Making it easy to do the right thing in healthcare: Advancing improvement science education through accredited pan European higher education modules

Background: Numerous international policy drivers espouse the need to improve healthcare. The application of Improvement Science has the potential to restore the balance of healthcare and transform it to a more person-centred and quality improvement focussed system. However there is currently no accredited Improvement Science education offered routinely to healthcare students. This means that there are a huge number of healthcare professionals who do not have the conceptual or experiential skills to apply Improvement Science in everyday practise. Methods: This article describes how seven European Higher Education Institutions (HEIs) worked together to develop four evidence informed accredited inter-professional Improvement Science modules for under and postgraduate healthcare students. It outlines the way in which a Policy Delphi, a narrative literature review, a review of the competency and capability requirements for healthcare professionals to practise Improvement Science, and a mapping of current Improvement Science education informed the content of the modules. Results: A contemporary consensus definition of Healthcare Improvement Science was developed. The four Improvement Science modules that have been designed are outlined. A framework to evaluate the impact modules have in practise has been developed and piloted. Conclusion: The authors argue that there is a clear need to advance healthcare Improvement Science education through incorporating evidence based accredited modules into healthcare professional education. They suggest that if Improvement Science education, that incorporates work based learning, becomes a staple part of the curricula in inter-professional education then it has real promise to improve the delivery, quality and design of healthcare.Erasmus+ Life long Learning Programme

Accessibility and implementation in the UK NHS services of an effective depression relapse prevention programme:learning from mindfulness-based cognitive therapy through a mixed-methods study

Background: Depression affects as many as one in five people in their lifetime and often runs a recurrent lifetime course. Mindfulness-based cognitive therapy (MBCT) is an effective psychosocial approach that aims to help people at risk of depressive relapse to learn skills to stay well. However, there is an ‘implementation cliff’: access to those who could benefit from MBCT is variable and little is known about why that is the case, and how to promote sustainable implementation. As such, this study fills a gap in the literature about the implementation of MBCT. Objectives: To describe the existing provision of MBCT in the UK NHS, develop an understanding of the perceived costs and benefits of MBCT implementation, and explore the barriers and critical success factors for enhanced accessibility. We aimed to synthesise the evidence from multiple data sources to create an explanatory framework of the how and why of implementation, and to co-develop an implementation resource with key stakeholders. Design: A two-phase qualitative, exploratory and explanatory study, which was conceptually underpinned by the Promoting Action on Research Implementation in Health Services framework. Setting: UK NHS services. Methods: Phase 1 involved interviews with participants from 40 areas across the UK about the current provision of MBCT. Phase 2 involved 10 case studies purposively sampled with differing degrees of MBCT provision, and from each UK country. Case study methods included interviews with key stakeholders, including commissioners, managers, MBCT practitioners and teachers, and service users. Observations were conducted and key documents were also collected. Data were analysed using a modified approach to framework analysis. Emerging findings were verified through stakeholder discussions and workshops. Results: Phase 1: access to and the format of MBCT provision across the NHS remains variable. NHS services have typically adapted MBCT to their context and its integration into care pathways was also highly variable even within the same trust or health board. Participants’ accounts revealed stories of implementation journeys that were driven by committed individuals that were sometimes met by management commitment. Phase 2: a number of explanations emerged that explained successful implementation. Critically, facilitation was the central role of the MBCT implementers, who were self-designated individuals who ‘championed’ implementation, created networks and over time mobilised top-down organisational support. Our explanatory framework mapped out a prototypical implementation journey, often over many years. This involved implementers working through grassroots initiatives and over time mobilising top-down organisational support, and a continual fitting of evidence, with the MBCT intervention, contextual factors and the training/supervision of MBCT teachers. Key pivot points in the journey provided windows of challenge or opportunity. Limitations: The findings are largely based on informants’ accounts and, therefore, are at risk of the bias of self-reporting. Conclusions: Although access to MBCT across the UK is improving, it remains very patchy. This study provides an explanatory framework that helps us understand what facilitates and supports sustainable MBCT implementation. Future work: The framework and stakeholder workshops are being used to develop online implementation guidance

