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Abstract We conducted a rapid review examining the effectiveness of organisational interventions intended to improve job-related wellbeing of adult employees working from home. A systematic search was conducted on MEDLINE, PsycINFO, and Social Sciences Citation Index in June 2021. Studies were included of adult employees working from home, with wellbeing interventions implemented by organisations for all (or groups of) employees and study designs with any (or no) comparator group. Outcomes were quantitative/qualitative data related to employee psychological and subjective well-being. A total of 1906 unique records were retrieved, of which five studies with a total of 332 participants were included. All five studies included an online intervention, and each had a different type of intervention: well-being and performance coaching; positive psychology coaching; employee empowering sessions; corporate wellbeing programme; and yoga. Interventions showed a pattern of reducing stress levels and enhancing wellbeing. Review results should be interpreted with caution due to study small sample sizes, occurring during the pandemic and having inactive control or no control group, which may mean fluctuating levels of stress unrelated to interventions. The nature of the rapid review meant grey literature may have yielded more studies. This review was registered on Prospero (CRD42021262655).

Background Winter pressures are a familiar phenomenon within the National Health Service and represent the most extreme of many regular demands placed on health and social care service provision. This review focuses on a part of the pathway that is particularly problematic: the discharge process from hospital to social care and the community. Although studies of discharge are plentiful, we identified a need to focus on identifying interventions and initiatives that are a specific response to ‘winter pressures’. This mapping review focuses on interventions or initiatives in relation to hospital winter pressures in the United Kingdom with either discharge planning to increase smart discharge (both a reduction in patients waiting to be discharged and patients being discharged to the most appropriate place) and/or integrated care. Methods We conducted a mapping review of United Kingdom evidence published 2018–22. Initially, we searched MEDLINE, Health Management Information Consortium, Social Care Online, Social Sciences Citation Index and the King’s Fund Library to find relevant interventions in conjunction with winter pressures. From these interventions we created a taxonomy of intervention types and a draft map. A second broader stage of searching was then undertaken for named candidate interventions on Google Scholar (Google Inc., Mountain View, CA, USA). For each taxonomy heading, we produced a table with definitions, findings from research studies, local initiatives and systematic reviews and evidence gaps. Results The taxonomy developed was split into structural, changing staff behaviour, changing community provision, integrated care, targeting carers, modelling and workforce planning. The last two categories were excluded from the scope. Within the different taxonomy sections we generated a total of 41 headings. These headings were further organised into the different stages of the patient pathway: hospital avoidance, alternative delivery site, facilitated discharge and cross-cutting. The evidence for each heading was summarised in tables and evidence gaps were identified. Conclusions Few initiatives identified were specifically identified as a response to winter pressures. Discharge to assess and hospital at home interventions are heavily used and well supported by the evidence but other responses, while also heavily used, were based on limited evidence. There is a lack of studies considering patient, family and provider needs when developing interventions aimed at improving delayed discharge. Additionally, there is a shortage of studies that measure the longer-term impact of interventions. Hospital avoidance and discharge planning are whole-system approaches. Considering the whole health and social care system is imperative to ensure that implementing an initiative in one setting does not just move the problem to another setting. Limitations Time limitations for completing the review constrained the period available for additional searches. This may carry implications for the completeness of the evidence base identified. Future work Further research to consider a realist review that views approaches across the different sectors within a whole system evaluation frame. 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: NIHR130588) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 31. See the NIHR Funding and Awards website for further award information. Plain language summary Every year, the National Health Service struggles with huge care demands from people with heart and lung problems. This ‘mapping review’ aimed to chart the evidence around what has been done to minimise winter pressures related to discharge planning, by helping people leaving hospital sooner, and by optimising integrated care (also known as ‘collaborative care’) and to make suggestions for future research. Good research evidence was identified for three specific approaches: Acute medical units: these units provide rapid assessment, diagnosis and treatment for adults referred by their general practitioner or the emergency department. Discharge to assess: this involves discharging patients who need care services but not an acute hospital bed. Patients are either discharged home or are transferred to an appropriate community setting with short-term funded support while their future care needs are assessed. Hospital at home: this approach provides patients with the care they need at home instead of in hospital (also known as virtual wards). The evidence for many other activities to reduce winter pressures was weaker, coming from case studies, conference presentations or small, low methodological quality (poorly designed or executed) research studies. The review identified many different initiatives with diverse names or labels and it is also important to consider how implementing an initiative in one setting might affect another setting. Further research is recommended around what works best for which patient groups, under what circumstances and why, based on common processes within the different initiatives and across the whole health and social care system. Scientific summary Introduction The term ‘winter pressures’ refers to ‘how hospitals cope with the challenges of maintaining regular service over the winter period’. Attention often focuses on additional demands on accident and emergency services but pressures are exerted in terms of increased demand across the entire health and social care system. Increased prevalence of respiratory and cardiovascular illnesses during the winter places severe demands upon systems that already face difficulties in matching service provision to demand. Better or earlier planning and/or increasing service provision across integrated care systems and related sectors, such as housing, constitute just two of the possible responses to increased demand. Winter pressures are a familiar phenomenon within the National Health Service and represent the most extreme of many regular demands placed on health service provision. The impact of winter pressures is pervasive and operates along a continuum from public health, in mitigation via immunisation campaigns, through to discharge into social care and the community. Interventions target multiple points along this continuum, as well as whole-system approaches. This mapping review focuses on one stage of the pathway, considered particularly problematic, namely the discharge process from hospital. Studies of discharge interventions and transfers of care are plentiful and international initiatives have been reviewed in a recent scoping review. However, a considerable challenge lies in identifying interventions that specifically are articulated as an explicit response to ‘winter pressures’. There is strong rationale for focusing on the subgroup of ‘winter pressure’ interventions as specific interventions implemented in response to acute and severe system pressure. This contrasts with interventions that seek to improve discharge within a system in ‘steady state’. While commentators on the current context articulate that the system experiences ‘winter pressures’ all year round, until recently, responses have targeted the context of winter pressures. Potentially, this set of studies therefore represents a highly relevant evidence base on discharge related interventions to inform current National Health Service (NHS) planning. This mapping review aims to chart and document the evidence in relation to winter pressures in the United Kingdom, together with either discharge planning to increase discharge (both a reduction in patients waiting to be discharged and patients being discharged to the most appropriate place) and/or integrated care. For the purposes of this review, ‘integrated care’ involves partnerships of organisations that come together to plan and deliver joined-up health and care services within NHS England. The primary objective of the mapping review is to address the question: Which interventions in relation to discharge planning/integrated care have been suggested, tried or evaluated in seeking to address winter pressures in the United Kingdom? The secondary review question is: Which research or evaluation gaps exist in relation to service- or system-level interventions as a response to discharge planning/integrated care in the context of winter pressures? In addressing this question the mapping review will seek: To identify a potential winter pressures research agenda in relation to discharge planning/integrated care to inform commissioning of future research. Methods We conducted a mapping review of UK evidence published 2018–22. For the mapping review, we used a two-stage search process to search for the evidence. Initially, we searched MEDLINE, Health Management Information Consortium, Social Care Online, Social Sciences Citation Index and the King’s Fund Library to find relevant interventions. The search was broad for terms for winter pressures. Searches on Google Scholar (Google Inc., Mountain View, CA, USA), which searches the full text instead of just title and abstract, included terms for discharge and integrated care. Study screening and selection was undertaken in Microsoft Excel® (Microsoft Corporation, Redmond, WA, USA) by three reviewers who independently screened the title and abstracts of the 723 references that were retrieved by the search. Study eligibility was based on following aspects – population, exposure, comparative, outcome(s), study types: users of UK health and/or social care systems (population) winter pressures impacting on discharge, to social care and the community, and integrated care (exposure) other foreseeable, unusual or exceptional periods of demand (if appropriate) (comparison – may or may not be present) increased smart discharge (both a reduction in patients waiting to be discharged and patients being discharged to the most appropriate place), system effects, health and health service outcomes, effects on patients, carers and staff (outcomes) eligible types of study design (primary research study, evidence synthesis or research report) (study types). To classify within the broader thematic groups of interventions, we developed a taxonomy documenting the candidate interventions together with other relevant supporting literature. Our team started from categories developed by the Cochrane Effective Practice and Organisation of Care Group for their systematic reviews of discharge planning. These were further expanded using categories from a rapid review produced by the Centre for Clinical Effectiveness, Monash University. This process resulted in the following broad groupings: structural, changing staff behaviour, changing community provision, integrated care and targeting carers. The draft taxonomy was reviewed for parsimony (to minimise duplication of concepts) and comprehensiveness (to include all named interventions identified to date). However, published commentary has documented the non-exclusivity and lack of precision of existing labels. Following the production of the draft map using the taxonomy, we decided to further split the taxonomy headings to represent contributions to the patient pathway: hospital avoidance, alternate delivery site, facilitated discharge and cross-cutting. The modelling and workforce planning groupings were not considered as within scope because of their limited relevance to short-term alleviation of winter pressures and were therefore discarded. The second stage of searching consisted of searches for named candidate interventions from the literature and current practice on Google Scholar. The second stage was to identify where possible reviews, ideally systematic reviews, and these searches were broader than winter pressures but were limited to research published from 2012 to 2022. The second-stage searches helped in completing the intervention tables and identifying the evidence gaps. Research priorities were classified as high, moderate or low and further classified by the nature of the evidence gap(s) identified (research gap, synthesis gap and/or implementation gap). Results The taxonomy consists of a total of 41 headings. These headings were further organised into the different contributions to the patient pathway: hospital avoidance, alternative delivery site, facilitated discharge and cross-cutting. The evidence for each heading was provided and this helped with identification of the evidence gaps. Within structural interventions for the hospital avoidance part of the patient pathway research gap were identified for same-day emergency care and research and implementation gaps for surgical hubs. The alternative delivery sites subsection is populated by systematic review evidence for the effectiveness of acute medical units, other specialist units developing using winter funding need to be fully evaluated. Models based on ‘discharge to assess’ (also ‘home first’ and others) within facilitated discharge are relatively well researched. Some taxonomy headings (e.g. ‘bed management’ and ‘discharge co-ordinators’) were often evaluated within a broader process of ‘discharge planning’. ‘Patient flow’ is another broad heading with some overlap with both bed management and discharge planning. The concept of patient flow is also broader than facilitated discharge, although its ultimate goal is ensuring safe discharge as soon as is clinically appropriate. The evidence base for initiatives defined as ‘cross-cutting’ varied widely and was characterised by case studies with a lack of research studies. Community provision initiatives and integrated care were heterogeneous and characterised by multiple diverse initiatives, largely unevaluated, and by involvement of multiple contributors and sectors. Overall, the evidence base is characterised by large numbers of case studies, often published online or presented at conferences, and relatively few peer-reviewed journal articles. Case studies are often accompanied by guidance to support implementation of changes to services. This distribution of evidence probably reflects the urgent need to develop and implement solutions to the ever increasing winter (and increasingly year round) pressures on the health and care system. The majority of evaluations report positive effects on important outcomes such as length of hospital stay but many are uncontrolled or based on small samples, meaning that they need to be interpreted with caution. Conclusions Few initiatives identified were specifically implemented as a response to winter pressures. Hospital at home, as a heavily used intervention, was well-supported by the evidence but other responses, while also heavily used, were based on limited evidence. There is a lack of studies considering patient, family and provider needs when developing interventions aimed at improving delayed discharge. Additionally, few studies measure the impact of interventions over a long time; short-term results can appear promising but evidence for longer-term sustainability is notably absent. Hospital avoidance and delayed discharge requires a whole-system approach. It is imperative to consider the whole system to ensure that implementing an initiative in one setting does not just move the problem to another setting. Limitations Time limitations for completing the review constrained the period available for additional searches with a focus on systematic reviews and high-profile studies. This carries implications for the variability of coverage and completeness of the evidence base identified. Implications for service delivery Effective interventions to avoid hospital admission, deliver services in different settings and facilitate discharge are key to reducing short-term acute pressures on health and social care. These pressures are generally associated with the winter period but have increasingly been experienced throughout the year and are particularly acute at the time of writing (January 2023). Longer-term improvements to service delivery may require policy changes related to investment and workforce planning that are outside the scope of this review. Implications for research We identified high priority topics for primary research and evaluation in all the broad groupings of taxonomy headings as follows: Changing community provision: private sector, step-up facilities. Changing staff behaviour: clinical audit, quality improvement programmes, protocols/guidelines, quality management systems. Integrated care: integrated care discharge huddle. Structural (S): bed management, extra service delivery, governance, monitoring and review, same-day services, specialist units, volunteers. In terms of evidence synthesis, our detailed exploration further supports the need for a realist review that views approaches across the different sectors within a whole-system evaluation frame. Further evidence synthesis should consider identified synthesis gaps in research within the aforementioned areas. 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: NIHR130588) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 31. See the NIHR Funding and Awards website for further award information.

