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Abstract Background People with motor neuron disease (pwMND) are routinely offered gastrostomy feeding tube placement and (non‐invasive and invasive) ventilation to manage the functional decline associated with the disease. This study aimed to synthesise the findings from the qualitative literature to understand how individual, clinical team and organisational factors influence pwMND decisions about these interventions. Methods The study design was guided by the enhancing transparency in reporting the synthesis of qualitative research (ENTREC) statement. The search of five bibliography databases and an extensive supplementary search strategy identified 27 papers that included qualitative accounts of pwMND, caregivers and healthcare professionals' (HCPs) experiences of making decisions about gastrostomy and ventilation. The findings from each study were included in a thematic synthesis. Findings Making decisions about interventions is an emotional rather than simply a functional issue for pwMND. The interventions can signal an end to normality, and increasing dependence, where pwMND consider the balance between quality of life and extending survival. Interactions with multiple HCPs and caregivers can influence the process of decision‐making and the decisions made. These interactions contribute to the autonomy pwMND are able to exert during decision‐making. HCPs can both promote and threaten pwMND perceived agency over decisions through how they approach discussions about these interventions. Though there is uncertainty over the timing of interventions, pwMND who agree to interventions report reaching a tipping point where they accept the need for change. Conclusion Discussion of gastrostomy and ventilation options generate an emotional response in pwMND. Decisions are the consequence of interactions with multiple external agents, including HCPs treading a complex ethical path when trying to improve health outcomes while respecting pwMND right to autonomy. Future decision support interventions that address the emotional response and seek to support autonomy have the potential to enable pwMND to make informed and timely decisions about gastrostomy placement and ventilation. Patient or Public Contribution The lead author collaborated with several patient and participant involvement (PPI) groups with regards to the conceptualisation and design of this project. Decisions that have been influenced by discussions with multiple PPI panels include widening the scope of decisions about ventilation in addition to gastrostomy placement and the perceptions of all stakeholders involved (i.e., pwMND, caregivers and HCPs).

Introduction One-fifth of children start school already overweight or living with obesity, with rates disproportionately impacting those living in the most deprived areas. Social, environmental and biological factors contribute to excess weight gain and programmes delivered in early years settings aim to support families to navigate these in order to prevent obesity. One of these programmes (Health, Exercise and Nutrition for the Really Young, HENRY) has been delivered in UK community venues (hereon named ‘centres’) in high deprivation areas since 2008 and aims to help families to provide a healthy start for their preschool children. We aim to establish the effectiveness and cost-effectiveness of HENRY, including its potential role from a wider systems perspective.Methods and analysis This is a multicentre, open-labelled, two-group, prospective, cluster randomised controlled trial, with cost-effectiveness analysis, systems-based process evaluation and internal pilot. Primary analysis will compare body mass index (BMI) z-score at 12 months in children (n=984) whose parents have attended HENRY to those who have not attended. Secondary outcomes include parent and staff BMI and waist circumference, parenting efficacy, feeding, eating habits, quality of life, resource use and medium term (3 years) BMI z-scores (child and siblings). 82 centres in ~14 local authority areas will be randomised (1:1) to receive HENRY or continue with standard practice. Intention-to-treat analysis will compare outcomes using mixed effects linear regression. Economic evaluation will estimate a within-trial calculation of cost-per unit change in BMI z-score and longer-term trajectories to determine lifelong cost savings (long-term outcomes). A systems process evaluation will explore whether (and how) implementation of HENRY impacts (and is impacted by) the early years obesity system. An established parent advisory group will support delivery and dissemination.Ethics and dissemination Ethical approval has been granted by the University of York, Health Sciences’ Research Governance Committee (HSRGC/2022/537/E). Dissemination includes policy reports, community resources, social media and academic outputs.Trial registration number ISRCTN16529380.

Introduction Ovarian hyperstimulation syndrome (OHSS) is the most significant short-term complication of pharmacological ovarian stimulation. Symptoms range from mild abdominal discomfort to rare complications such as renal failure, thromboembolism and respiratory distress syndrome.Currently, clinical practice typically involves monitoring the patient until the condition becomes severe, at which point they are admitted to hospital, where drainage of ascitic fluid (paracentesis) may take place. Preliminary studies have indicated that earlier outpatient paracentesis may reduce the progression of OHSS and prevent hospitalisation in women.Methods and analysis This UK, multicentre, pragmatic, two-arm, parallel-group, adaptive (group sequential with one interim analysis), open-label, superiority, confirmatory, group sequential, individually randomised controlled trial, with internal pilot will assess the clinical and cost-effectiveness and safety of outpatient paracentesis versus conservative management (usual care) for moderate or severe OHSS. 224 women from 20 National Health Service and private fertility units will be randomised (1:1) and followed up for up to 13.5 months. The primary outcome is the rate of OHSS related hospital admission of at least 24 hours within 28 days postrandomisation. The primary analysis will be an intention to treat with difference in hospitalisation rates as measure of treatment effect. Secondary outcomes include time to resolution of symptoms, patient satisfaction, adverse events and cost-effectiveness. A qualitative substudy will facilitate the feasibility of recruitment. Participant recruitment commenced in June 2022.Ethics and dissemination London—Southeast Research Ethics Committee approved the protocol (reference: 22/LO/0015). Findings will be submitted to peer-reviewed journals and abstracts to relevant national and international conferences, as well as being disseminated to trial participants and patient groups.Trial registration number ISRCTN71978064.