A randomised controlled trial and economic evaluation of intraoperative cell salvage during caesarean section in women at risk of haemorrhage: the SALVO (cell SALVage in Obstetrics) trial

Background Caesarean section is associated with blood loss and maternal morbidity. Excessive blood loss requires transfusion of donor (allogeneic) blood, which is a finite resource. Cell salvage returns blood lost during surgery to the mother. It may avoid the need for donor blood transfusion, but reliable evidence of its effects is lacking. Objectives To determine if routine use of cell salvage during caesarean section in mothers at risk of haemorrhage reduces the rates of blood transfusion and postpartum maternal morbidity, and is cost-effective, in comparison with standard practice without routine salvage use. Design Individually randomised controlled, multicentre trial with cost-effectiveness analysis. Treatment was not blinded. Setting A total of 26 UK obstetric units. Participants Out of 3054 women recruited between June 2013 and April 2016, we randomly assigned 3028 women at risk of haemorrhage to cell salvage or routine care. Randomisation was stratified using random permuted blocks of variable sizes. Of these, 1672 had emergency and 1356 had elective caesareans. We excluded women for whom cell salvage or donor blood transfusion was contraindicated. Interventions Cell salvage (intervention) versus routine care without salvage (control). In the intervention group, salvage was set up in 95.6% of the women and, of these, 50.8% had salvaged blood returned. In the control group, 3.9% had salvage deployed. Main outcome measures Primary – donor blood transfusion. Secondary – units of donor blood transfused, time to mobilisation, length of hospitalisation, mean fall in haemoglobin, fetomaternal haemorrhage (FMH) measured by Kleihauer–Betke test, and maternal fatigue. Analyses were adjusted for stratification factors and other factors that were believed to be prognostic a priori. Cost-effectiveness outcomes – costs of resources and service provision taking the UK NHS perspective. Results We analysed 1498 and 1492 participants in the intervention and control groups, respectively. Overall, the transfusion rate was 2.5% in the intervention group and 3.5% in the control group [adjusted odds ratio (OR) 0.65, 95% confidence interval (CI) 0.42 to 1.01; p = 0.056]. In a planned subgroup analysis, the transfusion rate was 3.0% in the intervention group and 4.6% in the control group among emergency caesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 1.8% in the intervention group and 2.2% in the control group among elective caesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interaction p = 0.46, suggesting that the difference in effect between subgroups was not statistically significant). Secondary outcomes did not differ between groups, except for FMH, which was higher under salvage in rhesus D (RhD)-negative women with RhD-positive babies (25.6% vs. 10.5%, adjusted OR 5.63, 95% CI 1.43 to 22.14; p = 0.013). No case of amniotic fluid embolism was observed. The additional cost of routine cell salvage during caesarean was estimated, on average, at £8110 per donor blood transfusion avoided. Conclusions The modest evidence for an effect of routine use of cell salvage during caesarean section on rates of donor blood transfusion was associated with increased FMH, which emphasises the need for adherence to guidance on anti-D prophylaxis. We are unable to comment on long-term antibody sensitisation effects. Based on the findings of this trial, cell salvage is unlikely to be considered cost-effective. Future work Research into risk of alloimmunisation among women exposed to cell salvage is needed. Trial registration Current Controlled Trials ISRCTN66118656. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 2. See the NIHR Journals Library website for further project information

The clinical effectiveness of individual behaviour change interventions to reduce risky sexual behaviour after a negative human immunodeficiency virus test in men who have sex with men: systematic and realist reviews and intervention development

