/; Unique identifier: ISRCTN15568163.

Stroke pathway – Evidence Base Commissioning. An Evidence Review

BackgroundStroke Early Supported Discharge (ESD) is a service innovation that facilitates discharge from hospital and delivery of specialist rehabilitation in patients’ homes. There is currently widespread implementation of ESD services in many countries, driven by robust clinical trial evidence. In England, the type of ESD service patients receive on the ground is variable, and in some regions, ESD is still not offered at all. This protocol presents a study designed to investigate the mechanisms and outcomes of implementing ESD at scale in real-world conditions. This will help to establish which models of ESD are most effective and in what context.MethodsA realist evaluation approach composed of two interlinking work packages will be adopted to investigate how and why ESD works, for whom and in what circumstances. Work package 1 (WP1) will begin with a rapid evidence synthesis to formulate preliminary realist hypotheses. Quantitative analyses of historical prospective Sentinel Stroke National Audit Programme (SSNAP) data will be performed to evaluate service outcomes based on the degree to which evidence-based ESD has been implemented. Work package 2 (WP2) will involve the qualitative investigation of purposively selected case study sites featuring in WP1 and covering different regions in England. The perspectives of clinicians, managers, commissioners, and service users will be explored qualitatively. Cost implications of ESD models will be examined using a cost-consequence analysis. Cross-case comparisons and triangulation of the data sources from both work packages will be performed to test, revise, and refine initial programme theories and address research aims.DiscussionThis study will investigate whether and how current large-scale implementation of ESD is achieving the outcomes suggested by the evidence base. The theory-driven evaluation approach will highlight key mechanisms and contextual conditions necessary to optimise outcomes and allow us to draw transferable lessons to inform the effective implementation and sustainability of ESD in clinical practice. In addition, the methodological framework will progress the theoretical understanding of implementation and evaluation of complex rehabilitation interventions in stroke care.Trial registrationISRCTN: 15568163, registration date: 26 October 2018.

Bisphosphonates are contraindicated in patients with stage 4+ chronic kidney disease. However, they are widely used to prevent fragility fractures in stage 3 chronic kidney disease, despite a lack of good-quality data on their effects. The aims of each work package were as follows. Work package 1: to study the relationship between bisphosphonate use and chronic kidney disease progression. Work package 2: to study the association between using bisphosphonates and fracture risk. Work package 3: to determine the risks of hypocalcaemia, hypophosphataemia, acute kidney injury and upper gastrointestinal events associated with using bisphosphonates. Work package 4: to investigate the association between using bisphosphonates and changes in bone mineral density over time. This was a new-user cohort study design with propensity score matching. Data were obtained from UK NHS primary care (Clinical Practice Research Datalink GOLD database) and linked hospital inpatient records (Hospital Episode Statistics) for work packages 1-3 and from the Danish Odense University Hospital Databases for work package 4. Patients registered in the data sources who had at least one measurement of estimated glomerular filtration rate of < 45 ml/minute/1.73 m2 were eligible. A second estimated glomerular filtration rate value of < 45 ml/minute/1.73 m2 within 1 year after the first was requested for work packages 1 and 3. Patients with no Hospital Episode Statistics linkage were excluded from work packages 1-3. Patients with < 1 year of run-in data before index estimated glomerular filtration rate and previous users of anti-osteoporosis medications were excluded from work packages 1-4. Bisphosphonate use, identified from primary care prescriptions (for work packages 1-3) or pharmacy dispensations (for work package 4), was the main exposure. Work package 1: chronic kidney disease progression, defined as stage worsening or starting renal replacement. Work package 2: hip fracture. Work package 3: acute kidney injury, hypocalcaemia and hypophosphataemia identified from Hospital Episode Statistics, and gastrointestinal events identified from Clinical Practice Research Datalink or Hospital Episode Statistics. Work package 4: annualised femoral neck bone mineral density percentage change. Bisphosphonate use was associated with an excess risk of chronic kidney disease progression (subdistribution hazard ratio 1.12, 95% confidence interval 1.02 to 1.24) in work package 1, but did not increase the probability of other safety outcomes in work package 3. The results from work package 2 suggested that bisphosphonate use increased fracture risk (hazard ratio 1.25, 95% confidence interval 1.13 to 1.39) for hip fractures, but sensitivity analyses suggested that this was related to unresolved confounding. Conversely, work package 4 suggested that bisphosphonates improved bone mineral density, with an average 2.65% (95% confidence interval 1.32% to 3.99%) greater gain in femoral neck bone mineral density per year in bisphosphonate users than in matched non-users. Confounding by indication was a concern for the clinical effectiveness (i.e. work package 2) data. Bias analyses suggested that these findings were due to inappropriate adjustment for pre-treatment risk. work packages 3 and 4 were based on small numbers of events and participants, respectively. Bisphosphonates were associated with a 12% excess risk of chronic kidney disease progression in participants with stage 3B+ chronic kidney disease. No other safety concerns were identified. Bisphosphonate therapy increased bone mineral density, but the research team failed to demonstrate antifracture effectiveness. Randomised controlled trial data are needed to demonstrate antifracture efficacy in patients with stage 3B+ chronic kidney disease. More safety analyses are needed to characterise the renal toxicity of bisphosphonates in stage 3A chronic kidney disease, possibly using observational data. This study is registered as EUPAS10029. 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. 25, No. 17. See the NIHR Journals Library website for further project information. The project was also supported by the National Institute for Health Research Biomedical Research Centre, Oxford.