Abstract Background Third sector organisations such as charities and community groups are using Patient Reported Outcome Measures (PROMs) at an aggregated service level to demonstrate their impact to commissioners to generate or retain funding. Despite this motivation, organisations can struggle with implementing PROMs. Previous studies have identified facilitators including organisations using an appropriate measure, co-producing the PROMs process with staff, and investing resources to support the use of measures. However, to date no studies have applied this learning to third sector organisations to evaluate whether taking an evidence-informed implementation approach improves the use of PROMs. Methods A Community-Based Participatory Research approach was used which involved university-based researchers supporting two third sector organisations to implement PROMs. The researchers provided evidence-informed advice and training. The organisations were responsible for implementing PROMs. The researchers evaluated implementation through a mixed methods approach including five key informant interviews, four evaluation groups and analysis of collected PROMs data (n = 313). Results Both third sector organisations faced considerable constraints in incorporating known facilitators and addressing barriers. The organisations involved staff in choosing an acceptable measure. However, competing priorities including external pressures to use specific PROMs, busy workloads and staff opinions created challenges to using measures. Investment of time and energy into developing an outcomes-based organisational culture was key to enable the prioritisation of PROMs. For example, discussing PROMs in supervision so that they were viewed as part of people’s job roles. Organisations found that implementation took several years and was disrupted by other pressures. Conclusions Whilst organisations were motivated to implement PROMs to obtain or retain funding, they faced considerable practical and ideological challenges. Consequently, some stakeholders felt that alternative methods to measuring impact could potentially be more feasible than PROMs.

Abstract Background Knowledge mobilisation is a term used in healthcare research to describe the process of generating, sharing and using evidence. ‘Co’approaches, such as co-production, co-design and co-creation, have been proposed as a way of overcoming the knowledge to practice gap. There is a need to understand why researchers choose to adopt these approaches, how they achieve knowledge mobilisation in the management of health conditions, and the extent to which knowledge mobilisation is accomplished. Methods Studies that explicitly used the terms co-production, co-design or co-creation to mobilise knowledge in the management of health conditions were included. Web of Science, EMBASE via OvidSP, MEDLINE via OvidSP and CINHAL via EBSCO databases were searched up to April 2021. Quality assessment was carried out using the Joanna Briggs Institute qualitative quality assessment checklist. Pluye and Hong’s seven steps for mixed studies reviews were followed. Data were synthesised using thematic synthesis. Results Twenty four international studies were included. These were qualitative studies, case studies and study protocols. Key aspects of ‘co’approaches were bringing people together as active and equal partners, valuing all types of knowledge, using creative approaches to understand and solve problems, and using iterative prototyping techniques. Authors articulated mechanisms of action that included developing a shared understanding, identifying and meeting needs, giving everyone a voice and sense of ownership, and creating trust and confidence. They believed these mechanisms could produce interventions that were relevant and acceptable to stakeholders, more useable and more likely to be implemented in healthcare. Varied activities were used to promote these mechanisms such as interviews and creative workshops. There appeared to be a lack of robust evaluation of the interventions produced so little evidence in this review that ‘co’approaches improved the management of health conditions. Conclusion Those using ‘co’approaches believed that they could achieve knowledge mobilisation through a number of mechanisms, but there was no evidence that these led to improved health. The framework of key aspects and mechanisms of ‘co’approaches developed here may help researchers to meet the principles of these approaches. There is a need for robust evaluation to identify whether ‘co’approaches produce improved health outcomes. Trial Registration PROSPERO CRD42020187463 .

Abstract Background Many clinical trial procedures were often undertaken in-person prior to the COVID-19 pandemic, which has resulted in adaptations to these procedures to enable trials to continue. The aim of this study was to understand whether the adaptations made to clinical trials by UK Clinical Trials Units (CTUs) during the pandemic have the potential to improve the efficiency of trials post-pandemic. Methods This was a mixed methods study, initially involving an online survey administered to all registered UK CTUs to identify studies that had made adaptations due to the pandemic. Representatives from selected studies were qualitatively interviewed to explore the adaptations made and their potential to improve the efficiency of future trials. A literature review was undertaken to locate published evidence concerning the investigated adaptations. The findings from the interviews were reviewed by a group of CTU and patient representatives within a workshop, where discussions focused on the potential of the adaptations to improve the efficiency of future trials. Results Forty studies were identified by the survey. Fourteen studies were selected and fifteen CTU staff were interviewed about the adaptations. The workshop included 15 CTU and 3 patient representatives. Adaptations were not seen as leading to direct efficiency savings for CTUs. However, three adaptations may have the potential to directly improve efficiencies for trial sites and participants beyond the pandemic: a split remote-first eligibility assessment, recruitment outside the NHS via a charity, and remote consent. There was a lack of published evidence to support the former two adaptations, however, remote consent is widely supported in the literature. Other identified adaptations may benefit by improving flexibility for the participant. Barriers to using these adaptations include the impact on scientific validity, limitations in the role of the CTU, and participant’s access to technology. Conclusions Three adaptations (a split remote-first eligibility assessment, recruitment outside the NHS via a charity, and remote consent) have the potential to improve clinical trials but only one (remote consent) is supported by evidence. These adaptations could be tested in future co-ordinated ‘studies within a trial’ (SWAT).