Background: Men who have sex with men (MSM) experience significant inequalities in health and well-being. They are the group in the UK at the highest risk of acquiring a human immunodeficiency virus (HIV) infection. Guidance relating to both HIV infection prevention, in general, and individual-level behaviour change interventions, in particular, is very limited. Objectives: To conduct an evidence synthesis of the clinical effectiveness of behaviour change interventions to reduce risky sexual behaviour among MSM after a negative HIV infection test. To identify effective components within interventions in reducing HIV risk-related behaviours and develop a candidate intervention. To host expert events addressing the implementation and optimisation of a candidate intervention. Data sources: All major electronic databases (British Education Index, BioMed Central, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Educational Resource Index and Abstracts, Health and Medical Complete, MEDLINE, PsycARTICLES, PsycINFO, PubMed and Social Science Citation Index) were searched between January 2000 and December 2014. Review methods: A systematic review of the clinical effectiveness of individual behaviour change interventions was conducted. Interventions were examined using the behaviour change technique (BCT) taxonomy, theory coding assessment, mode of delivery and proximity to HIV infection testing. Data were summarised in narrative review and, when appropriate, meta-analysis was carried out. Supplemental analyses for the development of the candidate intervention focused on post hoc realist review method, the assessment of the sequential delivery and content of intervention components, and the social and historical context of primary studies. Expert panels reviewed the candidate intervention for issues of implementation and optimisation. Results: Overall, trials included in this review (n = 10) demonstrated that individual-level behaviour change interventions are effective in reducing key HIV infection risk-related behaviours. However, there was considerable clinical and methodological heterogeneity among the trials. Exploratory meta-analysis showed a statistically significant reduction in behaviours associated with high risk of HIV transmission (risk ratio 0.75, 95% confidence interval 0.62 to 0.91). Additional stratified analyses suggested that effectiveness may be enhanced through face-to-face contact immediately after testing, and that theory-based content and BCTs drawn from ‘goals and planning’ and ‘identity’ groups are important. All evidence collated in the review was synthesised to develop a candidate intervention. Experts highlighted overall acceptability of the intervention and outlined key ways that the candidate intervention could be optimised to enhance UK implementation. Limitations: There was a limited number of primary studies. All were from outside the UK and were subject to considerable clinical, methodological and statistical heterogeneity. The findings of the meta-analysis must therefore be treated with caution. The lack of detailed intervention manuals limited the assessment of intervention content, delivery and fidelity. Conclusions: Evidence regarding the effectiveness of behaviour change interventions suggests that they are effective in changing behaviour associated with HIV transmission. Exploratory stratified meta-analyses suggested that interventions should be delivered face to face and immediately after testing. There are uncertainties around the generalisability of these findings to the UK setting. However, UK experts found the intervention acceptable and provided ways of optimising the candidate intervention. Future work: There is a need for well-designed, UK-based trials of individual behaviour change interventions that clearly articulate intervention content and demonstrate intervention fidelity

Beyond maternal death: improving the quality of maternal care through national studies of ‘near-miss’ maternal morbidity