Background Signposting typically refers to an informal process that involves giving information to patients to enable them to access external services and support. It is perceived to reduce demand on primary care and other urgent care services. Methods This focused realist review was conducted rapidly within time constraints. Searches to identify theory were undertaken on MEDLINE, Cumulative Index to Nursing and Allied Health Literature and Social Sciences Citation Index in June 2022 for research published in English from 2016. We selected 22 publications and extracted programme theories from these to develop three priority questions: Question 1: What do people with health and social care needs require from a signposting service to believe it is valuable? Question 2: What resources do providers require to confidently deliver an effective signposting service? Question 3: Under what circumstances should commissioners commission generic or specialist signposting services? Purposive searching was conducted to find a rich sample of studies. UK studies were prioritised to optimise the applicability of synthesis findings. Results The review included 27 items, 4 reviews and 23 studies, a mix of qualitative, evaluations and case studies. Service users value a joined-up response that helps them to navigate the available resources. Key features include an understanding of their needs, suggestion of different options and a summary of recommended actions. Only a small number of service user needs are met by signposting services alone; people with complex health and social care needs often require extended input and time. Front-line providers of signposting services require appropriate training, ongoing support and supervision, good knowledge of relevant and available activities and an ability to match service users to appropriate resources. Front-line providers need to offer a flexible response targeted at user needs. Commissioned signposting services in England (no studies from Scotland, Wales and Northern Ireland) are highly diverse in terms of client groups, staff delivering the service, referral routes and role descriptions. A lack of service evaluation poses a potential barrier to effective commissioning. A shortage of available services in the voluntary and community sector may limit the effectiveness of signposting services. Commissioners should ensure that referrals target intensive support at patients most likely to benefit in the longer term. Conclusions Signposting services need greater clarity of roles and service expectations to facilitate evaluation. Users with complex health and social care needs require intensive, repeat support from specialist services equipped with specific knowledge and situational understanding. A tension persists between efficient (transactional) service provision with brief referral and effective (relational) service provision, underpinned by competing narratives. Do signposting services represent ‘diversion of unwanted demand from primary care/urgent care services’ or ‘improved quality of care through a joined-up response by health, social care and community/voluntary services’? Limitations This realist review was conducted within a tight time frame with a potential impact on methodology; for example, the use of purposive searching may have resulted in omission of relevant evidence. Future work Signposting services require service evaluation and consideration of the issue of diversity. Study registration This study is registered as PROSPERO CRD42022348200. 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: NIHR130588) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 26. See the NIHR Funding and Awards website for further award information. Plain language summary Signposting points people to information, help or advice that they should find useful. Signposting can be delivered face to face, by phone, or virtually, by technology. This review of research brings together what is already known. We have not collected any data ourselves. The review uses realist synthesis. This method tries to understand the whys and ways (the mechanisms and theories) of how things work (or do not work!). It goes beyond whether something works (is effective). It tries to explain why something might work for some people but not others. For example, why an approach may not be helpful for people with disabilities, why it might work in some places but not others and exactly what leads to what effects (what are the ‘key ingredients’). The report answers the following three questions: What do people with health and social care needs require from a signposting service to enable them to believe it is a valuable and useful service? What resources do people providing signposting services require to ensure that they can confidently provide effective signposting services? How can commissioners/funders specify, monitor and evaluate signposting services (generic or specific) to optimise value for money and outcomes for service users? Specifically, do any factors favour funding general over specialist services and vice versa? The diversity of signposting services within health or across social and community services, including voluntary services, makes them difficult to evaluate and compare. Within each service, different people undertake signposting roles: from general practitioners, practice nurses or receptionist to a standalone signposting role, each for a different purpose and intensity. Only a small number of service users potentially benefit from signposting-only services. Many service users have complex health and social care needs and, therefore, need different support extended over a longer time. Scientific summary Introduction Signposting is an informal process that involves giving information to patients to enable them to access external, usually non-clinical, services and support (Harris E, Barker C, Burton K, Lucock M, Astin F. Self-management support activities in primary care: a qualitative study to compare provision across common health problems. Patient Educ Couns 2020;103:2532–9. https://doi.org/10.1016/j.pec.2020.07.003). Signposting also includes self-referral, which often requires patients to contact health and support services by telephone or the internet. Signposting may also take place within clinical interactions or within more extensive social prescribing. Methods A protocol was developed that received input from commissioning and patient and public involvement representatives. This study used realist synthesis to answer three key questions. Information about each is provided below. Initial searches to identify theory were conducted on MEDLINE, Cumulative Index to Nursing and Allied Health Literature and the Social Sciences Citation Index for research published in English from 2016 to current in June 2022. The broad search retrieved 716 unique references and the focused search retrieved 31 references. One reviewer (AB) reviewed the results of the focused and then the broader search and selected 22 studies to use for theory identification. The three reviewers divided these studies between them and extracted initial programme theories in the form of context–mechanism–outcome (CMO) configurations: IF (context) – THEN (mechanism) – LEADING TO (outcome) statements. Extracted data related to IF (WHO? DO WHAT? FOR WHOM?) THEN (THE RESPONSE IS) LEADING TO (WHAT OUTCOMES? FOR WHOM?) followed by the reference source. The team prioritised complete (i.e. three-element) CMO configurations, whenever possible. A limited number of two-element CMO configurations were included when they provided unique insights, for completeness. The signposting programme theories identified are provided in the report. All CMO configurations were checked by a single reviewer experienced in realist synthesis to ensure that they were complete, in a common format, and that the agency (i.e. who was the agent for action) could be identified. The review team then met to discuss the initial programme theories and identified a need to address three complementary perspectives: those of the service user, service provider and commissioner. Identification of programme theory led to the development of a priority question constructed to match each perspective. Question 1 (value and usefulness of signposting) considers the service user perspective: What do people with health and social care needs require from a signposting service to believe it is a valuable and useful service? Question 2 (required resources) considers the perspective of the front-line provider of the signposting service: What resources (training, directories/databases, credible and high-quality services for referral) do providers of front-line signposting services require to confidently deliver effective signposting services? Question 3 (specification, monitoring and evaluation) considers the viewpoint of the commissioner/funder: Under what circumstances should commissioners commission generic or specialist signposting services? Purposive searching was undertaken for each question to find a sample of rich relevant studies. The searching included forward and backward citation searching of relevant studies from the theories searches, focused searches and searching for UK initiatives. Where possible, we predominantly included UK studies to optimise the usefulness of the synthesis findings with a UK context and included studies based on richness, rigour and relevance. All documents with signposting in the title were included along with any qualitative studies of social prescribing and care navigation with multiple occurrences of ‘signposting’ in the full text. Studies from other comparable countries were included where relevant. Several studies supplied data to address more than one question and were therefore included in multiple sections. Formal quality appraisal was not undertaken. An online meeting of the Health Service and Delivery Research Sheffield Evidence Synthesis Centre Public Advisory Group met to provide input into the review. The group were asked about their understanding of the term signposting and their experiences of accessing signposting services. Question 1: What do people with health and social care needs require from a signposting service to believe it is a valuable and useful service? (Service user perspective) Findings for Question 1 are organised under the four identified subquestions. A total of 19 items of evidence were reviewed including 4 reviews and 15 individual items reporting UK studies or service evaluations. The nature of the question meant that studies were mainly qualitative or mixed-methods studies with one quantitative study in the included evidence. Summary of findings for Question 1 (value and usefulness: service user perspective) Service users value a ‘linking’ or ‘joined-up’ response that helps them to navigate resources offered by different organisations and/or by different sectors and helps them to reach an appropriate destination. Key features from a service user viewpoint are an understanding of their needs, presentation of options (together with alternatives if required) and a summary of the recommended action to be taken. This needs to be supported by appropriate matching of opportunities to their needs and resourced provision and capacity so that they can pursue these opportunities. Above all, a signposting service must reduce the ‘patient burden’ encountered in contacts with formal health services when trying to pursue options and alternatives. A key consideration is whether signposting services are conceived to operate in isolation or whether they form the front end of an integrated pathway of care with multiple routes and outcomes. The needs of only a small proportion of those targeted by signposting services are met by signposting services alone. Where people with complex needs interact with signposting services, interaction may require extended time or multiple episodes. Alternatively, they may perceive that their needs were imperfectly or incompletely met by a brief intervention. Effective use of signposting, which requires a clear, and often detailed, understanding of service user needs, may operate against a programme theory that conceives them as an efficient brief intervention to divert service users away from formal health services towards wider resources in the community. Question 2: What resources (training, directories/databases, credible and high-quality services for referral) do providers of front-line signposting services require to confidently deliver effective signposting services? (Service provider perspective) For Question 2, a total of 14 items of evidence were reviewed including 1 review and 13 individual items reporting UK, USA or Canadian studies or service evaluations. The findings from the included studies are discussed within themes. Summary of findings for Question 2 (required resources: service provider perspective) Front-line providers of signposting services require appropriate training, ongoing support and supervision. Front-line providers of signposting services require good knowledge of relevant health, social care, community, voluntary or other agency activities and opportunities to which they feel empowered to refer. Front-line providers of signposting services need be able to match appropriate services or resources to the needs of a service user – this may take time, extensive interaction and the creation of trust over time. Front-line providers of signposting services need to provide a flexible response in order to meet very diverse levels and types of individual needs. Requirements may also differ according to differing levels of availability of complementary services (e.g. where separate health and social care signposting services coexist or not). For a signposting service to be considered useful, those providing signposting services must be confident that, even in times of resource constraint, sufficient appropriate, high-quality resources exist to which they can refer. Question 3: How can commissioners/funders specify, monitor and evaluate signposting services (generic or specific) to optimise value for money and outcomes for service users? Specifically, are there factors that favour funding of generic versus specialist services or vice versa? (Service commissioner/funder perspective) For Question 3, a total of four items of evidence were reviewed; data were extracted from a survey of Clinical Commissioning Groups in England; evaluations of a social prescribing service and a primary care diabetes care navigation service; and a qualitative study of a new care model in Child and Adolescent Mental Health Services. Commissioned signposting services in England (no studies from Wales and Northern Ireland) are highly diverse in terms of client groups, staff delivering the service, referral routes and how the role is described. Evaluation of services is uncommon and is a potential barrier to effective commissioning. Lack of availability of services in the voluntary and community sector may limit the effectiveness of signposting/care navigation in both primary and secondary care and their potential to reduce urgent care use and improve well-being in service users. Brief signposting interventions are sufficient for some service users. Others require intensive support to overcome barriers to engagement with either the care signposting/care navigation process or, subsequently, services to which they are referred. From the commissioner perspective, it is important that referral processes provide intensive support to those most likely to benefit in the longer term. Summary of integrated findings across the three perspectives (service user, service provider and service commissioner/funder) Clarity of roles and expectations is required within signposting services. Signposting services may operate within health or across social and community services including voluntary service provision. Those signposting may include this role within wider clinical [general practitioner (GP) or practice nurse] or administrative roles (receptionists), as one of many functions within tailored social prescribing or care navigation roles, or as a standalone signposting role. This makes evaluation and comparison challenging. Only a small number of service users potentially benefit from signposting-only services. Many users have complex health and social care needs that require intensive and repeated support. Specialist services demand greater empathy, knowledge and situational understanding and so are likely to extend beyond signposting. Service users and service providers need to develop a shared confidence in the signposting role. This requires good communication skills and training, backed up with resources, to firstly identify activities and opportunities and then for adequate levels of resource provision to enable them to be accessed and used. The tension between (1) efficient (transactional) service provision with brief referral and (2) effective (relational) service provision, requiring detailed understanding of individual service user needs, remains unreconciled. This tension is underpinned by competing narratives of ‘diversion of unwanted demand from primary care and other urgent care services’ and of ‘improved quality of care through a joined-up response that encompasses health, social care and community/voluntary services’. Conclusion Signposting services need to achieve greater clarity around roles and the expectations of the service to enable thorough evaluation. Evaluation and comparisons are challenging; signposting services which operate within health or across social and community services, including voluntary service provision, are diverse. The diversity of signposting roles and services makes evaluation and comparisons challenging. Within each service, roles may vary in function and intensity from a recognisable signposting function within a wider clinical (GP or practice nurse) or administrative role (receptionists) through one of many components within tailored social prescribing or care navigation roles to a standalone signposting role. Commissioners of services need to recognise that the complex health and social care needs of many service users require intensive and repeated support. Specialist services demand greater empathy, knowledge and situational understanding, and thus contact is likely to extend in time and scope beyond straightforward signposting. Service users and service providers need to develop a shared confidence in the signposting role. This requires good communication skills and training together with resources; first, to identify relevant activities and opportunities and then to enable service users to access them. The tension between efficient (transactional) service provision with brief referral and effective (relational) service provision, which requires a detailed understanding of individual service user needs, remains unreconciled. This tension is underpinned by competing narratives of whether signposting represents ‘diversion of unwanted demand from primary care and other urgent care services’ or ‘improved quality of care through a joined-up response that encompasses health, social care and community/voluntary services’. Research gaps and priorities The review identified the following research gaps and priorities: There is a need to evaluate different levels of intensity of service provision and their differential benefits and value for money. Productive comparison and evaluation (through benchmarking and audit) of similar services is required (i.e. signposting services to be compared with similar brief services and services providing more intensive and sustained to be compared with similar). Further comparison and evaluation of signposting services could explore levels of service provided by different staff roles. Specialist services may particularly benefit from evaluation tailored to the needs and objectives of each specific service. Issues of cultural diversity are absent from the literature particularly, as they relate to setting up a service; thus, we have identified a need for research around setting up and providing services for diverse populations. Research examining the impact of economic constraints on informal social provision would be potentially informative. Further consideration of the extent to which each service developed should prioritise and manage brief interactions with large numbers of generic users or sustained, and even prolonged, support to a targeted user group with complex health and social needs. Study registration This study is registered as PROSPERO CRD42022348200. 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: NIHR130588) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 26. See the NIHR Funding and Awards website for further award information.

Background The relationship between nutrition and health is complex and the evidence to describe it broad and diffuse. This review brings together evidence for the effect of nutrients on cardiometabolic risk factors.Methods An umbrella review identified systematic reviews of randomised controlled trials and meta-analyses estimating the effects of fats, carbohydrates and sodium on blood pressure, cholesterol and haemoglobin A1c (HbA1c). Medline, Embase, Cochrane Library and Science Citation Index were search through 26 May 2020, with supplementary searches of grey literature and websites. English language systematic reviews and meta-analyses were included that assessed the effect of sodium, carbohydrates or fat on blood pressure, cholesterol and HbA1c. Reviews were purposively selected using a sampling framework matrix. The quality of evidence was assessed with A MeaSurement Tool to Assess systematic Reviews 2 (AMSTAR2) checklist, evidence synthesised in a narrative review and causal pathways diagram.Results Forty-three systematic reviews were included. Blood pressure was significantly associated with sodium, fibre and fat. Sodium, fats and carbohydrates were significantly associated with cholesterol. Monounsaturated fat, fibre and sugars were associated with HbA1c.Conclusion Multiple relationships between nutrients and cardiometabolic risk factors were identified and summarised in an accessible way for public health researchers. The review identifies associations, inconsistencies and gaps in evidence linking nutrition to cardiometabolic health.

Abstract Background With millions of unscheduled patient contacts every year and increasing call outs clustered around the most deprived communities, it is clear the ambulance sector could have a role to play in improving population health. However, the application and value of a public health approach within the ambulance sector has not been comprehensively explored. A scoping review was undertaken to explore the role of the ambulance sector in the delivery of public health interventions and what impact this has on population health and ambulance sector outcomes. Methods A search strategy was developed on MEDLINE and translated to other major medical and health related bibliographic databases (Embase; CINAHL; HMIC; Science and Social Sciences Citation Index; Cochrane Library) to identify literature published since 2000 in OECD countries. Targeted grey literature, reference list, and citation searching was also carried out. Search results were downloaded to Microsoft Excel and screened by three reviewers according to pre-determined inclusion / exclusion criteria. Data from included studies, such as the type of activity noted within the paper, the population involved and the public health approach that was utilised, was extracted from within the paper using a data extraction form and narratively synthesised. Results Fifty-two references were included in the final review (37 database searching; 9 reference list searching; 6 grey literature). Included articles were categorised according to the relevant public health domains and subdomains as articulated by the UK Faculty of Public Health: 1. Health improvement domain: Public health education and advice (Health promotion sub-domain) (n=13) Emergency Services personnel providing vaccines (Disease prevention sub-domain) (n=1) 2. Health care public health domain Paramedicine (Service delivery sub-domain) (n=30) Screening tools and referral pathways used by the ambulance sector (Service delivery sub-domain) (n=28) Health intelligence using ambulance sector data (population health management sub-domain) (n=26) Of note, some domains (e.g. health protection) returned nil results. Discussion The scoping review demonstrates the breadth of public health related activities in which the ambulance sector is involved. However, an overemphasis on demand management outcomes precludes definitive conclusions on the impact of ambulance sector-led public health initiatives on public health outcomes. Future evaluations of public health initiatives should incorporate wider health system perspectives beyond the immediately apparent remit of the ambulance sector.