Background: Health literacy is the ability to find information, understand information, know how to act on information and know which services to use. Having higher levels of health literacy may help patients to look after minor problems themselves (self-care). It may also help to reduce patients’ perceived need for contacting health services for minor health problems, to reduce the perceived urgency of problems or to improve patients’ ability to identify and choose from the range of available services. Interventions to improve health literacy for minor health problems have been evaluated, but their effectiveness at reducing use of primary care and emergency services has not been synthesised. Objectives: The key objectives were as follows: (1) to construct a typology of interventions that aim to reduce primary or emergency care use, (2) to synthesise evidence of the effectiveness of different types of health literacy interventions and (3) to consider how stakeholders in the UK could operationalise the evidence. Interventions: The interventions being reviewed were initiatives that help members of the population to self-care or make decisions about whether or not and where to seek health care for minor health problems. Design: This study was a systematic review with stakeholder involvement. Data sources and review methods: A meeting was held with 14 stakeholders (including patients, carers and the public) to guide the systematic review. This was followed by a multicomponent review of quantitative and qualitative research. Database literature searches were undertaken in Ovid MEDLINE, The Cochrane Library (via Wiley Interscience), EMBASE (via OVID), the Cumulative Index to Nursing and Allied Health Literature (via EBSCO), PsycINFO (via OVID), Web of Science and Sociological Abstracts. The search was limited to English-language publications from 1990–2020. To assess study quality, the Cochrane Risk of Bias tool was used for randomised controlled trials and the Newcastle–Ottawa Scale was used for non-randomised studies. A narrative synthesis was undertaken. The review was followed by a meeting with 16 stakeholders to interpret the results. Results: A total of 67 articles (64 studies) were included: 37 from the USA, 16 from the UK, 12 from the rest of Europe and two from the rest of the world. There were seven intervention types: navigation tools directing people to the range of services available (n = 7); written education about managing minor health problems in booklet or website format (n = 17); person-delivered education (n = 5); written education with person-delivered education (n = 17); multicomponent of written education, person-delivered education and mass media campaign (n = 5); self-triage (n = 9); and other (n = 7). Our team assessed the readability and user-friendliness of interventions, and found that these varied widely. When assessed, most studies measuring satisfaction with the intervention, enablement and perceived changes to behaviour showed positive results. Of 30 articles reporting impact on emergency department attendances, 19 (63%) showed a reduction, and 16/27 (59%) articles measuring impact on general practice consultations showed a reduction. Variation in the evidence base was not explained by any research, context or intervention characteristics. Only eight articles measured safety: these identified no problems. Limitations: There was inconsistency in how the outcomes were measured, so a meta-analysis was not possible. Conclusions: Health literacy interventions have potential to affect emergency and primary care use, but the evidence base is inconsistent. Future research: It is important to continue to evaluate these types of initiatives. Study registration: This study is registered as PROSPERO CRD42020214206. 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. 38. See the NIHR Journals Library website for further project information.

Abstract Background Studies have identified young adults as more likely to use emergency departments for ‘clinically unnecessary’ problems, with limited similar evidence for emergency ambulance use. Media portrayals depict young adults as motivated by ‘convenience’, but little research has explored the reasons for their help‐seeking behaviour. Methods Qualitative interviews with 16 young adults (18‐30) considered by clinicians to have made unnecessary use of emergency ambulance, emergency department or an urgent GP appointment. Data analysis was informed by interpretive phenomenological analysis. Findings A number of interrelated factors contributed to participants’ decisions. They were anxious about the seriousness of their symptoms, sometimes exacerbated by reduced coping capacity due to poor mental health or life stresses. They looked to others to facilitate their decision making, who sometimes encouraged urgent contact. They wanted to avoid impact on existing day‐to‐day commitments including work or study. They had strong views about different health services, sometimes based on frustration with lack of resolution of on‐going health problems. Convenience was not identified as a significant factor, although some actions could be interpreted in this light if the context was not considered. Conclusions Young adults make ‘clinically unnecessary’ use of urgent and emergency care for more than convenience. Their decisions need to be understood in relation to the complexity of their experience, including lack of confidence in making health‐related decisions, lowered coping capacity and concern to maintain normal daily life.

Abstract Background A person’s health literacy determines whether they are able to make appropriate health decisions and are able to follow treatment instructions. This is important because low health literacy is associated with mortality and extra costs to the healthcare system. Our aim was to describe the health literacy levels of British adults using a nationally representative population survey, and show how health literacy levels vary by population characteristics. Methods A population based cross-sectional survey including questions from two domains from the Health Literacy Questionnaire™: 1) Understanding health information well enough to know what to do, and 2) Ability to actively engage with health care providers. Both domains are made up of 5 Likert style questions with 5 levels ranging from ‘cannot do or always difficult’ (1) to ‘always easy’ (5). The survey was conducted by NatCen in Britain (2018) as part of the annual British Social Attitudes survey. We used weighted descriptive analyses and regression to explore the relationship between population characteristics and health literacy. Weighted analyses were used to ensure the sample was representative of the British population. Results A total of 2309 responded to the questionnaire. The mean score for ‘understanding information’ was 3.98 (95% CI: 3.94, 4.02) and for ‘ability to engage’ was 3.83 (95% CI: 3.80, 3.87), where 5 is the highest score. 19.4% had some level of difficulty reading and understanding written health information, and 23.2% discussing health concerns with health care providers. The adjusted logistic regression for ‘understanding information’ showed that those with lower health literacy were more likely to be in the most socially deprived quintile (OR 2.500 95% CI: 1.180, 5.296), have a limiting health condition or disability (OR 4.326 95% CI: 2.494, 7.704), and have no educational qualifications (OR 7.588 95% CI: 3.305, 17.422). This was similar for the ‘ability to engage’ domain. Conclusions This study described the distribution of health literacy levels for the British population in 2018. Interventions to improve health literacy will best be targeted at those with lower levels of education, those living in the most deprived areas, and those with a limiting health condition or disability.