Objectives: To understand why most stroke patients receive little therapy. We investigated the factors associated with the amount of stroke therapy delivered. Methods: Data regarding adults admitted to hospital with stroke for at least 72 hours (July 2013–July 2015) were extracted from the UK’s Sentinel Stroke National Audit Programme. Descriptive statistics and multilevel mixed effects regression models explored the factors that influenced the amount of therapy received while adjusting for confounding. Results: Of the 94,905 patients in the study cohort (mean age: 76 (SD: 13.2) years, 78% had a mild or moderate severity stroke. In all, 92% required physiotherapy, 87% required occupational therapy, 57% required speech therapy but only 5% were considered to need psychology. The average amount of therapy ranged from 2 minutes (psychology) to 14 minutes (physiotherapy) per day of inpatient stay. Unmodifiable characteristics (such as stroke severity) dominated the variation in the amount of therapy. However important, modifiable organizational factors were the day and time of admission, type of stroke team, timely therapy assessments, therapy and nursing staffing levels (qualified and support staff), and presence of weekend or early supported discharge services. Conclusion: The amount of stroke therapy is associated with unmodifiable patient-related characteristics and modifiable organizational factors in that more therapy was associated with higher therapy and nurse staffing levels, specialist stroke rehabilitation services, timely therapy assessments, and the presence of weekend and early discharge services.

Background All NHS providers collect data on patient experience, although there is limited evidence about what to measure or how to collect and use data to improve services. We studied inpatient mental health services, as these are important, costly and often unpopular services within which serious incidents occur. Aims To identify which approaches to collecting and using patient experience data are most useful for supporting improvements in inpatient mental health care. Design The study comprised five work packages: a systematic review to identify evidence-based patient experience themes relevant to inpatient mental health care (work package 1); a survey of patient experience leads in NHS mental health trusts in England to describe current approaches to collecting and using patient experience data in inpatient mental health services, and to populate the sampling frame for work package 3 (work package 2); in-depth case studies at sites selected using the work package 2 findings, analysed using a realist approach (work package 3); a consensus conference to agree on recommendations about best practice (work package 4); and health economic modelling to estimate resource requirements and potential benefits arising from the adoption of best practice (work package 5). Using a realist methodology, we analysed and presented our findings using a framework based on four stages of the patient experience data pathway, for which we coined the term CRAICh (collecting and giving, receiving and listening, analysing, and quality improvement and change). The project was supported by a patient and public involvement team that contributed to work package 1 and the development of programme theories (work package 3). Two employed survivor researchers worked on work packages 2, 3 and 4. Setting The study was conducted in 57 NHS providers of inpatient mental health care in England. Participants In work package 2, 47 NHS patient experience leads took part and, in work package 3, 62 service users, 19 carers and 101 NHS staff participated, across six trusts. Forty-four individuals attended the work package 4 consensus conference. Results The patient experience feedback cycle was rarely completed and, even when improvements were implemented, these tended to be environmental rather than cultural. There were few examples of triangulation with patient safety or outcomes data. We identified 18 rules for best practice in collecting and using inpatient mental health experience data, and 154 realist context–mechanism–outcome configurations that underpin and explain these. Limitations The study was cross-sectional in design and we relied on examples of historical service improvement. Our health economic models (in work package 5) were therefore limited in the estimation and modelling of prospective benefits associated with the collection and use of patient experience data. Conclusions Patient experience work is insufficiently embedded in most mental health trusts. More attention to analysis and interpretation of patient experience data is needed, particularly to ways of triangulating these with outcomes and safety data. Future work Further evaluative research is needed to develop and evaluate a locally adapted intervention based on the 18 rules for best practice. Study registration The systematic review (work package 1) is registered as PROSPERO CRD42016033556. Funding This 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. 21. See the NIHR Journals Library website for further project information.