Background Risk assessment is a key process when a child or adolescent presents at risk for self-harm or suicide in a mental health crisis or emergency. Risk assessment by a healthcare professional should be included within a biopsychosocial assessment. However, the predictive value of risk-screening tools for self-harm and suicide in children and adolescents is consistently challenged. A review is needed to explore how best to undertake risk assessment and the appropriate role for tools/checklists within the assessment pathway. Aims To map research relating to risk assessment for child and adolescent mental health and to identify features that relate to a successful risk assessment. Objectives To review factors within the clinical encounter that impact upon risk assessments for self-harm and suicide in children and adolescents: to conduct a realist synthesis to understand mechanisms for risk assessment, why they occur and how they vary by context to conduct a mapping review of primary studies/reviews to describe available tools of applicability to the UK. Data sources Databases, including MEDLINE, PsycINFO®, EMBASE, CINAHL, HMIC, Science and Social Sciences Citation Index and the Cochrane Library, were searched (September 2021). Searches were also conducted for reports from websites. Review methods A resource-constrained realist synthesis was conducted exploring factors that impact upon risk assessments for self-harm and suicide. This was accompanied by a mapping review of primary studies/reviews describing risk-assessment tools and approaches used in UK child and adolescent mental health. Following piloting, four reviewers screened retrieved records. Items were coded for the mapping and/or for inclusion in the realist synthesis. The review team examined the validity and limitations of risk-screening tools. In addition, the team identified structured approaches to risk assessment. Reporting of the realist synthesis followed RAMESES guidelines. Results From 4084 unique citations, 249 papers were reviewed and 41 studies (49 tools) were included in the mapping review. Eight reviews were identified following full-text screening. Fifty-seven papers were identified for the realist review. Findings highlight 14 explanations (programme theories) for a successful risk assessment for self-harm and suicide. Forty-nine individual assessment tools/approaches were identified. Few tools were developed in the UK, specifically for children and adolescents. These lacked formal independent evaluation. No risk-screening tool is suitable for risk prediction; optimal approaches incorporate a relationship of trust, involvement of the family, where appropriate, and a patient-centred holistic approach. The objective of risk assessment should be elicitation of information to direct a risk formulation and care plan. Limitations Many identified tools are well-established but lack scientific validity, particularly predictive validity, or clinical utility. Programme theories were generated rapidly from a survey of risk assessment. Conclusions No single checklist/approach meets the needs of risk assessment for self-harm and suicide. A whole-system approach is required, informed by structured clinical judgement. Useful components include a holistic assessment within a climate of trust, facilitated by family involvement. Study registration This study is registered as PROSPERO CRD42021276671. 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: NIHR135079) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 1. See the NIHR Funding and Awards website for further award information. Plain language summary When young people up to 18 years of age present to health services, having tried to poison themselves, take an overdose or injure themselves, a health professional needs to work out whether this is likely to happen again (risk assessment). Lists of questions or things to look for (risk screening) have proved unreliable. Thorough discussion with the child or teenager may be helpful but takes much time. How can a health professional best use time spent with a young person to prevent further harm and make sure that they get the treatment that they need? This review focuses on young persons who use health services in the UK. Included studies report how health professionals work out whether young people are likely to harm themselves; either how to handle the overall discussion or to use memory aids or checklists (known as tools) to help the discussion. Tools developed in the USA many years ago have not been tested well enough with UK populations. Recent approaches within the UK are used inconsistently. Young persons do not like how they are assessed. Health professionals may use methods that have not been shown to work or use tools differently from how they were designed. This review identified 14 ways to help a young person have valued discussions with a health professional. Health professionals should not simply ‘tick boxes’; tools should help them gain a full picture, including input from other family members. Health professionals should create a trusted relationship where the young person feels respected and heard. Tools should not label someone ‘at risk’ but should support care that reduces the risk of further harm. Health professionals should gather good-quality information that includes asking about thoughts of suicide. Staff should be supported by training, guidance and feedback from experienced colleagues. Scientific summary Background Risk assessment occupies a central place in the management of children and adolescents who present to acute paediatric care settings at risk for self-harm and suicide. A risk assessment should be included within a detailed clinical assessment that includes evaluation of biological, social and psychological factors that are relevant to the child/adolescent. However, current National Institute for Health and Care Excellence (NICE) guidance cautions against using tools or checklists to predict the risk of suicide (risk screening) and against using risk-screening tools to determine subsequent clinical management. Current guidelines for self-harm (NICE. Self-harm: assessment, management and preventing recurrence NICE guideline [NG225] London: 2022) require a risk formulation as part of every psychosocial assessment, to be conducted a mental health professional who has received training in conducting psychosocial assessments and risk formulation. By gaining an accurate picture of the circumstances of a child or adolescent a mental health professional can target a future pathway to appropriate intervention and treatment. However, evidence from surveys suggests that risk assessment continues to serve its historic functions of protecting the community and avoiding claims of negligence rather than being grounded in the welfare of the child/adolescent. As a consequence risk assessment is not currently harnessing its full potential as an intervention to prevent self-harm and suicide. Numerous risk-assessment tools, including some risk-screening tools, are used across different services and information is neither gathered consistently nor completely. In some cases risk-screening tools are viewed as a tick-box exercise or even used for purposes for which the available tools or checklists are not designed. The focus of this review is on the well-being of the children or adolescents themselves and not on the actuarial function of managing risk of harm to others. Despite extensive numbers of tools and approaches, the relationship between risk assessment for self-harm and suicide and treatment intervention and outcome remains unclear. Uncertainties remain, especially around ‘what works, for whom, and why?’ Aims To map the research literature relating to risk assessment for child and adolescent mental health and then to explore published and ‘grey’ literature through a resource-constrained realist-informed review, Objectives To understand the underlying mechanisms for risk assessment for self-harm and suicide, why they occur and how they vary by context and then to review risk-screening tools currently in use in the UK and similar contexts and to explore how different approaches to using these tools impact upon risk assessment for self-harm and suicide within child and adolescent mental health services (CAMHS). Methods Two complementary reviews were conducted: (1) a realist synthesis; and (2) a mapping review of risk-screening tools and risk-assessment approaches (PROSPERO database registration number: CRD42021276671). Realist synthesis Data sources MEDLINE (including Epub Ahead of Print & In-Process), PsycINFO, EMBASE, CINAHL, HMIC, Science and Social Sciences Citation Index and the Cochrane Library. Importantly, the electronic search was complemented by innovative use of the scite tool as well as forward citation searching via Google Scholar and checking for additional relevant articles from reference lists. Screening criteria and study selection Studies that describe the procedures, format and clinical, patient and family perspectives of the risk-assessment process for self-harm and suicide within a UK setting were identified by the review team and prioritised for analysis. Following piloting of eligibility criteria within the team, titles/abstracts were initially screened by one of the review team. Articles identified as potentially relevant were obtained in full text. Attempts were made to identify unpublished literature, for example guidelines and public reports. The full-text literature was screened independently by a single reviewer. Screening was initially inclusive; to minimise threats posed by use of a single reviewer. Assessment of rigour, relevance and richness In line with realist methodology no formal attempt was made to assess the individual study quality of papers included in the synthesis. No papers were excluded on the basis of study quality. Assessment of rigour was determined by study design with weight being placed upon systematic reviews and good-quality comparative research designs. Additional quality markers comprised relevance: privileging studies conducted within child and adolescent mental health; and richness: according detail provided about the risk-assessment process. See Appendix 3 for included papers. Study characteristics The electronic search strategy identified 4084 unique references. Screening based on titles/abstracts identified 149 articles for full-text screening. Screening of full-text articles identified 29 papers to be included in the review. An additional 28 papers were identified through backwards and forwards citation searching, with 57 papers included in the final realist synthesis. Data extraction Study details (including aim, methodology, findings and implications) were extracted by a single reviewer. Details were then mapped against the 14 programme theories. Data synthesis Data were synthesised using a realist synthesis approach. One member of the review team independently generated programme theories from a survey of clinical risk assessment across the UK. Candidate programme theories were considered by the full review team before being completed and finalised. The lead reviewer then used references identified by the team, supplemented by purposive searching and follow-up of references to locate evidence to support, counter or extend the initial interpretations. The 14 programme theories were confirmed as valid propositions and combined within an overarching programme theory. Mapping review Screening criteria The mapping review used the following inclusion criteria: Population and setting: children or adolescents of 18 years of age or younger considered at risk for self-harm or suicide in the UK. Inclusion was unrestricted by setting. Index (or focal) approach or tool: either an overall approach or specific tool used to undertake a detailed clinical assessment; to include evaluation of biological, social and psychological factors relevant to the child/adolescent and relevant to future risks, limited to suicide and self-harm (risk assessment). Comparator approach or tool: any other approach or tool. Outcomes: test performance (sensitivity, specificity, positive predictive value, negative predictive value, reliability, validity), utility and acceptability. Study design: any empirical design. Reviews, systematic or quasi-systematic. Data sources A comprehensive search of MEDLINE, PsycINFO, EMBASE, CINAHL, HMIC, Science and Social Sciences Citation Index and the Cochrane Library was conducted in September 2021. Targeted ‘grey’ literature searches to identify reports/case studies in websites. Study selection Relevant empirical studies and systematic reviews were identified and screened by single review from one of the team to identify reports of approaches and tests used in a UK context for risk assessment for self-harm and suicide. Study characteristics From 4996 citations limited to the UK, 912 duplicates were removed leaving 4084 unique citations. In total, 249 papers were reviewed at full-text and 41 studies were included in the mapping review. For the mapping of reviews 1743 citations were identified; 499 duplicates were removed leaving 1244 unique review citations. Following full-text screening 8 reviews remained. Data extraction and quality assessment Secondary data were extracted on study and population characteristics, tool details and methods of evaluation. No data were available on the resource implications of use of tools or approaches. However, mention was made of the prohibitive time required to conduct a thorough biopsychosocial assessment within the context of an emergency or crisis. Quality appraisal was conducted independently using the Mixed Methods Appraisal Tool (MMAT) tool, and disagreements were resolved through discussion. Data synthesis Findings from the mapping review of tools and approaches were presented using narrative synthesis, using textual and tabular presentation. Studies were not sufficiently homogeneous to permit meta-analysis. Public and patient involvement The research team worked with the standing public and patient advisory group for the Sheffield Evidence Synthesis Centre. The group regularly feeds into the conduct and dissemination of evidence syntheses commissioned by the National Institute for Health Research, providing perspectives on contextual factors and key messages to ensure benefit and relevance for service users. Results Results from the realist synthesis Fourteen programme theories were identified and tested. These included 11 propositions relating to the conduct of risk assessment for self-harm and suicide and a further three propositions relating to what is considered unhelpful. Candidate Programme Theory Components Identified from the Literature Through this preliminary review, successful interventions are considered to require the following: IF risk-assessment approaches are simple, accessible and part of a wider assessment process THEN staff are able to generate standardised, informative and clinically useful assessments LEADING TO appropriate use of support and services. IF clinical staff focus clinical risk-assessment processes on building relationships THEN clinicians and adolescents trust each other LEADING TO frank and open communication within the clinical encounter. IF the emphasis of clinical risk-assessment processes is on gathering good-quality information on (i) the current situation, (ii) past history and (iii) social factors THEN staff use information to inform a collaborative approach to management LEADING TO coordinated and integrated care. IF staff are comfortable asking young patients about suicidal thoughts THEN young service users share relevant information concerning their circumstances LEADING TO an appropriate service response. IF risk-assessment processes are conducted consistently across mental health services THEN the quality of response to young service users does not depend upon each individual contact LEADING TO the availability of consistent information across services. IF staff are trained in how to assess, formulate and manage risk, including appropriate referral THEN staff feel equipped to manage the risks for children and adolescents who present to health services LEADING TO an emphasis on positive risk taking. IF staff are supported by on-going supervision THEN staff feel able to deliver a consistent approach to risk assessment LEADING TO a reduction in adverse events. IF families and carers are involved in the assessment process THEN families and carers are given an opportunity to express their views on potential risk LEADING TO a collaboratively developed risk-management plan. IF mental health staff communicate risk assessments with primary care THEN young people are directed to appropriate care LEADING TO successful health outcomes. IF the management of risk is personal and individualised THEN young people don’t see their care as ‘protocol driven’ and won’t feel alienated LEADING TO their engagement with care. IF organisations involved in risk assessment utilise a whole-system approach THEN this strengthens the standards of care for everyone, LEADING TO the safe management of supervision, delegation and onward referral. Three ‘counter programme theories’ relate to how risk assessment might result in unintended consequences: IF staff view risk-assessment tools as a way of predicting future suicidal behaviour THEN staff incorrectly interpret individual levels of need for care LEADING TO inappropriate use of restrictive practices, such as involuntary hospitalisation, restraint, sedation and seclusion (for the service user). IF clinicians use risk-screening tools and scales in isolation within the risk-assessment process THEN treatment decisions are determined by a score LEADING TO incorrect interpretation of individual need for care and inappropriate utilisation of CAMHS (for the service). IF staff develop tools for risk assessment locally THEN checklists and scales lack formal psychometric evaluation LEADING TO limited clinical utility of tools for risk assessment and unnecessarily restrictive treatment options. Exploring the 11 positive propositions helped in the identification of five particularly useful features include the following: (1) incorporation of tools within wider standardised and consistent assessment processes; (2) trusted relationships that encourage clear and open communication, including family involvement; (3) good-quality information within a personalised and individualised approach; (4) appropriate training and supervision; and (5) appropriate interagency communication and referral networks, within a whole-system approach. Similarly exploration of the three negative propositions helped in the identification of three negative features: (1) misuse of risk-assessment tools for prediction; (2) use of tools in isolation, typically within a ‘scoring’ approach; and (3) development of local tools with little formal validation. Results from the mapping review A total of 49 reports of tools or approaches to assessing the risk of self-harm and suicidality among children or adolescents were identified from the reviews (n = 8) or original studies (n = 41). Our analysis extended the 29 assessment tools included in a previous scoping review (Carter T, Walker GM, Aubeeluck A, Manning JC. Assessment tools of immediate risk of self-harm and suicide in children and young people: a scoping review. J Child Health Care 2019;23:178–99.); adding two recent tools (Manning JC, Walker GM, Carter T, Aubeeluck A, Witchell M, Coad J; The CYP-MH SAT study group. Children and Young People-Mental Health Safety Assessment Tool (CYP-MH SAT) study: protocol for the development and psychometric evaluation of an assessment tool to identify immediate risk of self-harm and suicide in children and young people (10-19 years) in acute paediatric hospital settings. BMJ Open 2018;8:e020964. 20180412; Vrouva I, Fonagy P, Fearon PR, Roussow T. The risk-taking and self-harm inventory for adolescents: development and psychometric evaluation. Psychol Assess 2010;22:852–65.) and expanding beyond formal tools to include overall approaches. We included tools previously included in the scoping review (Carter et al. 2019) where used in a UK context and with a primary focus on suicide. Tools varied in length, response and scoring format, age ranges and degree of psychometric testing (Carter et al. 2019). In particular, tools lacked predictive validity. Most assessments were tested across broad age ranges, and so lack sensitivity to the age groups of particular interest to this review. The relative lack of tools for children, as opposed to adolescents, is noticeable. Tools were subject to limited psychometric testing, and no single tool was valid or reliable for use with children presenting in mental health crisis to non-mental health settings (Carter et al. 2019). Implications for healthcare practice and service delivery A thorough biopsychosocial assessment offers a holistic approach to assessment across many factors including, but not focused upon, risk of self-harm and suicide. Such an assessment requires that service managers identify time for this interaction, particularly for front-line staff. Checklists may help in demonstrating compliance with national standards and protocols but, ultimately, may threaten the relationship between health professional and young person or obscure a full understanding of patient risk. Findings from these reviews confirm recommendations made by NICE guidance with regard to the misuse of risk-assessment tools for prediction of suicide risk and for determining clinical management. Variability in suicidality, even over short periods of time, make suicide risk prediction particularly problematic. Checklist approaches are static, not dynamic, and therefore unlikely to meet the needs for ongoing risk assessment. Attention should focus on improving the quality of the risk-assessment process, perhaps learning from successful training, supervision and quality improvement initiatives. Recommendations for research Further studies evaluating the utility of specific risk-screening tools and instruments are not warranted, although additional evaluations of risk-assessment processes would benefit from further qualitative insights. Such evaluations could provide an accurate picture of what assessment processes are being used and the clinical value ascribed to each component according to the principles of psychosocial assessment. Further research is required to evaluate the value to young persons, health professionals and health services of a complete and holistic assessment, not simply provision of an alternative tool. An evaluated approach to overall assessment could then be used to support safety management decisions across acute paediatric care settings. In particular, health systems and organisational leadership initiatives could benefit from further close examination of how theoretical tensions between risk minimisation and patient-centred care are enacted at a practical and operational level. Trial registration This study is registered as PROSPERO CRD42021276671. Funding This award was funded by the National Institute of Healthcare Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR135079) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 1. See the NIHR Funding and Awards website for further award information.