Abstract Background Demand is labelled ‘clinically unnecessary’ when patients do not need the levels of clinical care or urgency provided by the service they contact. Objective To identify programme theories which seek to explain why patients make use of emergency and urgent care that is subsequently judged as clinically unnecessary. Design Realist review. Methods Papers from four recent systematic reviews of demand for emergency and urgent care, and an updated search to January 2017. Programme theories developed using Context‐Mechanism‐Outcome chains identified from 32 qualitative studies and tested by exploring their relationship with existing health behaviour theories and 29 quantitative studies. Results Six mechanisms, based on ten interrelated programme theories, explained why patients made clinically unnecessary use of emergency and urgent care: (a) need for risk minimization, for example heightened anxiety due to previous experiences of traumatic events; (b) need for speed, for example caused by need to function normally to attend to responsibilities; (c) need for low treatment‐seeking burden, caused by inability to cope due to complex or stressful lives; (d) compliance, because family or health services had advised such action; (e) consumer satisfaction, because emergency departments were perceived to offer the desired tests and expertise when contrasted with primary care; and (f) frustration, where patients had attempted and failed to obtain a general practitioner appointment in the desired timeframe. Multiple mechanisms could operate for an individual. Conclusions Rather than only focusing on individuals' behaviour, interventions could include changes to health service configuration and accessibility, and societal changes to increase coping ability.

Background: People with cystic fibrosis frequently have low levels of adherence to inhaled medications. Objectives: The objectives were to develop and evaluate an intervention for adults with cystic fibrosis to improve adherence to their inhaled medication. Design: We used agile software methods to develop an online platform. We used mixed methods to develop a behaviour change intervention for delivery by an interventionist. These were integrated to become the CFHealthHub intervention. We undertook a feasibility study consisting of a pilot randomised controlled trial and process evaluation in two cystic fibrosis centres. We evaluated the intervention using an open-label, parallel-group randomised controlled trial with usual care as the control. Participants were randomised in a 1 : 1 ratio to intervention or usual care. Usual care consisted of clinic visits every 3 months. We undertook a process evaluation alongside the randomised controlled trial, including a fidelity study, a qualitative interview study and a mediation analysis. We undertook a health economic analysis using both a within-trial and model-based analysis. Setting: The randomised controlled trial took place in 19 UK cystic fibrosis centres. Participants: Participants were people aged ≥ 16 years with cystic fibrosis, on the cystic fibrosis registry, not post lung transplant or on the active transplant list, who were able to consent and not using dry-powder inhalers. Intervention: People with cystic fibrosis used a nebuliser with electronic monitoring capabilities. This transferred data automatically to a digital platform. People with cystic fibrosis and clinicians could monitor adherence using these data, including through a mobile application (app). CFHealthHub displayed graphs of adherence data as well as educational and problem-solving information. A trained interventionist helped people with cystic fibrosis to address their adherence. Main outcome measures: Randomised controlled trial – adjusted incidence rate ratio of pulmonary exacerbations meeting the modified Fuchs criteria over a 12-month follow-up period (primary outcome); change in percentage adherence; and per cent predicted forced expiratory volume in 1 second (key secondary outcomes). Process evaluation – percentage fidelity to intervention delivery, and participant and interventionist perceptions of the intervention. Economic modelling – incremental cost per quality-adjusted life-year gained. Results: Randomised controlled trial – 608 participants were randomised to the intervention (n = 305) or usual care (n = 303). To our knowledge, this was the largest randomised controlled trial in cystic fibrosis undertaken in the UK. The adjusted rate of exacerbations per year (primary outcome) was 1.63 in the intervention and 1.77 in the usual-care arm (incidence rate ratio 0.96, 95% confidence interval 0.83 to 1.12; p = 0.638) after adjustment for covariates. The adjusted difference in mean weekly normative adherence was 9.5% (95% confidence interval 8.6% to 10.4%) across 1 year, favouring the intervention. Adjusted mean difference in forced expiratory volume in 1 second (per cent) predicted at 12 months was 1.4% (95% confidence interval –0.2% to 3.0%). No adverse events were related to the intervention. Process evaluation – fidelity of intervention delivery was high, the intervention was acceptable to people with cystic fibrosis, participants engaged with the intervention [287/305 (94%) attended the first intervention visit], expected mechanisms of action were identified and contextual factors varied between randomised controlled trial sites. Qualitative interviews with 22 people with cystic fibrosis and 26 interventionists identified that people with cystic fibrosis welcomed the objective adherence data as proof of actions to self and others, and valued the relationship that they built with the interventionists. Economic modelling – the within-trial analysis suggests that the intervention generated 0.01 additional quality-adjusted life-years at an additional cost of £865.91 per patient, leading to an incremental cost-effectiveness ratio of £71,136 per quality-adjusted life-year gained. This should be interpreted with caution owing to the short time horizon. The health economic model suggests that the intervention is expected to generate 0.17 additional quality-adjusted life-years and cost savings of £1790 over a lifetime (70-year) horizon; hence, the intervention is expected to dominate usual care. Assuming a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained, the probability that the intervention generates more net benefit than usual care is 0.89. The model results are dependent on assumptions regarding the duration over which costs and effects of the intervention apply, the impact of the intervention on forced expiratory volume in 1 second (per cent) predicted and the relationship between increased adherence and drug-prescribing levels. Limitations: Number of exacerbations is a sensitive and valid measure of clinical change used in many trials. However, data collection of this outcome in this context was challenging and could have been subject to bias. It was not possible to measure baseline adherence accurately. It was not possible to quantify the impact of the intervention on the number of packs of medicines prescribed. Conclusions: We developed a feasible and acceptable intervention that was delivered to fidelity in the randomised controlled trial. We observed no statistically significant difference in the primary outcome of exacerbation rates over 12 months. We observed an increase in normative adherence levels in a disease where adherence levels are low. The magnitude of the increase in adherence may not have been large enough to affect exacerbations. Future work: Given the non-significant difference in the primary outcome, further research is required to explore why an increase in objective normative adherence did not reduce exacerbations and to develop interventions that reduce exacerbations. Trial registration: Work package 3.1: Current Controlled Trials ISRCTN13076797. Work packages 3.2 and 3.3: Current Controlled Trials ISRCTN55504164. Funding: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 11. See the NIHR Journals Library website for further project information.