Case-finding and improving patient outcomes for chronic obstructive pulmonary disease in primary care: the BLISS research programme including cluster RCT

Background In 2013, 70% of people who were homeless on admission to hospital were discharged back to the street without having their care and support needs addressed. In response, the UK government provided funding for 52 new specialist homeless hospital discharge schemes. This study employed RAMESES II (Realist And Meta-narrative Evidence Syntheses: Evolving Standards) guidelines between September 2015 and 2019 to undertake a realist evaluation to establish what worked, for whom, under what circumstances and why. It was hypothesised that delivering outcomes linked to consistently safe, timely care transfers for homeless patients would depend on hospital discharge schemes implementing a series of high-impact changes (resource mechanisms). These changes encompassed multidisciplinary discharge co-ordination (delivered through clinically led homeless teams) and ‘step-down’ intermediate care. These facilitated time-limited care and support and alternative pathways out of hospital for people who could not go straight home. Methods The realist hypothesis was tested empirically and refined through three work packages. Work package 1 generated seven qualitative case studies, comparing sites with different types of specialist homeless hospital discharge schemes (n = 5) and those with no specialist discharge scheme (standard care) (n = 2). Methods of data collection included interviews with 77 practitioners and stakeholders and 70 people who were homeless on admission to hospital. A ‘data linkage’ process (work package 2) and an economic evaluation (work package 3) were also undertaken. The data linkage process resulted in data being collected on &gt; 3882 patients from 17 discharge schemes across England. The study involved people with lived experience of homelessness in all stages. Results There was strong evidence to support our realist hypothesis. Specialist homeless hospital discharge schemes employing multidisciplinary discharge co-ordination and ‘step-down’ intermediate care were more effective and cost-effective than standard care. Specialist care was shown to reduce delayed transfers of care. Accident and emergency visits were also 18% lower among homeless patients discharged at a site with a step-down service than at those without. However, there was an impact on the effectiveness of the schemes when they were underfunded or when there was a shortage of permanent supportive housing and longer-term care and support. In these contexts, it remained (tacitly) accepted practice (across both standard and specialist care sites) to discharge homeless patients to the streets, rather than delay their transfer. We found little evidence that discharge schemes fired a change in reasoning with regard to the cultural distance that positions ‘homeless patients’ as somehow less vulnerable than other groups of patients. We refined our hypothesis to reflect that high-impact changes need to be underpinned by robust adult safeguarding. Strengths and limitations To our knowledge, this is the largest study of the outcomes of homeless patients discharged from hospital in the UK. Owing to issues with the comparator group, the effectiveness analysis undertaken for the data linkage was limited to comparisons of different types of specialist discharge scheme (rather than specialist vs. standard care). Future work There is a need to consider approaches that align with those for value or alliance-based commissioning where the evaluative gaze is shifted from discrete interventions to understanding how the system is working as a whole to deliver outcomes for a defined patient population. Funding This 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. 9, No. 17. See the NIHR Journals Library website for further project information.