Background Care homes predominantly care for older people with complex health and care needs, who are at high risk of unplanned hospital admissions. While often necessary, such admissions can be distressing and provide an opportunity cost as well as a financial cost. Objectives Our objective was to update a 2014 evidence review of interventions to reduce unplanned admissions of care home residents. We carried out a systematic review of interventions used in the UK and other high-income countries by synthesising evidence of effects of these interventions on hospital admissions; feasibility and acceptability; costs and value for money; and factors affecting applicability of international evidence to UK settings. Data sources We searched the following databases in December 2021 for studies published since 2014: Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews; Cumulative Index to Nursing and Allied Health Literature; Health Management Information Consortium; Medline; PsycINFO; Science and Social Sciences Citation Indexes; Social Care Online; and Social Service Abstracts. ‘Grey’ literature (January 2022) and citations were searched and reference lists were checked. Methods We included studies of any design reporting interventions delivered in care homes (with or without nursing) or hospitals to reduce unplanned hospital admissions. A taxonomy of interventions was developed from an initial scoping search. Outcomes of interest included measures of effect on unplanned admissions among care home residents; barriers/facilitators to implementation in a UK setting and acceptability to care home residents, their families and staff. Study selection, data extraction and risk of bias assessment were performed by two independent reviewers. We used published frameworks to extract data on intervention characteristics, implementation barriers/facilitators and applicability of international evidence. We performed a narrative synthesis grouped by intervention type and setting. Overall strength of evidence for admission reduction was assessed using a framework based on study design, study numbers and direction of effect. Results We included 124 publications/reports (30 from the UK). Integrated care and quality improvement programmes providing additional support to care homes (e.g. the English Care Homes Vanguard initiatives and hospital-based services in Australia) appeared to reduce unplanned admissions relative to usual care. Simpler training and staff development initiatives showed mixed results, as did interventions aimed at tackling specific problems (e.g. medication review). Advance care planning was key to the success of most quality improvement programmes but do-not-hospitalise orders were problematic. Qualitative research identified tensions affecting decision-making involving paramedics, care home staff and residents/family carers. The best way to reduce end-of-life admissions through access to palliative care was unclear in the face of inconsistent and generally low-quality evidence. Conclusions Effective implementation of interventions at various stages of residents’ care pathways may reduce unplanned admissions. Most interventions are complex and require adaptation to local contexts. Work at the interface between health and social care is key to successful implementation. Limitations Much of the evidence identified was of low quality because of factors such as uncontrolled study designs and small sample size. Meta-analysis was not possible. Future work We identified a need for improved economic evidence and the evaluation of integrated care models of the type delivered by hospital-based teams. Researchers should carefully consider what is realistic in terms of study design and data collection given the current context of extreme pressure on care homes. Study registration This study is registered as PROSPERO database CRD42021289418. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (award number NIHR133884) and will be published in full in Health and Social Care Delivery Research; Vol. 11, No. 18. See the NIHR Journals Library website for further project information. Plain language summary Older people living in care homes often have complex health problems such as dementia and frailty, and they may need to be taken to hospital at short notice. This can lead to them being admitted for further tests and treatment. We know that some of these unplanned hospital admissions might be avoided if health and social care services worked together to meet residents’ needs. We looked for published research on methods (interventions) used in health and social care to reduce these admissions. Interventions could be carried out by care home staff, general practitioners, nurses, paramedics or other specialists individually or in teams. We asked which interventions have been evaluated, how strong is the evidence that they work and how acceptable they are to care home residents, family carers and staff. We also looked for information on how easy or difficult they are to implement and whether they represent good value for money. We included 124 research studies (30 from the UK). We found that integrated care programmes linking care homes with general practitioners and community services can be effective but need time and support (such as extra money and specialist staff) to implement them. Quality improvement programmes and training to improve staff skills may also reduce admissions. For care home residents nearing the end of life, advance care planning and palliative care can ensure that wishes are followed and avoid potentially burdensome admissions to hospital. Hospital-based teams providing ‘outreach’ services to care homes have been evaluated in Australia and could be suitable for UK research. We found limited evidence on interventions involving paramedics and on ‘value for money’. We found many barriers to implementing new services in the UK, particularly staff shortages and high staff turnover, together with care homes closing down or changing ownership. Successful interventions have often been based on existing services and relationships. Scientific summary Background Residents of care homes for older people often have complex health and care needs driven by frailty and dementia and are at high risk of experiencing unplanned hospital admissions. While such admissions may be appropriate, they can be distressing for residents, their families, friends, and care home staff. They can also be costly for the NHS. Unplanned care home admissions may be avoidable if they arise from conditions that can be managed outside the hospital or are triggered by how care is organised in the community. Interventions to reduce unplanned admissions may be implemented at various points in the health and social care system. In 2014, the University of York Centre for Reviews and Dissemination (CRD) published an evidence briefing on the topic for health service commissioners. They categorised interventions under the headings of community geriatrician services, case management, discharge planning, integrated working between primary care and care homes, medicines management, the prevention of delirium and end-of-life care. The review was based predominantly on systematic reviews and the key finding was that ‘there is little good quality comparative evidence to inform strategies for reducing unplanned admissions from care homes’. The authors noted, however, that closer working between healthcare and care home staff, training for care home staff and advance care planning at the end of life all showed promise. This topic was commissioned by the National Institute for Health and Care Research Health and Social Care Delivery Research Programme in 2020 and the need for an update to the CRD review is justified by the substantial volume of new research since 2014. This review updates and extends the CRD review published in 2014. Objectives/research questions The review addresses the following five research questions: What interventions are used in the UK health and social care system to minimise unplanned hospital admissions of care home residents? What candidate interventions, used in other applicable settings, could potentially be used in the UK? What can we learn from research studies and ‘real-world’ evaluations about the effects of such interventions on admissions? What is known about the feasibility of implementing such interventions in routine practice and their acceptability to care home residents, their families and staff? What is known about the costs and value for money associated with these interventions? Methods A broad search for evidence was conducted in December 2021 to identify published and peer-reviewed literature on interventions to reduce unplanned admissions from care homes in the UK and other high-income countries. The search strategy was initially developed on MEDLINE and included thesaurus and free-text terms and relevant synonyms for the population (residents in care homes for older people) and intervention (interventions to reduce unplanned admissions). The search was limited to research published in English from 2014 to December 2021 to reflect developments since the previous review. The National Institute for Health and Care Excellence filter for Organisation for Economic Co-operation and Development countries was used to aid retrieval of studies from UK and other high-income countries. Searches were conducted on the following databases: Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews Cumulative Index to Nursing and Allied Health Literature EMBASE Health Management Information Consortium MEDLINE PsycINFO® (American Psychological Association, Washington, DC, USA) Science and Social Sciences Citation Indexes Social Care Online Social Service Abstracts. Targeted ‘grey’ literature searches were also conducted to identify reports, guidelines and policy in January 2022. Reference checking of all included studies was undertaken and citation searches of the initial included studies. Search results were downloaded to a bibliographic management database (EndNote X9; Clarivate Analytics, Philadelphia, PA, USA) for deduplication and then exported to EPPI-Reviewer Web (EPPI Centre, University College London, London, UK) for coding and analysis. Inclusion criteria for the review were as follows: Population: Residents of care homes for older people with and without nursing. Intervention: Interventions delivered in care homes or hospitals to reduce unplanned admissions. A taxonomy of interventions was developed to classify the interventions which includes quality improvement (QI) programmes, integrated care, training/workforce development, palliative/end-of-life care, advance care planning (ACP), management of specific problems, emergency department interventions, paramedic assessment/non-conveyance and other. Outcomes: Primary outcomes were measures of impact on unplanned admissions among care home residents; barriers/facilitators to implementation in a UK setting and acceptability to care home residents, their families and staff involved in delivering the intervention. Setting: The setting of interest is the UK social care and health system. Studies from other high-income countries (as defined by the World Bank) were included but synthesised separately and assessed for relevance to the UK context. Comparator: Studies will ideally compare an intervention with an alternative (such as continuing current practice) using an experimental or quasi-experimental design. Before/after studies with or without a control setting and non-comparative qualitative or mixed methods studies were also included. Study design: We included any study design that provided data on the outcomes of interest. We also included systematic literature reviews, but in view of the volume of primary literature retrieved, these were used for reference checking only. Study selection was undertaken in stages: Keyword searching of EPPI-Reviewer for relevant terms in title and abstract was used as a preliminary filter to reduce the large number of records retrieved to a more manageable set. A single reviewer excluded records with relevant terms that were clearly not relevant based on the title. Remaining records, titles and abstracts were screened independently by two reviewers. Full-text items that potentially met the inclusion criteria were obtained and evaluated by two reviewers independently with discrepancies resolved by consensus or referral to a third reviewer. Data from included studies were extracted into EPPI-Reviewer using a customised set of codes that covered the study characteristics, key findings/conclusions and strengths/limitations. The Template for Intervention Description and Replication checklist was used to extract data on intervention components and delivery. The Promoting Action on Research Implementation in Health Services framework was used to support extraction of relevant data on implementation of interventions from included UK studies and the Framework for Intervention Transferability Applicability Reporting) tools was used to assess applicability of international evidence to the UK context. Risk of bias for studies using recognised research designs was assessment using the following tools: Joanna Briggs Institute checklists for randomised controlled trials and quasi-experimental studies. National Heart, Lung and Blood Institute checklist for cohort and cross-sectional studies. Mixed Methods Appraisal Tool for mixed methods and qualitative studies. Assessments were performed by two reviewers independently, with discrepancies resolved by consensus or referral to a third reviewer. The review evidence was synthesised narratively. Studies were grouped by type of intervention, using the taxonomy, and setting (UK or international) and the study characteristics, findings and study quality for each group were summarised with any general issues about implementation or applicability to the UK setting. The overall strength of evidence for intervention effectiveness was classified as ‘stronger’, ‘weaker’, ‘very limited’ or ‘inconsistent’. To help decision-makers to form an overall assessment of the value of an intervention, feasibility, applicability and ‘cost-effectiveness’ were considered alongside the evidence on effectiveness. The analysis of the overall strength of the evidence includes all studies included in the review, no studies were excluded based on study design or risk of bias. The main report includes evidence summary tables and detailed tables on intervention characteristics, implementation and applicability and risk of bias tables for different study designs are provided in the appendices. Public involvement Patient and public involvement was an integral part of this review process. A public co-applicant led on public involvement with the support of regular meetings of a public advisory group convened for this review. The review team met with the public advisory group at the start of the project, to discuss emerging findings, for further discussion of review findings and a final meeting focusing on dissemination of the review findings and to discuss their potential involvement in the final report including the plain English and reporting on the public involvement. Results The database search retrieved 16,845 unique references after deduplication. Searches on EPPI-Reviewer were conducted to prioritise references for screening. Screening of the titles of 6141 references by a single reviewer was followed by screening of abstracts of 576 references by two reviewers and full-text screening of 234 potentially relevant records by two reviewers. The citation search and items from the ‘grey’ literature searches were also screened. The review included 124 studies, of which 30 were from the UK, 44 from the USA, 24 from Australia, 4 from New Zealand, 20 from other countries and 2 from multiple countries. Integrated working was the most common type of intervention in the UK and Australia and QI programmes were particularly common in the USA. The review found that integrated care and QI programmes providing additional support to care homes (e.g. the English Care Homes Vanguard initiatives and hospital-based services in Australia) appeared to reduce unplanned admissions relative to usual care. Effective interventions often involved different staff groups, frequently organised in multidisciplinary teams. Simpler training and staff development initiatives showed mixed results, as did interventions aimed at tackling specific problems (e.g. medication review). Advance care planning was key to the success of most QI programmes included in the review but ‘do not hospitalise’ orders were problematic. Qualitative research identified tensions affecting decision-making involving paramedics, care home staff and residents/family carers. The best way to reduce end-of-life admissions through access to palliative care was unclear in the face of inconsistent and generally low-quality evidence. Common barriers to implementation of interventions were high staff turnover, competing pressures on staff time and failure to secure support from care home managers for proposed interventions. Common factors that facilitated successful implementation of interventions were having champions within care homes, funding for implementation of initiatives and a policy environment that prioritises reducing unplanned admissions. We identified a wide range of issues that could affect applicability of international evidence. Examples included mixtures of long-stay and short-stay residents in some nursing homes (USA), cultural attitudes to advanced care planning/palliative care (USA/Europe), workforce regulations and roles of different grades, especially nurses (United States USA/Australia) and public ownership of care homes (the Netherlands/Denmark). Evidence also showed that the cohorts of residents living in care homes are very similar around the globe, suggesting that it is possible to transfer approaches between countries so long as new models from overseas are evaluated in parallel with implementation when introduced for the first time. A total of 11 UK and 14 international studies provided some data on costs or ‘value for money’. Most of these studies were not designed as full economic evaluations, meaning that not all relevant costs and benefits may have been taken into account. The majority of studies reported cost savings, but weak study designs and limited reporting meant that findings should be interpreted with caution. Conclusions Implications for service delivery Opportunities to reduce unplanned admissions exist at all stages of residents’ care journeys from routine care to palliative care at the end of life. Types of intervention such as QI programmes or integrated working between care homes and primary care/community services differ in workforce requirements, technology, intensity of the intervention etc. Services can consider adapting described interventions to their own context, including possibilities for simplification. Evidence suggests that care home managers and staff support proposed interventions that will help them to deliver better care for their residents. Early and genuine consultation to assess feasibility and acceptability of interventions could be a major factor in successfully implementing new service models. Specific work is required to build relationships between NHS and care home providers and staff at a local and regional level. There is some evidence to guide where changes to services are more likely to improve outcomes; for example, care homes without nurses may benefit more than those with nurses from some forms of support because of their lower baseline level of staffing and because of differences in case mix. In attempting to transfer approaches between countries, attention should be paid to the differences and similarities between systems, and new models from overseas should be evaluated in parallel with implementation in the UK setting. Work is needed to better understand and standardise operating procedures between care homes and ambulance providers seeking to negotiate care for residents during medical crises, particularly with regard to lines of responsibility and shared liability for decision-making. Recommendations for research We have identified the following priorities for research: Researchers should carefully consider what is realistic in terms of study design and data collection given the current UK context of extreme pressure on care homes. As with changes to service delivery, genuine involvement of care home residents, family members and staff is required to design and deliver high-quality research. Development and reporting of appropriate patient-reported outcome measures is recommended. Research is needed to understand better the factors that enable effective interventions to become embedded and sustained in practice over the long term. There is a need for rigorous economic evaluations, ideally using measures that can be used to compare different interventions and taking into account costs associated with implementation, particularly how costs are transferred between health and social care commissioners and providers. The national roll-out in England of Hospital at Home, as part of the Frailty Virtual Wards initiative, alongside Urgent Community Response, provides an opportunity to evaluate the applicability of approaches evidenced to work in Australia and in the UK setting. Further research is required to evaluate approaches based on paramedic assessment and potential non-conveyance, including assessment of safety and qualitative studies of resident, family carer and care home staff/management perspectives. Further research is required to better understand the role of telehealth in reducing unplanned admissions of residents with cognitive or sensory impairments. Research to evaluate interventions to reduce unplanned admissions from assisted living settings in the UK is required, bearing in mind the lower levels of both resident need and on-site services. Study registration This study is registered as PROSPERO CRD42021289418. The full protocol can be accessed via https://fundingawards.nihr.ac.uk/award/NIHR133884 (accessed 9 January 2023). Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (award number NIHR133884) and will be published in full in Health and Social Care Delivery Research; Vol. 11, No. 18. See the NIHR Journals Library website for further project information.