Abstract Background Researchers publish the processes they use to develop interventions to improve health. Reflecting on this endeavour may help future developers to improve their practice. Methods Our aim was to collate, describe, and analyse the actions developers take when developing complex interventions to improve health. We carried out a systematic mapping review of empirical research studies that report the development of complex interventions to improve health. A search was undertaken of five databases over 2015–2016 using the term ‘intervention dev*’. Eighty-seven journal articles reporting the process of intervention development were identified. A purposive subset of 30 articles, using a range of published approaches to developing interventions, was selected for in-depth analysis using principles of realist synthesis to identify the actions of intervention development and rationales underpinning those actions. Results The 87 articles were from the USA (39/87), the UK (32/87), continental Europe (6/87), and the rest of the world (10/87). These mainly took a pragmatic self-selected approach (n = 43); a theory- and evidence-based approach, e.g. Intervention Mapping, Behaviour Change Wheel (n = 22); or a partnership approach, e.g. community-based participatory research, co-design (n = 10). Ten actions of intervention development were identified from the subset of 30 articles, including identifying a need for an intervention, selecting the intervention development approach to follow, considering the needs of the target population, reviewing published evidence, involving stakeholders, drawing or generating theory, and designing and refining the intervention. Rationales for these actions were that they would produce more engaging, acceptable, feasible, and effective interventions. Conclusions Developers take a variety of approaches to the international endeavour of complex intervention development. We have identified and described a set of actions taken within this endeavour regardless of whether developers follow a published approach or not. Future developers can use these actions and the rationales that underpin them to help them make decisions about the process of intervention development. Trial registration PROSPERO, CRD42017080545.

Abstract Background Type 1 diabetes is a complex chronic condition which requires lifelong treatment with insulin. Health outcomes are dependent on ability to self-manage the condition. Socioeconomic inequalities have been demonstrated in access to treatment and health outcomes for adults with type 1 diabetes; however, there is a paucity of research exploring how these disparities occur. This study explores the influence of socioeconomic factors in gaining access to intensive insulin regimens for adults with type 1 diabetes. Methods We undertook a qualitative descriptive study informed by a phenomenological perspective. In-depth face-to-face interviews were conducted with 28 patients and 6 healthcare professionals involved in their care. The interviews were analysed using a thematic approach. The Candidacy theory for access to healthcare for vulnerable groups framed the analysis. Results Access to intensive insulin regimens was through hospital-based specialist services in this sample. Patients from lower socioeconomic groups had difficulty accessing hospital-based services if they were in low paid work and because they lacked the ability to navigate the healthcare system. Once these patients were in the specialist system, access to intensive insulin regimens was limited by non-alignment with healthcare professional goals, poor health literacy, psychosocial problems and poor quality communication. These factors could also affect access to structured diabetes education which itself improved access to intensive insulin regimens. Contact with diabetes specialist nurses and attendance at structured diabetes education courses could ameliorate these barriers. Conclusions Access to intensive insulin regimens was hindered for people in lower socioeconomic groups by a complex mix of factors relating to the permeability of specialist services, ability to navigate the healthcare system and patient interactions with healthcare providers. Improving access to diabetes specialist nurses and structured diabetes education for vulnerable patients could lessen socioeconomic disparities in both access to services and health outcomes.