Background For people in mental health crisis, acute day units provide daily structured sessions and peer support in non-residential settings as an alternative to crisis resolution teams. Objectives To investigate the provision, effectiveness, intervention acceptability and re-admission rates of acute day units. Design Work package 1 – mapping and national questionnaire survey of acute day units. Work package 2.1 – cohort study comparing outcomes during a 6-month period between acute day unit and crisis resolution team participants. Work package 2.2 – qualitative interviews with staff and service users of acute day units. Work package 3 – a cohort study within the Mental Health Minimum Data Set exploring re-admissions to acute care over 6 months. A patient and public involvement group supported the study throughout. Setting and participants Work package 1 – all non-residential acute day units (NHS and voluntary sector) in England. Work packages 2.1 and 2.2 – four NHS trusts with staff, service users and carers in acute day units and crisis resolution teams. Work package 3 – all individuals using mental health NHS trusts in England. Results Work package 1 – we identified 27 acute day units in 17 out of 58 trusts. Acute day units are typically available on weekdays from 10 a.m. to 4 p.m., providing a wide range of interventions and a multidisciplinary team, including clinicians, and having an average attendance of 5 weeks. Work package 2.1 – we recruited 744 participants (acute day units, n = 431; crisis resolution teams, n = 312). In the primary analysis, 21% of acute day unit participants (vs. 23% of crisis resolution team participants) were re-admitted to acute mental health services over 6 months. There was no statistically significant difference in the fully adjusted model (acute day unit hazard ratio 0.78, 95% confidence interval 0.54 to 1.14; p = 0.20), with highly heterogeneous results between trusts. Acute day unit participants had higher satisfaction and well-being scores and lower depression scores than crisis resolution team participants. The health economics analysis found no difference in resource use or cost between the acute day unit and crisis resolution team groups in the fully adjusted analysis. Work package 2.2 – 36 people were interviewed (acute day unit staff, n = 12; service users, n = 21; carers, n = 3). There was an overwhelming consensus that acute day units are highly valued. Service users found the high amount of contact time and staff continuity, peer support and structure provided by acute day units particularly beneficial. Staff also valued providing continuity, building strong therapeutic relationships and providing a variety of flexible, personalised support. Work package 3 – of 231,998 individuals discharged from acute care (crisis resolution team, acute day unit or inpatient ward), 21.4% were re-admitted for acute treatment within 6 months, with women, single people, people of mixed or black ethnicity, those living in more deprived areas and those in the severe psychosis care cluster being more likely to be re-admitted. Little variation in re-admissions was explained at the trust level, or between trusts with and trusts without acute day units (adjusted odds ratio 0.96, 95% confidence interval 0.80 to 1.15). Limitations In work package 1, some of the information is likely to be incomplete as a result of trusts’ self-reporting. There may have been recruitment bias in work packages 2.1 and 2.2. Part of the health economics analysis relied on clinical Health of the Nations Outcome Scale ratings. The Mental Health Minimum Data Set did not contain a variable identifying acute day units, and some covariates had a considerable number of missing data. Conclusions Acute day units are not provided routinely in the NHS but are highly valued by staff and service users, giving better outcomes in terms of satisfaction, well-being and depression than, and no significant differences in risk of re-admission or increased costs from, crisis resolution teams. Future work should investigate wider health and care system structures and the place of acute day units within them; the development of a model of best practice for acute day units; and staff turnover and well-being (including the impacts of these on care). Funding This 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. 9, No. 18. See the NIHR Journals Library website for further project information.