Abstract Background Worsening mental health of students in higher education is a public policy concern and the impact of measures to reduce transmission of COVID-19 has heightened awareness of this issue. Preventing poor mental health and supporting positive mental wellbeing needs to be based on an evidence informed understanding what factors influence the mental health of students. Objectives To identify factors associated with mental health of students in higher education. Methods We undertook a systematic review of observational studies that measured factors associated with student mental wellbeing and poor mental health. Extensive searches were undertaken across five databases. We included studies undertaken in the UK and published within the last decade (2010–2020). Due to heterogeneity of factors, and diversity of outcomes used to measure wellbeing and poor mental health the findings were analysed and described narratively. Findings We included 31 studies, most of which were cross sectional in design. Those factors most strongly and consistently associated with increased risk of developing poor mental health included students with experiences of trauma in childhood, those that identify as LGBTQ and students with autism. Factors that promote wellbeing include developing strong and supportive social networks. Students who are prepared and able to adjust to the changes that moving into higher education presents also experience better mental health. Some behaviours that are associated with poor mental health include lack of engagement both with learning and leisure activities and poor mental health literacy. Conclusion Improved knowledge of factors associated with poor mental health and also those that increase mental wellbeing can provide a foundation for designing strategies and specific interventions that can prevent poor mental health and ensuring targeted support is available for students at increased risk.

Abstract Background The term ‘safeguarding’ covers the protection of health, wellbeing and human rights. Effective safeguarding enables people (particularly children, young adults and other vulnerable people) to live free from fear of abuse, harm or neglect. The UK Children Act 2004 required key agencies, including health and social care providers, to consider the need to safeguard children and promote their welfare. Within a larger evidence synthesis project, we sought to identify and map service development interventions (excluding provision of training) aimed at improving awareness of safeguarding and identifying at-risk children and young people in health and social care settings. Methods We searched fourteen health and social care databases from 2004 (date of Children Act) to October 2019 and updated the review via a citation search in March 2021. Studies of any design were eligible if they described or evaluated an intervention (other than training) aimed at health or social care professionals in the United Kingdom and designed to improve recognition of risk in the context of safeguarding children and young people. Studies with no intervention (e.g. qualitative studies) were included to explain why interventions work or fail to work. Included studies were summarised using narrative synthesis. Risk of bias of included studies and overall strength of evidence were assessed using standard methods. We used a 5-item checklist (“TIDieR-Lite”) to map intervention components. Results Thirty-nine publications were included, of which 31 dealt with service developments, six with use of data and two with other initiatives. Promising service development initiatives include liaison nurses, assessment clinics, secondment, joint protocols and a ‘hub and spoke’ model. Initiatives involving use of routine data appeared promising and unlikely to generate significant additional costs. However, the quality of the evidence was generally low, with a shortage of controlled and long-term studies. Conclusions Health and social care services wishing to improve awareness of child safeguarding issues may benefit from looking beyond high-quality training provision. Future research should focus on service-relevant outcomes and ensure the active involvement of young people and their families/carers.

Abstract Background Work, rather than unemployment, is recognised as being good for health, but there may be an age when the benefits are outweighed by adverse impacts. As countries around the world increase their typical retirement age, the potential effect on population health and health inequalities requires scrutiny. Methods We carried out a systematic review of literature published since 2011 from developed countries on the health effects of employment in those over 64 years of age. We completed a narrative synthesis and used harvest plots to map the direction and volume of evidence for the outcomes reported. We followed the Preferred Reporting Items for Systematic Reviews (PRISMA) checklist in our methods and reporting. Results We identified seventeen relevant studies, which were of cohort or cross-sectional design. The results indicate evidence of beneficial or neutral effects from extended working on overall health status and physical health for many employees, and mixed effects on mental health. The benefits reported however, are most likely to be for males, those working part-time or reducing to part-time, and employees in jobs which are not low quality or low reward. Conclusions Extending working life (particularly part time) may have benefits or a neutral effect for some, but adverse effects for others in high demand or low reward jobs. There is the potential for widening health inequalities between those who can choose to reduce their working hours, and those who need to continue working full time for financial reasons. There is a lack of evidence for effects on quality of life, and a dearth of interventions enabling older workers to extend their healthy working life.

Summary: The proportion of adults older than 65 years is rapidly increasing. Care home residents in this age group have disproportionate rates of transfer to the Emergency Department (ED) and around 40% of attendances might be avoidable. We did a systematic review to identify factors that predict ED transfer from care homes. Six electronic databases were searched. Observational studies that provided estimates of association between ED attendance and variables at a resident or care home level were included. 26 primary studies met the inclusion criteria. Seven common domains of factors assessed for association with ED transfer were identified and within these domains, male sex, age, presence of specific comorbidities, polypharmacy, rural location, and care home quality rating were associated with likelihood of ED transfer. The identification of these factors provides useful information for policy makers and researchers intending to either develop interventions to reduce hospitalisations or use adjusted rates of hospitalisation as a care home quality indicator.

Background: Mild cognitive impairment in older adults is a risk factor for dementia. Mild cognitive impairment is a result of a diverse range of underlying causes and may progress to dementia, remain stable or improve over time. Objectives: We aimed to assess the evidence base around the assessment and management pathway of older adults with mild cognitive impairment in community/primary care, hospital and residential settings. Data sources: In January 2021, we searched MEDLINE, EMBASE, PsycInfo®, Scopus, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library (i.e. Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials), Science Citation Index and Social Science Citation Index. The search was limited to studies published in English between 2010 and 2020. Grey literature and citation searches were also performed. Methods: We performed two separate evidence reviews: (1) a descriptive review with narrative synthesis focusing on diagnosis, service provision and patient experience; and (2) a critical interpretive synthesis of evidence on the advantages and disadvantages of ‘mild cognitive impairment’ as a diagnostic label. Results: A total of 122 studies were included in the descriptive review, of which 29 were also included in the critical interpretive synthesis. Study participants were most commonly recruited from populations of community-living older adults or those who had sought medical help from their general practitioner for memory problems. Follow-up searching identified a further 11 studies for the critical interpretive synthesis. The descriptive review identified multiple barriers to efficient diagnosis, starting with patient reluctance to seek help. General practitioners have a variety of cognitive tests available, but substantial numbers of patients meeting criteria for dementia do not have a diagnosis recorded. Patients may be referred to a memory clinic, but these clinics are mainly intended to identify and support people with dementia, and people with mild cognitive impairment may be discharged back to their general practitioner until symptoms worsen. Availability of scanning and biomarker tests is patchy. Qualitative studies show that patients with mild cognitive impairment and their carers find the process of investigation and diagnosis difficult and frustrating to negotiate. The key finding from the critical interpretive synthesis was that the need for a ‘timely’ diagnosis outweighs the ongoing debate about the value, or otherwise, of early investigation and labelling of memory problems. Determining what is a timely diagnosis involves balancing the perspectives of the patient, the health system and the clinician. Conclusions: The two reviews reported here have applied different ‘lenses’ to the same body of evidence. Taken together, the reviews highlight the importance of a timely diagnosis for memory problems and identify barriers to obtaining such a diagnosis, from reluctance to seek help through to patchy availability of advanced diagnostic tests. Limitations: The review was primarily descriptive, reflecting the prespecified review questions. Study selection was complicated by lack of a consistent definition of mild cognitive impairment and its overlap with other memory disorders. It was not possible to employ double study selection, data extraction or quality assessment, although processes of checking and verification were used throughout the review. Future work: Priorities include evaluating remote methods of memory assessment and preparing for the likely future availability of disease-modifying treatments for early dementia. Research is needed on the investigation of memory problems in hospital and social care settings. Study registration: This study is registered as PROSPERO CRD42021232535. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 10. See the NIHR Journals Library website for further project information.

Abstract Background Reconfiguration of urgent and emergency care services often increases travel time/distance for patients to reach an appropriate facility. Evidence of the effects of reconfiguration is important for local communities and commissioners and providers of health services. Methods We performed a systematic review of the evidence regarding effects of service reconfigurations that increase the time/distance for some patients to reach an urgent and emergency care (UEC) facility. We searched seven bibliographic databases from 2000 to February 2019 and used citation tracking and reference lists to identify additional studies. We included studies of any design that compared outcomes for people with conditions requiring emergency treatment before and after service reconfiguration with an associated change in travel time/distance to access UEC. Studies had to be conducted in the UK or other developed countries. Data extraction and quality assessment (using the Joanna Briggs Institute checklist for quasi-experimental studies) were undertaken by a single reviewer with a sample checked for accuracy and consistency. We performed a narrative synthesis of the included studies. Overall strength of evidence was assessed using a previously published method that considers volume, quality and consistency. Results We included 12 studies, of which six were conducted in the USA, two in the UK and four in other European countries. The studies used a variety of observational designs, with before–after and cohort designs being most common. Only two studies included an independent control site/sites where no reconfiguration had taken place. The reconfigurations evaluated in these studies reported relatively small effects on average travel times/distance. Discussion For studies of general UEC populations, there was no convincing evidence as to whether reconfiguration affected mortality risk. However, evidence of increased risk was identified from studies of patients with acute myocardial infarction, particularly 1 to 4 years after reconfiguration. Evidence for other conditions was inconsistent or very limited. Conclusions We found insufficient evidence to determine whether increased distance to UEC increases mortality risk for the general population of people requiring UEC, although this conclusion may not extend to people with specific conditions.

Background: The first histology-independent marketing authorisation in Europe was granted in 2019. This was the first time that a cancer treatment was approved based on a common biomarker rather than the location in the body at which the tumour originated. This research aims to explore the implications for National Institute for Health and Care Excellence appraisals. Methods: Targeted reviews were undertaken to determine the type of evidence that is likely to be available at the point of marketing authorisation and the analyses required to support National Institute for Health and Care Excellence appraisals. Several challenges were identified concerning the design and conduct of trials for histology-independent products, the greater levels of heterogeneity within the licensed population and the use of surrogate end points. We identified approaches to address these challenges by reviewing key statistical literature that focuses on the design and analysis of histology-independent trials and by undertaking a systematic review to evaluate the use of response end points as surrogate outcomes for survival end points. We developed a decision framework to help to inform approval and research policies for histology-independent products. The framework explored the uncertainties and risks associated with different approval policies, including the role of further data collection, pricing schemes and stratified decision-making. Results: We found that the potential for heterogeneity in treatment effects, across tumour types or other characteristics, is likely to be a central issue for National Institute for Health and Care Excellence appraisals. Bayesian hierarchical methods may serve as a useful vehicle to assess the level of heterogeneity across tumours and to estimate the pooled treatment effects for each tumour, which can inform whether or not the assumption of homogeneity is reasonable. Our review suggests that response end points may not be reliable surrogates for survival end points. However, a surrogate-based modelling approach, which captures all relevant uncertainty, may be preferable to the use of immature survival data. Several additional sources of heterogeneity were identified as presenting potential challenges to National Institute for Health and Care Excellence appraisal, including the cost of testing, baseline risk, quality of life and routine management costs. We concluded that a range of alternative approaches will be required to address different sources of heterogeneity to support National Institute for Health and Care Excellence appraisals. An exemplar case study was developed to illustrate the nature of the assessments that may be required. Conclusions: Adequately designed and analysed basket studies that assess the homogeneity of outcomes and allow borrowing of information across baskets, where appropriate, are recommended. Where there is evidence of heterogeneity in treatment effects and estimates of cost-effectiveness, consideration should be given to optimised recommendations. Routine presentation of the scale of the consequences of heterogeneity and decision uncertainty may provide an important additional approach to the assessments specified in the current National Institute for Health and Care Excellence methods guide. Further research: Further exploration of Bayesian hierarchical methods could help to inform decision-makers on whether or not there is sufficient evidence of homogeneity to support pooled analyses. Further research is also required to determine the appropriate basis for apportioning genomic testing costs where there are multiple targets and to address the challenges of uncontrolled Phase II studies, including the role and use of surrogate end points. Funding: This project was funded by the National Institute for Health Research (NIHR) Evidence Synthesis programme and will be published in full in Health Technology Assessment; Vol. 25, No. 76. See the NIHR Journals Library website for further project information.

Background: For systematic reviews to be rigorous, deliverable and useful, they need a well-defined review question. Scoping for a review also requires the specification of clear inclusion criteria and planned synthesis methods. Guidance is lacking on how to develop these, especially in the context of undertaking rapid and responsive systematic reviews to inform health services and health policy. Objective: This report describes and discusses the experiences of review scoping of three commissioned research centres that conducted evidence syntheses to inform health and social care organisation, delivery and policy in the UK, between 2017 and 2020. Data sources: Sources included researcher recollection, project meeting minutes, e-mail correspondence with stakeholders and scoping searches, from allocation of a review topic through to review protocol agreement. Methods: We produced eight descriptive case studies of selected reviews from the three teams. From case studies, we identified key issues that shape the processes of scoping and question formulation for evidence synthesis. The issues were then discussed and lessons drawn. Findings: Across the eight diverse case studies, we identified 14 recurrent issues that were important in shaping the scoping processes and formulating a review’s questions. There were ‘consultative issues’ that related to securing input from review commissioners, policy customers, experts, patients and other stakeholders. These included managing and deciding priorities, reconciling different priorities/perspectives, achieving buy-in and engagement, educating the end-user about synthesis processes and products, and managing stakeholder expectations. There were ‘interface issues’ that related to the interaction between the review team and potential review users. These included identifying the niche/gap and optimising value, assuring and balancing rigour/reliability/relevance, and assuring the transferability/applicability of study evidence to specific policy/service user contexts. There were also ‘technical issues’ that were associated with the methods and conduct of the review. These were choosing the method(s) of synthesis, balancing fixed and fluid review questions/components/definitions, taking stock of what research already exists, mapping versus scoping versus reviewing, scoping/relevance as a continuous process and not just an initial stage, and calibrating general compared with specific and broad compared with deep coverage of topics. Limitations: As a retrospective joint reflection by review teams on their experiences of scoping processes, this report is not based on prospectively collected research data. In addition, our evaluations were not externally validated by, for example, policy and service evidence users or patients and the public. Conclusions: We have summarised our reflections on scoping from this programme of reviews as 14 common issues and 28 practical ‘lessons learned’. Effective scoping of rapid, responsive reviews extends beyond information exchange and technical procedures for specifying a ‘gap’ in the evidence. These considerations work alongside social processes, in particular the building of relationships and shared understanding between reviewers, research commissioners and potential review users that may be reflective of consultancy, negotiation and co-production models of research and information use. Funding: This report has been based on work commissioned by the National Institute for Health Research (NIHR) Health Services and Delivery Research (HSDR) programme as three university-based evidence synthesis centres to inform the organisation, delivery and commissioning of health and social care; at the University of Exeter (NIHR 16/47/22), the University of Sheffield (NIHR 16/47/17) and the University of York (NIHR 16/47/11). This report was commissioned by the NIHR HSDR programme as a review project (NIHR132708) within the NIHR HSDR programme. This project was funded by the NIHR HSDR programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 15. See the NIHR Journals Library website for further project information.