Abstract Background Preventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques. Methods Design: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews. Participants: PWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the CF registry. Ineligible: post-lung transplant or on the active list; unable to consent; using dry powder inhalers. Interventions: Central randomisation on a 1:1 allocation to: (1) intervention, linking nebuliser use with data recording and transfer capability to a software platform, and behavioural strategies to support self-management delivered by trained interventionists (n = 32); or, (2) control, typically face-to-face meetings every 3 months with CF team (n = 32). Outcomes: RCT feasibility defined as: recruitment of ≥ 48 participants (75% of target) in four months (pilot primary outcome); valid exacerbation data available for ≥ 85% of those randomised (future RCT primary outcome); change in % medication adherence; FEV1 percent predicted (key secondaries in future RCT); and perceptions of trial procedures, in semi-structured interviews with intervention (n = 14) and control (n = 5) participants, interventionists (n = 3) and CF team members (n = 5). Results The pilot trial recruited to target, randomising 33 to intervention and 31 to control in the four-month period, June–September 2016. At study completion (30th April 2017), 60 (94%; Intervention = 32, Control =28) participants contributed good quality exacerbation data (intervention: 35 exacerbations; control: 25 exacerbation). The mean change in adherence and baseline-adjusted FEV1 percent predicted were higher in the intervention arm by 10% (95% CI: -5.2 to 25.2) and 5% (95% CI -2 to 12%) respectively. Five serious adverse events occurred, none related to the intervention. The mean change in adherence was 10% (95% CI: -5.2 to 25.2), greater in the intervention arm. Interventionists delivered insufficient numbers of review sessions due to concentration on participant recruitment. This left interventionists insufficient time for key intervention procedures. A total of 10 key changes that were made to RCT procedures are summarised. Conclusions With improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible. Trial registration ISRCTN13076797. Prospectively registered on 07/06/2016.

Abstract Background Interventions need to be developed prior to the feasibility and piloting phase of a study. There are a variety of published approaches to developing interventions, programmes or innovations to improve health. Identifying different types of approach, and synthesising the range of actions taken within this endeavour, can inform future intervention development. Methods This study is a systematic methods overview of approaches to intervention development. Approaches were considered for inclusion if they described how to develop or adapt an intervention in a book, website or journal article published after 2007, or were cited in a primary research study reporting the development of a specific intervention published in 2015 or 2016. Approaches were read, a taxonomy of approaches was developed and the range of actions taken across different approaches were synthesised. Results Eight categories of approach to intervention development were identified. (1) Partnership, where people who will use the intervention participate equally with the research team in decision-making about the intervention throughout the development process. (2) Target population-centred, where the intervention is based on the views and actions of the people who will use it. (3) Evidence and theory-based, where the intervention is based on published research evidence and existing theories. (4) Implementation-based, where the intervention is developed with attention to ensuring it will be used in the real world. (5) Efficiency-based, where components of an intervention are tested using experimental designs to select components which will optimise efficiency. (6) Stepped or phased, where interventions are developed with an emphasis on following a systematic set of processes. (7) Intervention-specific, where an approach is constructed for a specific type of intervention. (8) Combination, where existing approaches to intervention development are formally combined. The actions from approaches in all eight categories were synthesised to identify 18 actions to consider when developing interventions. Conclusions This overview of approaches to intervention development can help researchers to understand the variety of existing approaches, and to understand the range of possible actions involved in intervention development, prior to assessing feasibility or piloting the intervention. Findings from this overview will contribute to future guidance on intervention development. Trial registration PROSPERO CRD42017080553.

Objectives To identify the facilitators and barriers to implementing patient-reported outcome measures (PROMs) in third sector organisations (TSOs) delivering health and well-being services.Design A qualitative interview study. Participants were recruited using purposive, opportunistic and snowballing methods. Framework analysis was used.Setting TSOs including charities, community groups and not-for-profit organisations in England, UK.Participants Thirty interviewees including service users, TSO front-line workers and managers, commissioners of TSOs and other stakeholders such as academic researchers.Results TSOs primarily used PROMs because of pressures arising from the external funding context. However, organisations often struggled to implement PROMs, rarely getting the process right first time. Facilitators for implementation included having an implementation lead committed to making it work, investing resources in data management systems and support staff and taking a collaborative approach to designing the PROMs process. The latter helped to ensure an appropriate PROMs process for the specific TSO including choosing a suitable measure and planning how data would be collected, processed and used. There was a dilemma about whether TSOs should use standardised well-being measures (eg, the Warwick-Edinburgh Mental Well-being Scale) or design their own PROM. Not all TSOs sustained the collection and reporting of PROMs over time because this required a change in organisational culture to view PROMs as beneficial for the TSO and PROMs becoming part of front-line workers’ job specifications.Conclusions TSOs are trying to use PROMs because they feel they have no choice but often struggle with implementation. Having an implementation lead, designing an appropriate process, investing resources, training staff and taking mitigating action to address potential barriers can facilitate implementation. Some of the findings are consistent with the experiences of more clinical services so appear relevant to the implementation of PROMs irrespective of the specific context.

Objectives To undertake a process evaluation of an adherence support intervention for people with cystic fibrosis (PWCF), to assess its feasibility and acceptability.Setting Two UK cystic fibrosis (CF) units.Participants Fourteen adult PWCF; three professionals delivering adherence support (‘interventionists’); five multi-disciplinary CF team members.Interventions Nebuliser with data recording and transfer capability, linked to a software platform, and strategies to support adherence to nebulised treatments facilitated by interventionists over 5 months (± 1 month).Primary and secondary measures Feasibility and acceptability of the intervention, assessed through semistructured interviews, questionnaires, fidelity assessments and click analytics.Results Interventionists were complimentary about the intervention and training. Key barriers to intervention feasibility and acceptability were identified. Interventionists had difficulty finding clinic space and time in normal working hours to conduct review visits. As a result, fewer than expected intervention visits were conducted and interviews indicated this may explain low adherence in some intervention arm participants. Adherence levels appeared to be >100% for some patients, due to inaccurate prescription data, particularly in patients with complex treatment regimens. Flatlines in adherence data at the start of the study were linked to device connectivity problems. Content and delivery quality fidelity were 100% and 60%–92%, respectively, indicating that interventionists needed to focus more on intervention ‘active ingredients’ during sessions.Conclusions The process evaluation led to 14 key changes to intervention procedures to overcome barriers to intervention success. With the identified changes, it is feasible and acceptable to support medication adherence with this intervention.Trial registration number ISRCTN13076797; Results.