Knight M, Acosta C, Brocklehurst P, Cheshire A, Fitzpatrick K, Hinton L, Jokinen M, Kemp B, Kurinczuk JJ, Lewis G, Lindquist A, Locock L, Nair M, Patel N, Quigley M, Ridge D, Rivero-Arias O, Sellers S, Shah A on behalf of the UKNeS coapplicant group. Background Studies of maternal mortality have been shown to result in important improvements to women’s health. It is now recognised that in countries such as the UK, where maternal deaths are rare, the study of near-miss severe maternal morbidity provides additional information to aid disease prevention, treatment and service provision. Objectives To (1) estimate the incidence of specific near-miss morbidities; (2) assess the contribution of existing risk factors to incidence; (3) describe different interventions and their impact on outcomes and costs; (4) identify any groups in which outcomes differ; (5) investigate factors associated with maternal death; (6) compare an external confidential enquiry or a local review approach for investigating quality of care for affected women; and (7) assess the longer-term impacts. Methods Mixed quantitative and qualitative methods including primary national observational studies, database analyses, surveys and case studies overseen by a user advisory group. Setting Maternity units in all four countries of the UK. Participants Women with near-miss maternal morbidities, their partners and comparison women without severe morbidity. Main outcome measures The incidence, risk factors, management and outcomes of uterine rupture, placenta accreta, haemolysis, elevated liver enzymes and low platelets (HELLP) syndrome, severe sepsis, amniotic fluid embolism and pregnancy at advanced maternal age (≥ 48 years at completion of pregnancy); factors associated with progression from severe morbidity to death; associations between severe maternal morbidity and ethnicity and socioeconomic status; lessons for care identified by local and external review; economic evaluation of interventions for management of postpartum haemorrhage (PPH); women’s experiences of near-miss maternal morbidity; long-term outcomes; and models of maternity care commissioned through experience-led and standard approaches. Results Women and their partners reported long-term impacts of near-miss maternal morbidities on their physical and mental health. Older maternal age and caesarean delivery are associated with severe maternal morbidity in both current and future pregnancies. Antibiotic prescription for pregnant or postpartum women with suspected infection does not necessarily prevent progression to severe sepsis, which may be rapidly progressive. Delay in delivery, of up to 48 hours, may be safely undertaken in women with HELLP syndrome in whom there is no fetal compromise. Uterine compression sutures are a cost-effective second-line therapy for PPH. Medical comorbidities are associated with a fivefold increase in the odds of maternal death from direct pregnancy complications. External reviews identified more specific clinical messages for care than local reviews. Experience-led commissioning may be used as a way to commission maternity services. Limitations This programme used observational studies, some with limited sample size, and the possibility of uncontrolled confounding cannot be excluded. Conclusions Implementation of the findings of this research could prevent both future severe pregnancy complications as well as improving the outcome of pregnancy for women. One of the clearest findings relates to the population of women with other medical and mental health problems in pregnancy and their risk of severe morbidity. Further research into models of pre-pregnancy, pregnancy and postnatal care is clearly needed

Orthotic management of instability of the knee related to neuromuscular and central nervous system disorders: systematic review, qualitative study, survey and costing analysis

Background Patients who have knee instability that is associated with neuromuscular disease (NMD) and central nervous system (CNS) conditions can be treated using orthoses, such as knee–ankle–foot orthoses (KAFOs). Objectives To assess existing evidence on the effectiveness of orthoses; patient perspectives; types of orthotic devices prescribed in the UK NHS; and associated costs. Methods Qualitative study of views of orthoses users – a qualitative in-depth interview study was undertaken. Data were analysed for thematic content. A coding scheme was developed and an inductive approach was used to identify themes. Systematic review – 18 databases were searched up to November 2014: MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, Cumulative Index to Nursing and Allied Health, EMBASE, PASCAL, Scopus, Science Citation Index, BIOSIS Previews, Physiotherapy Evidence Database, Recal Legacy, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Health Technology Assessment database, Cochrane Central Register of Controlled Trials, Conference Proceedings Citation Index: Science, Health Management Consortium, ClinicalTrials.gov, International Clinical Trials Registry Platform and National Technical Information Service. Studies of adults using an orthosis for instability of the knee related to NMD or a CNS disorder were included. Data were extracted and quality was assessed by two researchers. Narrative synthesis was undertaken. Survey and costing analysis – a web survey of orthotists, physiotherapists and rehabilitation medicine physicians was undertaken. Telephone interviews with orthotists informed a costing analysis. Results Qualitative study – a total of 24 people participated. Potential for engagement in daily activities was of vital importance to patients; the extent to which their device enabled this was the yardstick by which it was measured. Patients’ prime desired outcome was a reduction in pain, falls or trips, with improved balance and stability. Effectiveness, reliability, comfort and durability were the most valued features of orthoses. Many expressed frustration with perceived deficiencies in service provision relating to appointment and administrative systems and referral pathways. Systematic review – a total of 21 studies (478 participants) were included of people who had post-polio syndrome, inclusion body myositis, were post stroke or had spinal cord injury. The studies evaluated KAFOs (mainly carbon fibre), stance control KAFO and hip KAFOs. All of the studies were at risk of bias and, in general, were poorly reported. Survey and costing analysis – in total, 238 health-care professionals responded. A range of orthoses is prescribed for knee instability that is related to NMD or CNS conditions, approximately half being custom-made. At least 50% of respondents thought that comfort and confidence in mobility were extremely important treatment outcomes. The cost of individual KAFOs was highly variable, ranging from £73 to £3553. Conclusions Various types of orthoses are used in the NHS to manage patients with NMD/CNS conditions and knee instability, both custom-made and prefabricated, of variable cost. Evidence on the effectiveness of the orthoses is limited, especially in relation to the outcomes that are important to orthoses users. Limitations The population included was broad, limiting any in-depth consideration of specific conditions. The response rate to the survey was low, and the costing analysis was based on some assumptions that may not reflect the true costs of providing KAFOs. Future work Future work should include high-quality research on the effectiveness and cost-effectiveness of orthoses; development of a core set of outcome measures; further exploration of the views and experiences of patients; and the best models of service delivery. Study registration This study is registered as PROSPERO CRD42014010180. The qualitative study is registered as Current Controlled Trials ISRCTN65240228. Funding The National Institute for Health Research Health Technology Assessment programme