Background: Service reconfigurations sometimes increase travel time and/or distance for patients to reach their nearest hospital or other urgent and emergency care facility. Many communities value their local services and perceive that proposed changes could worsen outcomes for patients. Objectives: To identify, appraise and synthesise existing research evidence regarding the outcomes and impacts of service reconfigurations that increase the time and/or distance for patients to reach an urgent and emergency care facility. We also aimed to examine the available evidence regarding associations between distance to a facility and outcomes for patients and health services, together with factors that may influence (moderate or mediate) these associations. Data sources: We searched seven bibliographic databases in February 2019. The search was supplemented by citation-tracking and reference list checking. A separate search was conducted to identify the current systematic reviews of telehealth to support urgent and emergency care. Methods: Brief inclusion and exclusion criteria were as follows: (1) population – adults or children with conditions that required emergency treatment; (2) intervention/comparison – studies comparing outcomes before and after a service reconfiguration, which affects the time/distance to urgent and emergency care or comparing outcomes in groups of people travelling different distances to access urgent and emergency care; (3) outcomes – any patient or health system outcome; (4) setting – the UK and other developed countries with relevant health-care systems; and (5) study design – any. The search results were screened against the inclusion criteria by one reviewer, with a 10% sample screened by a second reviewer. A quality (risk-of-bias) assessment was undertaken using The Joanna Briggs Institute Checklist for Quasi-Experimental Studies. We performed a narrative synthesis of the included studies and assessed the overall strength of evidence using a previously published method. Results: We included 44 studies in the review, of which eight originated from the UK. For studies of general urgent and emergency care populations, there was no evidence that reconfiguration that resulted in increased travel time/distance affected mortality rates. By contrast, evidence of increased risk was identified from studies restricted to patients with acute myocardial infarction. Increases in mortality risk were most obvious within the first 1–4 years after reconfiguration. Evidence for other conditions was inconsistent or very limited. In the absence of reconfiguration, evidence mainly from cohort studies indicated that increased travel time or distance is associated with increased mortality risk for the acute myocardial infarction and trauma populations, whereas for obstetric emergencies the evidence was inconsistent. We included 12 systematic reviews of telehealth. Meta-analyses suggested that telehealth technologies can reduce time to treatment for people with stroke and ST elevation myocardial infarction. Limitations: Most studies came from non-UK settings and many were at high risk of bias because there was no true control group. Most review processes were carried out by a single reviewer within a constrained time frame. Conclusions: We found no evidence that increased distance increases mortality risk for the general population of people requiring urgent and emergency care, although this may not be true for people with acute myocardial infarction or trauma. Increases in mortality risk were most likely in the first few years after reconfiguration. Future work: Research is needed to better understand how health systems plan for and adapt to increases in travel time, to quantify impacts on health system outcomes, and to address the uncertainty about how risk increases with distance in circumstances relevant to UK settings. Study registration: This study is registered as PROSPERO CRD42019123061. Funding: This project was funded by the NIHR Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 31. See the NIHR Journals Library website for further project information.

Background: The term ‘safeguarding’ refers to measures designed to protect health, wellbeing and human rights, allowing people (especially children, young people and vulnerable adults) to live without fear of abuse, harm or neglect. The Children Act 2004 placed a responsibility on key agencies, including those in health and social care, to have regard to the need to safeguard children and promote their welfare. Objectives: To address the question ‘What interventions are feasible/acceptable, effective and cost effective in: Data sources: Fourteen health and social care databases were searched from 2004 (date of Children Act) to October 2019. Methods: This mapping review included an extensive literature search, independent study selection, extraction of study data and quality assessment of study design features. The research was carried out in two stages. We systematically retrieved and coded UK research and policy documents to gain a contemporary picture of safeguarding issues and practice. We also identified systematic reviews or narrative reviews that reported safeguarding practice from other high-income countries. Studies were summarised using narrative synthesis in four pre-defined groupings. A further grouping of policy/guidance documents was added based on examination of the evidence retrieved. Results: The review included 179 papers (Strategies=15; Policy/Guidance=36; Cultural/Organisational=31; Initiatives=69 and Reviews=28). There were four empirical evaluations of strategies (‘what to do’) and 54 of initiatives (‘how to do it’). Most initiatives fell into three categories: training, service development and use of data. Promising initiatives included liaison nurses; assessment clinics; secondment; joint protocols; and a ‘hub and spoke’ model. Approaches using routinely collected data also appeared promising. However, the evidence base comprised mainly cross-sectional or before/after studies with no control group, providing little hard evidence of effectiveness. Barriers to effective implementation of safeguarding strategies were identified at all levels of the health and care system. Limitations: We used a number of methods to abbreviate the review process. Limitations of the evidence base included lack of long-term follow-up, control groups and data on service-relevant outcomes. Conclusions: The UK and international literature documents increased awareness and activity in relation to safeguarding. A limited number of types of interventions have been reported and generally these lack rigorous evaluation. In particular, the user voice is muted in relation to experience of different interventions or services. Taken as a whole the topic of child safeguarding seems to be lacking a whole system approach which would facilitate a more joined-up approach. Future work: Future research questions centre on the need to balance multi-agency training and development initiatives with the specific needs of individual health and social care professional groups. Funding: NIHR Health Services & Delivery Research Programme (project number HSDR16/47/17).

Background: In 2015, approximately 2.16% of adults were recorded as having intellectual disabilities. UK government policy is that adults with intellectual disabilities should access mainstream health services. However, people with intellectual disabilities experience challenges when accessing primary and community health services that can lead to inequalities and shorter life expectancy. Objectives: To map and review the evidence on access to primary and community health-care services for adults with intellectual disabilities and their carers. To identify influencing factors for gaining access to primary and community health-care services. To determine which actions, interventions or models of service provision improve entry access to these services for people with intellectual disabilities and their carers. Finally, to identify the gaps in evidence and provide implications for health care and recommendations for research. Data sources: MEDLINE, The Cochrane Library, Web of Science, Cumulative Index of Nursing and Allied Health Literature (CINAHL), Applied Social Sciences Index and Abstracts (ASSIA) and Education Resources Information Center (ERIC) were searched from 2002 to 2018. Review methods: The mapping review methodology included an extensive literature search, article selection and data extraction of relevant abstracts. Findings from the mapping review informed the scope of the targeted systematic review. Methodology for the targeted systematic review included an extensive literature search informed by the mapping review, article selection, data extraction, quality appraisal and narrative synthesis. Results: The mapping review included 413 studies with data extraction completed on abstracts. The targeted systematic review synthesised the evidence from 80 studies reported in 82 publications. During the review process, the team identified three key points at which people with intellectual disabilities potentially interacted with primary and community health-care services: identifying needs, accessing services and interaction during a consultation. In addition, there were a number of papers about interventions or innovations to improve access. Evidence from the studies was synthesised within the four clusters. Influencing factors were identified: staff knowledge/skills, joint working with learning disability services, service delivery model, uptake, appointment making, carer/support role, relationship with staff, time, accessible information and communication. The influencing factors were cross-cutting through the literature, with certain factors having more importance in certain clusters. Limitations: The main limitation was the weak evidence base. The studies generally had small samples, had study designs that were open to potential biases and measured only short-term outcomes. Conclusions: Health checks were found to help identify health needs and improve the care of long-term conditions. Important factors for accessing health services for adults with intellectual disabilities were consistency of care and support, staff training, communication skills and time to communicate, and provision of accessible information. Health professionals need to ensure that there is joint working between different services, clear communication and accurate record-keeping. Future research questions centre on the need to develop and value creative study designs capable of addressing the complex issues identified in the findings of the review for this complex 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. 8, No. 5. See the NIHR Journals Library website for further project information.

Background: In 2012, a series of systematic reviews summarised the evidence regarding interventions to reduce preventable hospital admissions. Although intervention effects were dependent on context, the reviews revealed a consistent picture of reduction across different interventions targeting cardiovascular and respiratory conditions. The research reported here sought to provide an in-depth understanding of how interventions that have been shown to reduce admissions for these conditions may work, with a view to supporting their effective implementation in practice. Objectives: To map the available evidence on interventions used in the UK NHS to reduce preventable admissions for cardiovascular and respiratory conditions and to conduct a realist synthesis of implementation evidence related to these interventions. Methods: For the mapping review, six databases were searched for studies published between 2010 and October 2017. Studies were included if they were conducted in the UK, the USA, Canada, Australia or New Zealand; recruited adults with a cardiovascular or respiratory condition; and evaluated or described an intervention that could reduce preventable admissions or re-admissions. A descriptive summary of key characteristics of the included studies was produced. The studies included in the mapping review helped to inform the sampling frame for the subsequent realist synthesis. The wider evidence base was also engaged through supplementary searching. Data extraction forms were developed using appropriate frameworks (an implementation framework, an intervention template and a realist logic template). Following identification of initial programme theories (from the theoretical literature, empirical studies and insights from the patient and public involvement group), the review team extracted data into evidence tables. Programme theories were examined against the individual intervention types and collectively as a set. The resultant hypotheses functioned as synthesised statements around which an explanatory narrative referenced to the underpinning evidence base was developed. Additional searches for mid-range and overarching theories were carried out using Google Scholar (Google Inc., Mountain View, CA, USA). Results: A total of 569 publications were included in the mapping review. The largest group originated from the USA. The included studies from the UK showed a similar distribution to that of the map as a whole, but there was evidence of some country-specific features, such as the prominence of studies of telehealth. In the realist synthesis, it was found that interventions with strong evidence of effectiveness overall had not necessarily demonstrated effectiveness in UK settings. This could be a barrier to using these interventions in the NHS. Facilitation of the implementation of interventions was often not reported or inadequately reported. Many of the interventions were diverse in the ways in which they were delivered. There was also considerable overlap in the content of interventions. The role of specialist nurses was highlighted in several studies. The five programme theories identified were supported to varying degrees by empirical literature, but all provided valuable insights. Limitations: The research was conducted by a small team; time and resources limited the team’s ability to consult with a full range of stakeholders. Conclusions: Overall, implementation appears to be favoured by support for self-management by patients and their families/carers, support for services that signpost patients to consider alternatives to seeing their general practitioner when appropriate, recognition of possible reasons why patients seek admission, support for health-care professionals to diagnose and refer patients appropriately and support for workforce roles that promote continuity of care and co-ordination between services. Future work: Research should focus on understanding discrepancies between national and international evidence and the transferability of findings between different contexts; the design and evaluation of implementation strategies informed by theories about how the intervention being implemented might work; and qualitative research on decision-making around hospital referrals and admissions. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

Background: Digital and online symptom checkers and assessment services are used by patients seeking guidance about health problems. NHS England is planning to introduce a digital platform (NHS111 Online) to operate alongside the NHS111 urgent-care telephone service. This review focuses on digital and online symptom checkers for urgent health problems. Objectives: This systematic review was commissioned to provide NHS England with an independent review of previous research in this area to inform strategic decision-making and service design. Data sources: Focused searches of seven bibliographic databases were performed and supplemented by phrase searching for names of symptom checker systems and citation searches of key included studies. The bibliographic databases searched were MEDLINE, EMBASE, The Cochrane Library, CINAHL (Cumulative Index to Nursing and Allied Health Literature), HMIC (Health Management Information Consortium), Web of Science and the Association of Computing Machinery (ACM) Digital Library, from inception up to April 2018. Review methods: Brief inclusion criteria were (1) population – general population seeking information online or digitally to address an urgent health problem; (2) intervention – any online or digital service designed to assess symptoms, provide health advice and direct patients to appropriate services; and (3) comparator – telephone or face-to-face assessment, comparative performance in tests or simulations (studies with no comparator were included if they reported relevant outcomes). Outcomes of interest included safety, clinical effectiveness, costs or cost-effectiveness, diagnostic and triage accuracy, use of and contacts with health services, compliance with advice received, patient/carer satisfaction, and equity and inclusion. Inclusion was not restricted by study design. Screening studies for inclusion, data extraction and quality assessment were carried out by one reviewer with a sample checked for accuracy and consistency. Final decisions on study inclusion were taken by consensus of the review team. A narrative synthesis of the included studies was performed and structured around the predefined research questions and key outcomes. The overall strength of evidence for each outcome was classified as ‘stronger’, ‘weaker’, ‘conflicting’ or ‘insufficient’, based on study numbers and design. Results: In total, 29 publications describing 27 studies were included. Studies were diverse in their design and methodology. The overall strength of the evidence was weak because it was largely based on observational studies and with a substantial component of non-peer-reviewed grey literature. There was little evidence to suggest that symptom checkers are unsafe, but studies evaluating their safety were generally short term and small scale. Diagnostic accuracy was highly variable between different systems but was generally low. Algorithm-based triage tended to be more risk averse than that of health professionals. Inconsistent evidence was found on effects on service use. There was very limited evidence on patients’ reactions to online triage advice. The studies showed that younger and more highly educated people are more likely to use these services. Study participants generally expressed high levels of satisfaction with digital and online triage services, albeit in uncontrolled studies. Limitations: Findings from symptom checker systems for specific conditions may not be applicable to more general systems and vice versa. Studies of symptom checkers as part of electronic consultation systems in general practice were also included, which is a slightly different setting from a general ‘digital 111’ service. Most studies were screened by one reviewer. Conclusions: Major uncertainties surround the probable impact of digital 111 services on most outcomes. It will be important to monitor and evaluate the services using all available data sources and by commissioning high-quality research. Future work: Priorities for research include comparisons of different systems, rigorous economic evaluations and investigations of patient pathways. Study registration: The study is registered as PROSPERO CRD42018093564. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