Background Seven-day working in hospitals is a current priority of international health research and policy. Previous research has shown variability in delivering evidence-based clinical interventions across different times of the day and week. We aimed to identify factors influencing such variations in London hyperacute stroke units. Objectives To investigate variations in quality of acute stroke care and outcomes by day and time of admission in London hyperacute stroke units, and to identify factors influencing such variations. Design This was a prospective cohort study using anonymised patient-level data from the Sentinel Stroke National Audit Programme. Factors influencing variations in care and outcomes were studied through interview and observation data. Setting The setting was acute stroke services in London hyperacute stroke units. Participants A total of 7094 patients with a primary diagnosis of stroke took part. We interviewed hyperacute stroke unit staff (n = 76), including doctors, nurses, therapists and administrators, and 31 patients and carers. We also conducted non-participant observations of delivery of care at different times of the day and week (n = 45, ≈102 hours). Intervention Hub-and-spoke model for care of suspected acute stroke patients in London with performance standards was designed to deliver uniform access to high-quality hyperacute stroke unit care across the week. Main outcome measures Indicators of quality of acute stroke care, mortality at 3 days after admission, disability at the end of the inpatient spell and length of stay. Data sources Sentinel Stroke National Audit Programme data for all patients in London hyperacute stroke units with a primary diagnosis of stroke between 1 January and 31 December 2014, and nurse staffing data for all eight London hyperacute stroke units for the same period. Results We found no variation in quality of care by day and time of admission across the week in terms of stroke nursing assessment, brain scanning and thrombolysis in London hyperacute stroke units, nor in 3-day mortality nor disability at hospital discharge. Other quality-of-care measures significantly varied by day and time of admission. Quality of care was better if the nurse in charge was at a higher band and/or there were more nurses on duty. Staff deliver ‘front-door’ interventions consistently by taking on additional responsibilities out of hours, creating continuities between day and night, building trusting relationships and prioritising ‘front-door’ interventions. Limitations We were unable to measure long-term outcomes as our request to the Sentinel Stroke National Audit Programme, the Healthcare Quality Improvement Partnership and NHS Digital for Sentinel Stroke National Audit Programme data linked with patient mortality status was not fulfilled. Conclusions Organisational factors influence 24 hours a day, 7 days a week (24/7), provision of stroke care, creating temporal patterns of provision reflected in patient outcomes, including mortality, length of stay and functional independence. Future work Further research would help to explore 24/7 stroke systems in other contexts. We need a clearer understanding of variations by looking at absolute time intervals, rather than achievement of targets. Research is needed with longer-term mortality and modified Rankin Scale data, and a more meaningful range of outcomes. Funding This 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. 34. See the NIHR Journals Library website for further project information.

BackgroundDissemination of clinical guidelines is necessary but seldom sufficient by itself to ensure the reliable uptake of evidence-based practice. There are further challenges in implementing multiple clinical guidelines and clinical practice recommendations in the pressurised environment of general practice.ObjectivesWe aimed to develop and evaluate an implementation package that could be adapted to support the uptake of a range of clinical guideline recommendations and be sustainably integrated within general practice systems and resources. Over five linked work packages, we developed ‘high-impact’ quality indicators to show where a measurable change in clinical practice can improve patient outcomes (work package 1), analysed adherence to selected indicators (work package 2), developed an adaptable implementation package (work package 3), evaluated the effects and cost-effectiveness of adapted implementation packages targeting four indicators (work package 4) and examined intervention fidelity and mechanisms of action (work package 5).Setting and participantsHealth-care professionals and patients from general practices in West Yorkshire, UK.DesignWe reviewed recommendations from existing National Institute for Health and Care Excellence clinical guidance and used a multistage consensus process, including 11 professionals and patients, to derive a set of ‘high-impact’ evidence-based indicators that could be measured using routinely collected data (work package 1). In 89 general practices that shared data, we found marked variations and scope for improvement in adherence to several indicators (work package 2). Interviews with 60 general practitioners, practice nurses and practice managers explored perceived determinants of adherence to selected indicators and suggested the feasibility of adapting an implementation package to target different indicators (work package 3). We worked with professional and patient panels to develop four adapted implementation packages. These targeted risky prescribing involving non-steroidal anti-inflammatory and antiplatelet drugs, type 2 diabetes control, blood pressure control and anticoagulation for atrial fibrillation. The implementation packages embedded behaviour change techniques within audit and feedback, educational outreach and (for risky prescribing) computerised prompts. We randomised 178 practices to implementation packages targeting either diabetes control or risky prescribing (trial 1), or blood pressure control or anticoagulation (trial 2), or to a further control (non-intervention) group, and undertook economic modelling (work package 4). In trials 1 and 2, practices randomised to the implementation package for one indicator acted as control practices for the other package, and vice versa. A parallel process evaluation included a further eight practices (work package 5).Main outcome measuresTrial primary end points at 11 months comprised achievement of all recommended levels of glycated haemoglobin, blood pressure and cholesterol; risky prescribing levels; achievement of recommended blood pressure; and anticoagulation prescribing.ResultsWe recruited 178 (73%) out of 243 eligible general practices. We randomised 80 practices to trial 1 (40 per arm) and 64 to trial 2 (32 per arm), with 34 non-intervention controls. The risky prescribing implementation package reduced risky prescribing (odds ratio 0.82, 97.5% confidence interval 0.67 to 0.99;p = 0.017) with an incremental cost-effectiveness ratio of £2337 per quality-adjusted life-year. The other three packages had no effect on primary end points. The process evaluation suggested that trial outcomes were influenced by losses in fidelity throughout intervention delivery and enactment, and by the nature of the targeted clinical and patient behaviours.LimitationsOur programme was conducted in one geographical area; however, practice and patient population characteristics are otherwise likely to be sufficiently diverse and typical to enhance generalisability to the UK. We used an ‘opt-out’ approach to recruit general practices to the randomised trials. Subsequently, our trial practices may have engaged with the implementation package less than if they had actively volunteered. However, this approach increases confidence in the wider applicability of trial findings as it replicates guideline implementation activities under standard conditions.ConclusionsThis pragmatic, rigorous evaluation indicates the value of an implementation package targeting risky prescribing. In broad terms, an adapted ‘one-size-fits-all’ approach did not consistently work, with no improvement for other targeted indicators.Future workThere are challenges in designing ‘one-size-fits-all’ implementation strategies that are sufficiently robust to bring about change in the face of difficult clinical contexts and fidelity losses. We recommend maximising feasibility and ‘stress testing’ prior to rolling out interventions within a definitive evaluation. Our programme has led on to other work, adapting audit and feedback for other priorities and evaluating different ways of delivering feedback to improve patient care.Trial registrationCurrent Controlled Trials ISRCTN91989345.FundingThis project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full inProgramme Grants for Applied Research; Vol. 8, No. 4. See the NIHR Journals Library website for further project information.