Community hospitals and their services in the NHS: identifying transferable learning from international developments - scoping review, systematic review, country reports and case studies

Background: The notion of a community hospital in England is evolving from the traditional model of a local hospital staffed by general practitioners and nurses and serving mainly rural populations. Along with the diversification of models, there is a renewed policy interest in community hospitals and their potential to deliver integrated care. However, there is a need to better understand the role of different models of community hospitals within the wider health economy and an opportunity to learn from experiences of other countries to inform this potential. Objectives This study sought to (1) define the nature and scope of service provision models that fit under the umbrella term ‘community hospital’ in the UK and other high-income countries, (2) analyse evidence of their effectiveness and efficiency, (3) explore the wider role and impact of community engagement in community hospitals, (4) understand how models in other countries operate and asses their role within the wider health-care system, and (5) identify the potential for community hospitals to perform an integrative role in the delivery of health and social care. Methods A multimethod study including a scoping review of community hospital models, a linked systematic review of their effectiveness and efficiency, an analysis of experiences in Australia, Finland, Italy, Norway and Scotland, and case studies of four community hospitals in Finland, Italy and Scotland. Results The evidence reviews found that community hospitals provide a diverse range of services, spanning primary, secondary and long-term care in geographical and health system contexts. They can offer an effective and efficient alternative to acute hospitals. Patient experience was frequently reported to be better at community hospitals, and the cost-effectiveness of some models was found to be similar to that of general hospitals, although evidence was limited. Evidence from other countries showed that community hospitals provide a wide spectrum of health services that lie on a continuum between serving a ‘geographic purpose’ and having a specific population focus, mainly older people. Structures continue to evolve as countries embark on major reforms to integrate health and social care. Case studies highlighted that it is important to consider local and national contexts when looking at how to transfer models across settings, how to overcome barriers to integration beyond location and how the community should be best represented. Limitations The use of a restricted definition may have excluded some relevant community hospital models, and the small number of countries and case studies included for comparison may limit the transferability of findings for England. Although this research provides detailed insights into community hospitals in five countries, it was not in its scope to include the perspective of patients in any depth. Conclusions At a time when emphasis is being placed on integrated and community-based care, community hospitals have the potential to assume a more strategic role in health-care delivery locally, providing care closer to people’s homes. There is a need for more research into the effectiveness and cost-effectiveness of community hospitals, the role of the community and optimal staff profile(s). Funding: The National Institute for Health Research Health Services and Delivery Research programme