Background: Emergency departments (EDs) are facing unprecedented levels of demand. One of the causes of this increased demand is the ageing population. Older people represent a particular challenge to the ED as those older people who are frail will require management that considers their frailty alongside their presenting complaint. How to identify these older people as frail and how best to manage them in the ED is a major challenge for the health service to address. Objectives: To systematically map interventions to identify frail and high-risk older people in the ED and interventions to manage older people in the ED and to map the outcomes of these interventions and examine whether or not there is any evidence of the impact of these interventions on patient and health service outcomes. Design: A systematic mapping review. Setting: Evidence from developed countries on interventions delivered in the ED. Participants: Frail and high-risk older people and general populations of older people (aged > 65 years). Interventions: Interventions to identify older people who are frail or who are at high risk of adverse outcomes and to manage (frail) older people within the ED. Main outcome measures: Patient outcomes (direct and indirect) and health service outcomes. Data sources: Evidence from 103 peer-reviewed articles and conference abstracts and 17 systematic reviews published from 2005 to 2016. Review methods: A review protocol was drawn up and a systematic database search was undertaken for the years 2005–2016 (using MEDLINE, EMBASE, The Cochrane Library, Web of Science, Cumulative Index to Nursing and Allied Health Literature, Health Management Information Consortium and PROSPERO). Studies were included according to predefined criteria. Following data extraction, evidence was classified into interventions relating to the identification of frail/high-risk older people in the ED and interventions relating to their management. A narrative synthesis of interventions/outcomes relating to these categories was undertaken. A quality assessment of individual studies was not undertaken; instead, an assessment of the overall evidence base in this area was made. Results: Of the 90 included studies, 32 focused on a frail/high-risk population and 60 focused on an older population. These studies reported on interventions to identify (n = 57) and manage (n = 53) older people. The interventions to identify frail and at-risk older people, on admission and at discharge, utilised a number of different tools. There was extensive evidence on these question-based tools, but the evidence was inconclusive and contradictory. Service delivery innovations comprised changes to staffing, infrastructure and care delivery. There was a general trend towards improved outcomes in admissions avoidance, reduced ED reattendance and improved discharge outcomes. Limitations: This review was a systematic mapping review. Some of the methods adopted differed from those used in a standard systematic review. Mapping the evidence base has led to the inclusion of a wide variety of evidence (in terms of study type and reporting quality). No recommendations on the effectiveness of specific interventions have been made as this was outside the scope of the review. Conclusions: A substantial body of evidence on interventions for frail and high-risk older people was identified and mapped. Future work: Future work in this area needs to determine why interventions work and whether or not they are feasible for the NHS and acceptable to patients. Study registration: This study is registered as PROSPERO CRD42016043260. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

Introduction: Premature ejaculation (PE) is defined by short ejaculatory latency and inability to delay ejaculation causing distress. Management may involve behavioral and/or pharmacological approaches. Aim: To systematically review the randomized controlled trial (RCT) evidence for behavioral therapies in the management of PE. Methods: Nine databases including MEDLINE were searched up to August 2014. Included RCTs compared behavioral therapy against waitlist control or another therapy, or behavioral plus drug therapy against drug treatment alone. [Correction added on 10 September 2015, after first online publication: Search period has been amended from August 2013 to August 2014.] Main Outcome Measure: Intravaginal ejaculatory latency time (IELT), sexual satisfaction, ejaculatory control, and anxiety and adverse effects. Results: Ten RCTs (521 participants) were included. Overall risk of bias was unclear. All studies assessed physical techniques, including squeeze and stop‐start, sensate focus, stimulation device, and pelvic floor rehabilitation. Only one RCT included a psychotherapeutic approach (combined with stop‐start and drug treatment). Four trials compared behavioral therapies against waitlist control, of which two (involving squeeze, stop‐start, and sensate focus) reported IELT differences of 7–9 minutes, whereas two (web‐based sensate focus, stimulation device) reported no difference in ejaculatory latency posttreatment. For other outcomes (sexual satisfaction, desire, and self‐confidence), some waitlist comparisons significantly favored behavioral therapy, whereas others were not significant. Three trials favored combined behavioral and drug treatment over drug treatment alone, with small but significant differences in IELT (0.5–1 minute) and significantly better results on other outcomes (sexual satisfaction, ejaculatory control, and anxiety). Direct comparisons of behavioral therapy vs. drug treatment gave mixed results, mostly either favoring drug treatment or showing no significant difference. No adverse effects were reported, though safety data were limited. Conclusions: There is limited evidence that physical behavioral techniques for PE improve IELT and other outcomes over waitlist and that behavioral therapies combined with drug treatments give better outcomes than drug treatments alone. Further RCTs are required to assess psychotherapeutic approaches to PE. Cooper K, Martyn‐St James M, Kaltenthaler E, Dickinson K, Cantrell A, Wylie K, Frodsham L, and Hood C. Behavioral therapies for management of premature ejaculation: A systematic review. Sex Med 2015;3:174–188.

Introduction: Premature ejaculation (PE) is defined as ejaculation within 1 minute (lifelong PE) or 3 minutes (acquired PE), inability to delay ejaculation, and negative personal consequences. Management includes behavioral and pharmacologic approaches. Aim: To systematically review effectiveness, safety, and robustness of evidence for complementary and alternative medicine in managing PE. Methods: Nine databases including Medline were searched through September 2015. Randomized controlled trials evaluating complementary and alternative medicine for PE were included. Main Outcome Measures: Studies were included if they reported on intravaginal ejaculatory latency time (IELT) and/or another validated PE measurement. Adverse effects were summarized. Results: Ten randomized controlled trials were included. Two assessed acupuncture, five assessed Chinese herbal medicine, one assessed Ayurvedic herbal medicine, and two assessed topical “severance secret” cream. Risk of bias was unclear in all studies because of unclear allocation concealment or blinding, and only five studies reported stopwatch-measured IELT. Acupuncture slightly increased IELT over placebo in one study (mean difference [MD] = 0.55 minute, P = .001). In another study, Ayurvedic herbal medicine slightly increased IELT over placebo (MD = 0.80 minute, P = .001). Topical severance secret cream increased IELT over placebo in two studies (MD = 8.60 minutes, P < .001), although inclusion criteria were broad (IELT < 3 minutes). Three studies comparing Chinese herbal medicine with selective serotonin reuptake inhibitors (SSRIs) favored SSRIs (MD = 1.01 minutes, P = .02). However, combination treatment with Chinese medicine plus SSRIs improved IELT over SSRIs alone (two studies; MD = 1.92 minutes, P < .00001) and over Chinese medicine alone (two studies; MD = 2.52 minutes, P < .00001). Adverse effects were not consistently assessed but where reported were generally mild. Conclusion: There is preliminary evidence for the effectiveness of acupuncture, Chinese herbal medicine, Ayurvedic herbal medicine, and topical severance secret cream in improving IELT and other outcomes. However, results are based on clinically heterogeneous studies of unclear quality. There are sparse data on adverse effects or potential for drug interactions. Further well-conducted randomized controlled trials would be valuable.

This systematic review evaluated evidence for two dry powder formulations, colistimethate sodium and tobramycin, for the treatment of chronic Pseudomonas aeruginosa in cystic fibrosis, as part of the UK national recommendation process for new technologies. Electronic bibliographic databases were searched in May 2012 (MEDLINE, MEDLINE in-Process, EMBASE, Cochrane Library databases, CINAHL, Web of Science, Conference Proceedings Citation Index and BIOSIS Previews). Relevant outcomes included rate and extent of microbial response (e.g. sputum density of P. aeruginosa), lung function (e.g. forced expiratory volume in 1 s (FEV1)), frequency, severity of acute exacerbations and adverse events. Three trials were included, and both dry powder formulations were reported to be non-inferior in the short term to nebulised tobramycin for FEV1. However, long-term follow-up data were missing and the effect on exacerbation rates was not always reported. Whilst short-term results showed that both dry powder drugs were non-inferior to nebulised tobramycin, there was no long-term follow-up and no phase 3 trials compared nebulised and dry powder colistimethate sodium. The use of FEV1 as the primary end-point may not accurately represent changes in lung health. This review illustrates the difficulty in assessing new technologies where the evidence base is poor.

Background: Ulcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. UC can have a considerable impact on patients’ quality of life. The burden for the NHS is substantial. Objectives: To evaluate the clinical effectiveness and safety of interventions, to evaluate the incremental cost-effectiveness of all interventions and comparators (including medical and surgical options), to estimate the expected net budget impact of each intervention, and to identify key research priorities. Data sources: Peer-reviewed publications, European Public Assessment Reports and manufacturers’ submissions. The following databases were searched from inception to December 2013 for clinical effectiveness searches and from inception to January 2014 for cost-effectiveness searches for published and unpublished research evidence: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and NHS Economic Evaluation Database; ISI Web of Science, including Science Citation Index, and the Conference Proceedings Citation Index-Science and Bioscience Information Service Previews. The US Food and Drug Administration website and the European Medicines Agency website were also searched, as were research registers, conference proceedings and key journals. Review methods: A systematic review [including network meta-analysis (NMA)] was conducted to evaluate the clinical effectiveness and safety of named interventions. The health economic analysis included a review of published economic evaluations and the development of a de novo model. Results: Ten randomised controlled trials were included in the systematic review. The trials suggest that adult patients receiving infliximab (IFX) [Remicade®, Merck Sharp & Dohme Ltd (MSD)], adalimumab (ADA) (Humira®, AbbVie) or golimumab (GOL) (Simponi®, MSD) were more likely to achieve clinical response and remission than those receiving placebo (PBO). Hospitalisation data were limited, but suggested more favourable outcomes for ADA- and IFX-treated patients. Data on the use of surgical intervention were sparse, with a potential benefit for intervention-treated patients. Data were available from one trial to support the use of IFX in paediatric patients. Safety issues identified included serious infections, malignancies and administration site reactions. Based on the NMA, in the induction phase, all biological treatments were associated with statistically significant beneficial effects relative to PBO, with the greatest effect associated with IFX. For patients in response following induction, all treatments except ADA and GOL 100 mg at 32–52 weeks were associated with beneficial effects when compared with PBO, although these were not significant. The greatest effects at 8–32 and 32–52 weeks were associated with 100 mg of GOL and 5 mg/kg of IFX, respectively. For patients in remission following induction, all treatments except ADA at 8–32 weeks and GOL 50 mg at 32–52 weeks were associated with beneficial effects when compared with PBO, although only the effect of ADA at 32–52 weeks was significant. The greatest effects were associated with GOL (at 8–32 weeks) and ADA (at 32–52 weeks). The economic analysis suggests that colectomy is expected to dominate drug therapies, but for some patients, colectomy may not be considered acceptable. In circumstances in which only drug options are considered, IFX and GOL are expected to be ruled out because of dominance, while the incremental cost-effectiveness ratio for ADA versus conventional treatment is approximately £50,300 per QALY gained. Limitations: The health economic model is subject to several limitations: uncertainty associated with extrapolating trial data over a lifetime horizon, the model does not consider explicit sequential pathways of non-biological treatments, and evidence relating to complications of colectomy was identified through consideration of approaches used within previous models rather than a full systematic review. Conclusions: Adult patients receiving IFX, ADA or GOL were more likely to achieve clinical response and remission than those receiving PBO. Further data are required to conclusively demonstrate the effect of interventions on hospitalisation and surgical outcomes. The economic analysis indicates that colectomy is expected to dominate medical treatments for moderate to severe UC. Study registration: This study is registered as PROSPERO CRD42013006883. Funding: The National Institute for Health Research Health Technology Assessment programme.

Background: Postnatal depression (PND) is a major depressive disorder in the year following childbirth, which impacts on women, their infants and their families. A range of interventions has been developed to prevent PND. Objectives: To (1) evaluate the clinical effectiveness, cost-effectiveness, acceptability and safety of antenatal and postnatal interventions for pregnant and postnatal women to prevent PND; (2) apply rigorous methods of systematic reviewing of quantitative and qualitative studies, evidence synthesis and decision-analytic modelling to evaluate the preventive impact on women, their infants and their families; and (3) estimate cost-effectiveness. Data sources: We searched MEDLINE, EMBASE, Science Citation Index and other databases (from inception to July 2013) in December 2012, and we were updated by electronic alerts until July 2013. Review methods: Two reviewers independently screened titles and abstracts with consensus agreement. We undertook quality assessment. All universal, selective and indicated preventive interventions for pregnant women and women in the first 6 postnatal weeks were included. All outcomes were included, focusing on the Edinburgh Postnatal Depression Scale (EPDS), diagnostic instruments and infant outcomes. The quantitative evidence was synthesised using network meta-analyses (NMAs). A mathematical model was constructed to explore the cost-effectiveness of interventions contained within the NMA for EPDS values. Results: From 3072 records identified, 122 papers (86 trials) were included in the quantitative review. From 2152 records, 56 papers (44 studies) were included in the qualitative review. The results were inconclusive. The most beneficial interventions appeared to be midwifery redesigned postnatal care [as shown by the mean 12-month EPDS score difference of –1.43 (95% credible interval –4.00 to 1.36)], person-centred approach (PCA)-based and cognitive–behavioural therapy (CBT)-based intervention (universal), interpersonal psychotherapy (IPT)-based intervention and education on preparing for parenting (selective), promoting parent–infant interaction, peer support, IPT-based intervention and PCA-based and CBT-based intervention (indicated). Women valued seeing the same health worker, the involvement of partners and access to several visits from a midwife or health visitor trained in person-centred or cognitive–behavioural approaches. The most cost-effective interventions were estimated to be midwifery redesigned postnatal care (universal), PCA-based intervention (indicated) and IPT-based intervention in the sensitivity analysis (indicated), although there was considerable uncertainty. Expected value of partial perfect information (EVPPI) for efficacy data was in excess of £150M for each population. Given the EVPPI values, future trials assessing the relative efficacies of promising interventions appears to represent value for money. Limitations: In the NMAs, some trials were omitted because they could not be connected to the main network of evidence or did not provide EPDS scores. This may have introduced reporting or selection bias. No adjustment was made for the lack of quality of some trials. Although we appraised a very large number of studies, much of the evidence was inconclusive. Conclusions: Interventions warrant replication within randomised controlled trials (RCTs). Several interventions appear to be cost-effective relative to usual care, but this is subject to considerable uncertainty. Future work recommendations: Several interventions appear to be cost-effective relative to usual care, but this is subject to considerable uncertainty. Future research conducting RCTs to establish which interventions are most clinically effective and cost-effective should be considered. Study registration: This study is registered as PROSPERO CRD42012003273. Funding: The National Institute for Health Research Health Technology Assessment programme.