Background Bias in the publication and reporting of research findings (referred to as publication and related bias here) poses a major threat in evidence synthesis and evidence-based decision-making. Although this bias has been well documented in clinical research, little is known about its occurrence and magnitude in health services and delivery research. Objectives To obtain empirical evidence on publication and related bias in quantitative health services and delivery research; to examine current practice in detecting/mitigating this bias in health services and delivery research systematic reviews; and to explore stakeholders’ perception and experiences concerning such bias. Methods The project included five distinct but interrelated work packages. Work package 1 was a systematic review of empirical and methodological studies. Work package 2 involved a survey (meta-epidemiological study) of randomly selected systematic reviews of health services and delivery research topics (n = 200) to evaluate current practice in the assessment of publication and outcome reporting bias during evidence synthesis. Work package 3 included four case studies to explore the applicability of statistical methods for detecting such bias in health services and delivery research. In work package 4 we followed up four cohorts of health services and delivery research studies (total n = 300) to ascertain their publication status, and examined whether publication status was associated with statistical significance or perceived ‘positivity’ of study findings. Work package 5 involved key informant interviews with diverse health services and delivery research stakeholders (n = 24), and a focus group discussion with patient and service user representatives (n = 8). Results We identified only four studies that set out to investigate publication and related bias in health services and delivery research in work package 1. Three of these studies focused on health informatics research and one concerned health economics. All four studies reported evidence of the existence of this bias, but had methodological weaknesses. We also identified three health services and delivery research systematic reviews in which findings were compared between published and grey/unpublished literature. These reviews found that the quality and volume of evidence and effect estimates sometimes differed significantly between published and unpublished literature. Work package 2 showed low prevalence of considering/assessing publication (43%) and outcome reporting (17%) bias in health services and delivery research systematic reviews. The prevalence was lower among reviews of associations than among reviews of interventions. The case studies in work package 3 highlighted limitations in current methods for detecting these biases due to heterogeneity and potential confounders. Follow-up of health services and delivery research cohorts in work package 4 showed positive association between publication status and having statistically significant or positive findings. Diverse views concerning publication and related bias and insights into how features of health services and delivery research might influence its occurrence were uncovered through the interviews with health services and delivery research stakeholders and focus group discussion conducted in work package 5. Conclusions This study provided prima facie evidence on publication and related bias in quantitative health services and delivery research. This bias does appear to exist, but its prevalence and impact may vary depending on study characteristics, such as study design, and motivation for conducting the evaluation. Emphasis on methodological novelty and focus beyond summative assessments may mitigate/lessen the risk of such bias in health services and delivery research. Methodological and epistemological diversity in health services and delivery research and changing landscape in research publication need to be considered when interpreting the evidence. Collection of further empirical evidence and exploration of optimal health services and delivery research practice are required. Study registration This study is registered as PROSPERO CRD42016052333 and CRD42016052366. Funding This 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. 33. See the NIHR Journals Library website for further project information.