CHOICE: Choosing Health Options In Chronic Care Emergencies

Background Over 70% of the health-care budget in England is spent on the care of people with long-term conditions (LTCs), and a major cost component is unscheduled health care. Psychological morbidity is high in people with LTCs and is associated with a range of adverse outcomes, including increased mortality, poorer physical health outcomes, increased health costs and service utilisation. Objectives The aim of this programme of research was to examine the relationship between psychological morbidity and use of unscheduled care in people with LTCs, and to develop a psychosocial intervention that would have the potential to reduce unscheduled care use. We focused largely on emergency hospital admissions (EHAs) and attendances at emergency departments (EDs). Design A three-phase mixed-methods study. Research methods included systematic reviews; a longitudinal prospective cohort study in primary care to identify people with LTCs at risk of EHA or ED admission; a replication study in primary care using routinely collected data; an exploratory and feasibility cluster randomised controlled trial in primary care; and qualitative studies to identify personal reasons for the use of unscheduled care and factors in routine consultations in primary care that may influence health-care use. People with lived experience of LTCs worked closely with the research team. Setting Primary care. Manchester and London. Participants People aged ≥ 18 years with at least one of four common LTCs: asthma, coronary heart disease, chronic obstructive pulmonary disease (COPD) and diabetes. Participants also included health-care staff. Results Evidence synthesis suggested that depression, but not anxiety, is a predictor of use of unscheduled care in patients with LTCs, and low-intensity complex interventions reduce unscheduled care use in people with asthma and COPD. The results of the prospective study were that depression, not having a partner and life stressors, in addition to prior use of unscheduled care, severity of illness and multimorbidity, were independent predictors of EHA and ED admission. Approximately half of the cost of health care for people with LTCs was accounted for by use of unscheduled care. The results of the replication study, carried out in London, broadly supported our findings for risk of ED attendances, but not EHAs. This was most likely due to low rates of detection of depression in general practitioner (GP) data sets. Qualitative work showed that patients were reluctant to use unscheduled care, deciding to do so when they perceived a serious and urgent need for care, and following previous experience that unscheduled care had successfully and unquestioningly met similar needs in the past. In general, emergency and primary care doctors did not regard unscheduled care as problematic. We found there are missed opportunities to identify and discuss psychosocial issues during routine consultations in primary care due to the ‘overmechanisation’ of routine health-care reviews. The feasibility trial examined two levels of an intervention for people with COPD: we tried to improve the way in which practices manage patients with COPD and developed a targeted psychosocial treatment for patients at risk of using unscheduled care. The former had low acceptability, whereas the latter had high acceptability. Exploratory health economic analyses suggested that the practice-level intervention would be unlikely to be cost-effective, limiting the value of detailed health economic modelling. Limitations The findings of this programme may not apply to all people with LTCs. It was conducted in an area of high social deprivation, which may limit the generalisability to more affluent areas. The response rate to the prospective longitudinal study was low. The feasibility trial focused solely on people with COPD. Conclusions Prior use of unscheduled care is the most powerful predictor of unscheduled care use in people with LTCs. However, psychosocial factors, particularly depression, are important additional predictors of use of unscheduled care in patients with LTCs, independent of severity and multimorbidity. Patients and health-care practitioners are unaware that psychosocial factors influence health-care use, and such factors are rarely acknowledged or addressed in consultations or discussions about use of unscheduled care. A targeted patient intervention for people with LTCs and comorbid depression has shown high levels of acceptability when delivered in a primary care context. An intervention at the level of the GP practice showed little evidence of acceptability or cost-effectiveness. Future work The potential benefits of case-finding for depression in patients with LTCs in primary care need to be evaluated, in addition to further evaluation of the targeted patient intervention