Introduction Complex population health interventions that are effective in one context may not be effective elsewhere, and may even be harmful. As such, an intervention may require adaptation to ensure it fits with a new context. To date, there is no overarching guidance to help researchers to adapt and evaluate interventions in new contexts, and no criteria to support research funders or journals assess proposed or reported adaptations or evaluation. There is limited assistance for policy-makers and practitioners to decide if evidence-informed interventions are appropriate to their context, or if adaptation and further evaluation is needed. This Delphi exercise will contribute to the development of guidance for these communities to support the adaptation, implementation and/or re-evaluation of complex population health interventions in new contexts.Methods We will conduct a Delphi consensus exercise to gather expert opinion from researchers, research funders, journal editors and policy-makers. Expert opinion will be sought on: appropriate definitions and concepts, identifying key methodological considerations and establishing adaptations and processes to be undertaken during adaptation of complex population health interventions in new contexts.Ethics and dissemination Ethics approval for the Delphi exercise has been obtained from the University of Glasgow and and the RAND institutional research board. Dissemination of the results of this study will be through peer-reviewed publications, workshops at national and international conferences, and a summary of the guidance developed for key organisations and stakeholders.

Background: Front-line health-care services are under increased demand when acute alcohol intoxication is most common, which is in night-time environments. Cities have implemented alcohol intoxication management services to divert the intoxicated away from emergency care. Objectives: To evaluate the effectiveness, cost-effectiveness and acceptability to patients and staff of alcohol intoxication management services and undertake an ethnographic study capturing front-line staff’s views on the impact of acute alcohol intoxication on their professional lives. Methods: This was a controlled mixed-methods longitudinal observational study with an ethnographic evaluation in parallel. Six cities with alcohol intoxication management services were compared with six matched control cities to determine effects on key performance indicators (e.g. number of patients in the emergency department and ambulance response times). Surveys captured the impact of alcohol intoxication management services on the quality of care for patients in six alcohol intoxication management services, six emergency departments with local alcohol intoxication management services and six emergency departments without local alcohol intoxication management services. The ethnographic study considered front-line staff perceptions in two cities with alcohol intoxication management services and one city without alcohol intoxication management services. Results: Alcohol intoxication management services typically operated in cities in which the incidence of acute alcohol intoxication was greatest. The per-session average number of attendances across all alcohol intoxication management services was low (mean 7.3, average minimum 2.8, average maximum 11.8) compared with the average number of emergency department attendances per alcohol intoxication management services session (mean 78.8), and the number of patients diverted away from emergency departments, per session, required for services to be considered cost-neutral was 8.7, falling to 3.5 when ambulance costs were included. Alcohol intoxication management services varied, from volunteer-led first aid to more clinically focused nurse practitioner services, with only the latter providing evidence for diversion from emergency departments. Qualitative and ethnographic data indicated that alcohol intoxication management services are acceptable to practitioners and patients and that they address unmet need. There was evidence that alcohol intoxication management services improve ambulance response times and reduce emergency department attendance. Effects are uncertain owing to the variation in service delivery. Limitations: The evaluation focused on health service outcomes, yet evidence arose suggesting that alcohol intoxication management services provide broader societal benefits. There was no nationally agreed standard operating procedure for alcohol intoxication management services, undermining the evaluation. Routine health data outcomes exhibited considerable variance, undermining opportunities to provide an accurate appraisal of the heterogenous collection of alcohol intoxication management services. Conclusions: Alcohol intoxication management services are varied, multipartner endeavours and would benefit from agreed national standards. Alcohol intoxication management services are popular with and benefit front-line staff and serve as a hub facilitating partnership working. They are popular with alcohol intoxication management services patients and capture previously unmet need in night-time environments. However, acute alcohol intoxication in emergency departments remains an issue and opportunities for diversion have not been entirely realised. The nurse-led model was the most expensive service evaluated but was also the most likely to divert patients away from emergency departments, suggesting that greater clinical involvement and alignment with emergency departments is necessary. Alcohol intoxication management services should be regarded as fledgling services that require further work to realise benefit. Future work: Research could be undertaken to determine if a standardised model of alcohol intoxication management services, based on the nurse practitioner model, can be developed and implemented in different settings. Future evaluations should go beyond the health service and consider outcomes more generally, especially for the police. Future work on the management of acute alcohol intoxication in night-time environments could recognise the partnership between health-care, police and ambulance services and third-sector organisations in managing acute alcohol intoxication. Trial registration: Current Controlled Trials ISRCTN63096364. 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. 24. See the NIHR Journals Library website for further project information.