BackgroundStroke early supported discharge (ESD) involves the co-ordinated transfer of care from hospital to home. The quality of communication processes between professionals delivering ESD and external stakeholders may have a role to play in streamlining this process. We explored how communication and information exchange were achieved and influenced the hospital-to-home transition and the delivery quality of ESD, from healthcare professionals’ perspectives.MethodsSix ESD case study sites in England were purposively selected. Under a realist approach, we conducted interviews and focus groups with 117 staff members, including a cross-section of the multidisciplinary team, service managers and commissioners.ResultsGreat variation was observed between services in the type of communication processes they employed and how organised these efforts were. Effective communication between ESD team members and external stakeholders was identified as a key mechanism driving the development of collaborative and trusting relationships and promoting coordinated care transitions. Cross-boundary working arrangements with inpatient services helped clarify the role and remit of ESD, contributing to timely hospital discharge and response from ESD teams. Staff perceived honest and individualised information provision as key to effectively prepare stroke survivors and families for care transitions and promote rehabilitation engagement. In designing and implementing ESD, early stakeholder involvement ensured the services’ fit in the local pathway and laid the foundations for communication and partnership working going forward.ConclusionsFindings highlighted the interdependency between services delivering ESD and local stroke care pathways. Maintaining good communication and engagement with key stakeholders may help achieve a streamlined hospital discharge process and timely delivery of ESD. ESD services should actively manage communication processes with external partners. A shared cross-service communication strategy to guide the provision of information along to continuum of stroke care is required. Findings may inform efforts towards the delivery of better coordinated stroke care pathways.

Stroke early supported discharge (ESD) involves the co-ordinated transfer of care from hospital to home. The quality of communication processes between professionals delivering ESD and external stakeholders may have a role to play in streamlining this process. We explored how communication and information exchange were achieved and influenced the hospital-to-home transition and the delivery quality of ESD, from healthcare professionals' perspectives. Six ESD case study sites in England were purposively selected. Under a realist approach, we conducted interviews and focus groups with 117 staff members, including a cross-section of the multidisciplinary team, service managers and commissioners. Great variation was observed between services in the type of communication processes they employed and how organised these efforts were. Effective communication between ESD team members and external stakeholders was identified as a key mechanism driving the development of collaborative and trusting relationships and promoting coordinated care transitions. Cross-boundary working arrangements with inpatient services helped clarify the role and remit of ESD, contributing to timely hospital discharge and response from ESD teams. Staff perceived honest and individualised information provision as key to effectively prepare stroke survivors and families for care transitions and promote rehabilitation engagement. In designing and implementing ESD, early stakeholder involvement ensured the services' fit in the local pathway and laid the foundations for communication and partnership working going forward. Findings highlighted the interdependency between services delivering ESD and local stroke care pathways. Maintaining good communication and engagement with key stakeholders may help achieve a streamlined hospital discharge process and timely delivery of ESD. ESD services should actively manage communication processes with external partners. A shared cross-service communication strategy to guide the provision of information along to continuum of stroke care is required. Findings may inform efforts towards the delivery of better coordinated stroke care pathways.

Patients after stroke conventionally receive much of their rehabilitation in hospital. Services have been developed that offer patients an early discharge from hospital with more rehabilitation at home (early supported discharge). This paper sets out a systematic review of all randomized trials of early supported discharge services that included 12 trials (1659 patients). There was a reduced odds of death or dependency equivalent to 5 fewer adverse outcomes (95% confidence interval 1-10) for every 100 patients receiving an early supported discharge service (p = 0.04). Patients receiving early supported discharge services showed an 8 day reduction (p < 0.0001) in the length of hospital stay. The greatest benefits were seen in the trials evaluating a co-ordinated multidisciplinary early supported discharge team and with patients with mild-moderate disability. The experience of a trial from Stockholm is described in order to explore the potential mechanism of action of early supported discharge services. In conclusion, an illustrative case report is set out, indicating a typical patient pathway in an early supported discharge service.