Background: Despite many years of research, there is no certainty regarding the cause of stuttering. Although numerous interventions have been developed, a broad-based systematic review across all forms of intervention for adults and children was needed including views and perceptions of people who stutter. Objective: The aims of the study were to report the clinical effectiveness of interventions for people who stutter (or clutter), to examine evidence regarding the views of people who stutter and the views of professionals regarding interventions. Data sources: A systematic review of quantitative and qualitative literature was carried out between August 2013 and April 2014. The following electronic databases were searched: (1) MEDLINE, (2) EMBASE, (3) The Cochrane Library (including The Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, Health Technology Assessment Database and NHS Economic Evaluations Database), (4) PsycINFO, (5) Science Citation Index, (6) Social Science Citation Index, (7) Cumulative Index to Nursing and Allied Health Literature, (8) ASSIA, (9) Linguistics and Language Behavior Abstracts, (10) Sociological Abstracts and (11) the EPPI Centre. Reference lists of included papers and other reviews were screened and also key journals in the subject area were hand-searched. Review methods: The searches aimed to identify (1) evidence of clinical effectiveness in populations of pre-school children, school-aged children, adolescents and adults, and (2) data relating to perceptions of barriers and facilitators to intervention clinical effectiveness among staff and people who stutter. A metasynthesis of the two linked elements via development of a conceptual model was also carried out to provide further interpretation of the review findings. Results: A systematic search of the literature identified a large number of potentially relevant studies. Of these, 111 studies examining the clinical effectiveness of interventions, 25 qualitative papers and one mixed-methods paper met the criteria for inclusion in this review. Review of the effectiveness literature indicated evidence of positive outcomes across all types of interventions. Virtually all evidence we identified reported at least some positive effect for some participants. However, there was evidence of considerable individual variation in outcome for study participants. The qualitative literature highlighted the need for programmes to be tailored to individual need with variation at the levels of the intervention, the individual and interpersonal/social elements. Metasynthesis of the data highlighted the complexity of elements that need to be considered in evaluation of long-term impacts following stuttering interventions. Limitations: Around two-thirds of the studies were considered to be at higher risk of bias. The heterogeneous nature and variability in outcomes meant that we were unable to complete a meta-analysis. Conclusions: Although much of the evidence we identified was from studies at risk of bias, it is suggested that most available interventions for stuttering may be of benefit to at least some people who stutter. There is a requirement for greater clarity regarding what the core outcomes following stuttering intervention should be and also enhanced understanding of the process whereby interventions effect change. Further analysis of those for whom interventions have not produced a significant benefit may provide additional insights into the complex intervention–outcomes pathway. Study registration: This study is registered as PROSPERO CRD42013004861. Funding: The National Institute for Health Research Health Technology Assessment programme.

Background: Group clinics are a form of delivering specialist-led care in groups rather than in individual consultations. Objective: To examine the evidence for the use of group clinics for patients with chronic health conditions. Design: A systematic review of evidence from randomised controlled trials (RCTs) supplemented by qualitative studies, cost studies and UK initiatives. Data sources: We searched MEDLINE, EMBASE, The Cochrane Library, Web of Science and Cumulative Index to Nursing and Allied Health Literature from 1999 to 2014. Systematic reviews and RCTs were eligible for inclusion. Additional searches were performed to identify qualitative studies, studies reporting costs and evidence specific to UK settings. Review methods: Data were extracted for all included systematic reviews, RCTs and qualitative studies using a standardised form. Quality assessment was performed for systematic reviews, RCTs and qualitative studies. UK studies were included regardless of the quality or level of reporting. Tabulation of the extracted data informed a narrative synthesis. We did not attempt to synthesise quantitative data through formal meta-analysis. However, given the predominance of studies of group clinics for diabetes, using common biomedical outcomes, this subset was subject to quantitative analysis. Results: Thirteen systematic reviews and 22 RCT studies met the inclusion criteria. These were supplemented by 12 qualitative papers (10 studies), four surveys and eight papers examining costs. Thirteen papers reported on 12 UK initiatives. With 82 papers covering 69 different studies, this constituted the most comprehensive coverage of the evidence base to date. Disease-specific outcomes – the large majority of RCTs examined group clinic approaches to diabetes. Other conditions included hypertension/heart failure and neuromuscular conditions. The most commonly measured outcomes for diabetes were glycated haemoglobin A1c (HbA1c), blood pressure and cholesterol. Group clinic approaches improved HbA1c and improved systolic blood pressure but did not improve low-density lipoprotein cholesterol. A significant effect was found for disease-specific quality of life in a few studies. No other outcome measure showed a consistent effect in favour of group clinics. Recent RCTs largely confirm previous findings. Health services outcomes – the evidence on costs and feasibility was equivocal. No rigorous evaluation of group clinics has been conducted in a UK setting. A good-quality qualitative study from the UK highlighted factors such as the physical space and a flexible appointment system as being important to patients. The views and attitudes of those who dislike group clinic provision are poorly represented. Little attention has been directed at the needs of people from ethnic minorities. The review team identified significant weaknesses in the included research. Potential selection bias limits the generalisability of the results. Many patients who could potentially be included do not consent to the group approach. Attendance is often interpreted liberally. Limitations: This telescoped review, conducted within half the time period of a conventional systematic review, sought breadth in covering feasibility, appropriateness and meaningfulness in addition to effectiveness and cost-effectiveness and utilised several rapid-review methods. It focused on the contribution of recently published evidence from RCTs to the existing evidence base. It did not reanalyse trials covered in previous reviews. Following rapid review methods, we did not perform independent double data extraction and quality assessment. Conclusions: Although there is consistent and promising evidence for an effect of group clinics for some biomedical measures, this effect does not extend across all outcomes. Much of the evidence was derived from the USA. It is important to engage with UK stakeholders to identify NHS considerations relating to the implementation of group clinic approaches. Future work: The review team identified three research priorities: (1) more UK-centred evaluations using rigorous research designs and economic models with robust components; (2) clearer delineation of individual components within different models of group clinic delivery; and (3) clarification of the circumstances under which group clinics present an appropriate alternative to an individual consultation. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

Background: In 2013 NHS England set out its strategy for the development of an emergency and urgent care system that is more responsive to patients’ needs, improves outcomes and delivers clinically excellent and safe care. Knowledge about the current evidence base on models for provision of safe and effective urgent care, and the gaps in evidence that need to be addressed, can support this process. Objective: The purpose of the evidence synthesis is to assess the nature and quality of the existing evidence base on delivery of emergency and urgent care services and identify gaps that require further primary research or evidence synthesis. Data sources: MEDLINE, EMBASE, The Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the Web of Science. Methods: We have conducted a rapid, framework-based, evidence synthesis approach. Five separate reviews linked to themes in the NHS England review were conducted. One general and five theme-specific database searches were conducted for the years 1995–2014. Relevant systematic reviews and additional primary research papers were included and narrative assessment of evidence quality was conducted for each review. Results: The review was completed in 6 months. In total, 45 systematic reviews and 102 primary research studies have been included across all five reviews. The key findings for each review are as follows: (1) demand – there is little empirical evidence to explain increases in demand for urgent care; (2) telephone triage – overall, these services provide appropriate and safe decision-making with high patient satisfaction, but the required clinical skill mix and effectiveness in a system is unclear; (3) extended paramedic roles have been implemented in various health settings and appear to be successful at reducing the number of transports to hospital, making safe decisions about the need for transport and delivering acceptable, cost-effective care out of hospital; (4) emergency department (ED) – the evidence on co-location of general practitioner services with EDs indicates that there is potential to improve care. The attempt to summarise the evidence about wider ED operations proved to be too complex and further focused reviews are needed; and (5) there is no empirical evidence to support the design and development of urgent care networks. Limitations: Although there is a large body of evidence on relevant interventions, much of it is weak, with only very small numbers of randomised controlled trials identified. Evidence is dominated by single-site studies, many of which were uncontrolled. Conclusions: The evidence gaps of most relevance to the delivery of services are (1) a requirement for more detailed understanding and mapping of the characteristics of demand to inform service planning; (2) assessment of the current state of urgent care network development and evaluation of the effectiveness of different models; and (3) expanding the current evidence base on existing interventions that are viewed as central to delivery of the NHS England plan by assessing the implications of increasing interventions at scale and measuring costs and system impact. It would be prudent to develop a national picture of existing pilot projects or interventions in development to support decisions about research commissioning. Funding: The National Institute for Health Research Health Services and Delivery Research Programme.

Background: Non-invasive ventilation (NIV), in the form of continuous positive airway pressure (CPAP) or bilevel inspiratory positive airway pressure (BiPAP), is used in hospital to treat patients with acute respiratory failure. Pre-hospital NIV may be more effective than in-hospital NIV but requires additional ambulance service resources. Objectives: We aimed to determine the clinical effectiveness and cost-effectiveness of pre-hospital NIV compared with usual care for adults presenting to the emergency services with acute respiratory failure and to identify priorities for future research. Data sources: Fourteen electronic databases and research registers (including MEDLINE In-Process & Other Non-Indexed Citations, MEDLINE, EMBASE, and Cumulative Index to Nursing and Allied Health Literature) were searched from inception to August 2013, supplemented by hand-searching reference lists and contacting experts in the field. Review methods: We included all randomised or quasi-randomised controlled trials of pre-hospital NIV in patients with acute respiratory failure. Methodological quality was assessed according to established criteria. An aggregate data network meta-analysis (NMA) of mortality and intubation was used to jointly estimate intervention effects relative to usual care. A NMA, using individual patient-level data (IPD) and aggregate data where IPD were not available, was carried out to assess whether or not covariates were treatment effect modifiers. A de novo economic model was developed to explore the costs and health outcomes when pre-hospital NIV (specifically CPAP provided by paramedics) and standard care (in-hospital NIV) were applied to a hypothetical cohort of patients with acute respiratory failure. Results: The literature searches identified 2284 citations. Of the 10 studies that met the inclusion criteria, eight were randomised controlled trials and two were quasi-randomised trials (six CPAP; four BiPAP; sample sizes 23–207 participants). IPD were available from seven trials (650 patients). The aggregate data NMA suggested that CPAP was the most effective treatment in terms of mortality (probability = 0.989) and intubation rate (probability = 0.639), and reduced both mortality [odds ratio (OR) 0.41, 95% credible interval (CrI) 0.20 to 0.77] and intubation rate (OR 0.32, 95% CrI 0.17 to 0.62) compared with standard care. The effect of BiPAP on mortality (OR 1.94, 95% CrI 0.65 to 6.14) and intubation rate (OR 0.40, 95% CrI 0.14 to 1.16) compared with standard care was uncertain. The combined IPD and aggregate data NMA suggested that sex was a statistically significant treatment effect modifier for mortality. The economic analysis showed that pre-hospital CPAP was more effective and more expensive than standard care, with an incremental cost-effectiveness ratio of £20,514 per quality-adjusted life-year (QALY) and a 49.5% probability of being cost-effective at the £20,000-per-QALY threshold. Variation in the incidence of eligible patients had a marked impact on cost-effectiveness and the expected value of sample information for a future randomised trial. Limitations: The meta-analysis lacked power to detect potentially important differences in outcome (particularly for BiPAP), the intervention was not always compared with the best alternative care (in-hospital NIV) in the primary studies and findings may not be generalisable. Conclusions: Pre-hospital CPAP can reduce mortality and intubation rates, but cost-effectiveness is uncertain and the value of further randomised evaluation depends on the incidence of suitable patients. A feasibility study is required to determine if a large pragmatic trial of clinical effectiveness and cost-effectiveness is appropriate. Study registration: The study is registered as PROSPERO CRD42012002933. Funding: The National Institute for Health Research Health Technology Assessment programme.

Background: Premature ejaculation (PE) is commonly defined as ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the person wishes it. PE can be either lifelong and present since first sexual experiences (primary), or acquired (secondary), beginning later (Godpodinoff ML. Premature ejaculation: clinical subgroups and etiology. J Sex Marital Ther 1989;15:130–4). Treatments include behavioural and pharmacological interventions. Objective: To systematically review evidence for clinical effectiveness of behavioural, topical and systemic treatments for PE. Data sources: The following databases were searched from inception to 6 August 2013 for published and unpublished research evidence: MEDLINE; EMBASE; Cumulative Index to Nursing and Allied Health Literature; The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects and the Health Technology Assessment database; ISI Web of Science, including Science Citation Index, and the Conference Proceedings Citation Index-Science. The US Food and Drug Administration website and the European Medicines Agency (EMA) website were also searched. Methods: Randomised controlled trials (RCTs) in adult men with PE were eligible (or non-RCTs in the absence of RCTs). RCT data were extrapolated from review articles when available. The primary outcome was intravaginal ejaculatory latency time (IELT). Data were meta-analysed when possible. Other outcomes included sexual satisfaction, control over ejaculation, relationship satisfaction, self-esteem, quality of life, treatment acceptability and adverse events (AEs). Results: A total of 103 studies (102 RCTs, 65 from reviews) were included. RCTs were available for all interventions except yoga. The following interventions demonstrated significant improvements (p

Background: Tobacco smoking is one of the leading causes of deaths worldwide. Nearly one-fifth of adults in the UK regularly smoke cigarettes. The ill-health associated with smoking costs the NHS over £3B every year. A number of pharmacological interventions are available that can help people to quit smoking. These include nicotinic receptor partial agonists such as varenicline or cytisine. Varenicline is a synthetic product licensed for use in the UK, while cytisine is derived naturally from the seeds of the plant Cytisus laborinum L. (golden rain acacia). Objectives: To review the evidence on the clinical effectiveness and safety of cytisine from smoking cessation compared with varenicline; to develop an economic model to estimate the cost-effectiveness of cytisine and varenicline; and to provide recommendations based on value of information analyses as to whether or not a head-to-head trial of cytisine and varenicline would represent effective use of resources. Data sources: Efficacy and adverse events data were sourced from a recent Cochrane review. These data were supplemented with an updated search of twelve electronic databases, including MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature and The Cochrane Library, for the period from December 2011 to January 2013. The review included randomised controlled trials (RCTs) of adult smokers attempting to quit using varenicline or cytisine. Further interventions were considered (placebo, nicotine replacement therapy, bupropion) to allow an indirect comparison between varenicline and cytisine. The primary outcome was abstinence at a minimum of 6 months’ follow-up. Secondary outcomes were common adverse events such as abnormal dreams, headache, nausea, insomnia and serious adverse events. Review methods: A systematic review and network meta-analysis of the clinical evidence was undertaken. A random-effects model was used to allow for heterogeneity between studies. The economic model structure was based on a published model. Probabilistic sensitivity analyses were undertaken to estimate the treatment expected to be most cost-effective given current information. Formal expected value of perfect information, perfect partial information and of sample information were performed. Results: Twenty-three (RCTs) were included in the systematic review, comprising a total of 10,610 participants. Twenty-one trials of varenicline of differing dosing schedules and two trials of cytisine at standard dose met the inclusion criteria. No head-to-head trials comparing varenicline with cytisine were identified. The methodological quality of the studies was judged to be moderate to good. Cytisine was more efficacious than placebo [hazard ratio (HR) 4.27, 95% credible interval (CrI) 2.05 to 10.05], as was standard-dose varenicline (HR 2.58, 95% Crl 2.16 to 3.15). Standard-dose varenicline treatment was associated with significantly higher rates of headache, insomnia and nausea than placebo; there was no significant difference in the rates of abnormal dreams. There were no significant differences in the rates of headache or nausea between cytisine and placebo; data were identified for neither abnormal dreams nor insomnia. Using expected values, cytisine is anticipated to dominate varenicline, in that it produces more quality-adjusted life-years at a lower associated cost. This occurred in approximately 90% of the scenarios performed. However, owing to the large number of people who wish to quit smoking (estimated to be 3 million over a 10-year period), the implications of making an incorrect decision is large. The expected value of sample information indicated that conducting a head-to-head trial of cytisine and varenicline was worthwhile, and that 1000 smokers per arm was an appropriate number to recruit. Conclusions: On the basis of the evidence included in this review, varenicline and cytisine are both effective interventions to aid smoking cessation when compared with placebo. Cytisine is estimated to be both more clinically effective and cost-effective than varenicline. However, there is uncertainty in the decision, and a head-to-head trial of cytisine and varenicline would appear to be an effective use of resources. Study registration: The study was registered as PROSPERO CRD42012003455. Funding details: The National Institute for Health Research Health Technology Assessment programme.