Objective To improve the quality and consistency of intervention development reporting in health research.Design This was a consensus exercise consisting of two simultaneous and identical three-round e-Delphi studies (one with experts in intervention development and one with wider stakeholders including funders, journal editors and public involvement members), followed by a consensus workshop. Delphi items were systematically derived from two preceding systematic reviews and a qualitative interview study.Participants Intervention developers (n=26) and wider stakeholders (n=18) from the UK, North America and Europe participated in separate e-Delphi studies. Intervention developers (n=13) and wider stakeholders (n=13) participated in a 1-day consensus workshop.Results e-Delphi participants achieved consensus on 15 reporting items. Following feedback from the consensus meeting, the final inclusion and wording of 14 items with description and explanations for each item were agreed. Items focus on context, purpose, target population, approaches, evidence, theory, guiding principles, stakeholder contribution, changes in content or format during the development process, required changes for subgroups, continuing uncertainties, and open access publication. They form the GUIDED (GUIDance for the rEporting of intervention Development) checklist, which contains a description and explanation of each item, alongside examples of good reporting.Conclusions Consensus-based reporting guidance for intervention development in health research is now available for publishers and researchers to use. GUIDED has the potential to lead to greater transparency, and enhance quality and improve learning about intervention development research and practice.

Background: Demand for general practice in the UK is higher than supply. Some patients seek appointments with GPs for minor illnesses rather than self-care. Aim: To identify the characteristics of people with a tendency to contact GPs rather than self-care. Design & setting: A national survey of the British adult population was undertaken in 2018, which included vignettes. Method: Two vignettes focused on illness in adults: half of responders completed a vignette about cough and sore throat for 3 days, and the other half completed a vignette about diarrhoea and vomiting for 2 days. Logistic regression was undertaken to identify characteristics associated with contacting GPs compared with dealing with the problem themselves, calling NHS 111, or contacting another service, including a pharmacist. Results: The response rate was 42%, with 2906 responders. Responders were twice as likely to select ‘contact GP’ for the diarrhoea and vomiting vignette than for the cough and sore throat vignette (44.7% versus 21.8%). Factors associated with tendency for GP contact included being aged >75 years (odds ratio [OR] 2.0, 95% confidence interval [CI] = 1.2 to 3.2); from black, Asian and minority ethnic (BAME) communities (OR 2.1, 95% CI = 1.5 to 3.0); feeling overwhelmed by unexpected health problems (OR 1.4, 95% CI = 0.99 to 2.1); lower health literacy (OR 1.2, 95% CI = 1.0 to 1.4); and believing that general practice is not overused (OR 1.3, 95% CI = 1.1 to 1.7). Conclusion: Type of symptom, personal characteristics, and population beliefs about general practice utilisation explain the tendency to contact GPs for minor illness amenable to self-care.

Background: There is widespread concern about the pressure on emergency and urgent services in the UK, particularly emergency ambulances, emergency departments and same-day general practitioner appointments. A mismatch between supply and demand has led to interest in what can be termed ‘clinically unnecessary’ use of services. This is defined by the research team in this study as ‘patients attending services with problems that are classified as suitable for treatment by a lower urgency service or self-care’. This is a challenging issue to consider because patients may face difficulties when deciding the best action to take, and different staff may make different judgements about what constitutes a legitimate reason for service use. Objectives: To identify the drivers of ‘clinically unnecessary’ use of emergency ambulances, emergency departments and same-day general practitioner appointments from patient and population perspectives. Design: This was a sequential mixed-methods study with three components: a realist review; qualitative interviews (n = 48) and focus groups (n = 3) with patients considered ‘clinically unnecessary’ users of these services, focusing on parents of young children, young adults and people in areas of social deprivation; and a population survey (n = 2906) to explore attitudes towards seeking care for unexpected, non-life-threatening health problems and to identify the characteristics of someone with a tendency for ‘clinically unnecessary’ help-seeking. Results: From the results of the three study components, we found that multiple, interacting drivers influenced individuals’ decision-making. Drivers could be grouped into symptom related, patient related and health service related. Symptom-related drivers were anxiety or need for reassurance, which were caused by uncertainty about the meaning or seriousness of symptoms; concern about the impact of symptoms on daily activities/functioning; and a need for immediate relief of intolerable symptoms, particularly pain. Patient-related drivers were reduced coping capacity as a result of illness, stress or limited resources; fear of consequences when responsible for another person’s health, particularly a child; and the influence of social networks. Health service-related drivers were perceptions or previous experiences of services, particularly the attractions of emergency departments; a lack of timely access to an appropriate general practitioner appointment; and compliance with health service staff’s advice. Limitations: Difficulty recruiting patients who had used the ambulance service to the interviews and focus groups meant that we were not able to add as much as we had anticipated to the limited evidence base regarding this service. Conclusions: Patients use emergency ambulances, emergency departments and same-day general practitioner appointments when they may not need the level of clinical care provided by these services for a multitude of inter-related reasons that sometimes differ by population subgroup. Some of these reasons relate to health services, in terms of difficulty accessing general practice leading to use of emergency departments, and to population-learnt behaviour concerning the positive attributes of emergency departments, rather than to patient characteristics. Social circumstances, such as complex and stressful lives, influence help-seeking for all three services. Demand may be ‘clinically unnecessary’ but completely understandable when service accessibility and patients’ social circumstances are considered. Future work: There is a need to evaluate interventions, including changing service configuration, strengthening general practice and addressing the stressors that have an impact on people’s coping capacity. Different subgroups may require different interventions. Study registration: This study is registered as PROSPERO CRD42017056273. 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. 15. See the NIHR Journals Library website for further project information.

Abstract Background There is increasing interest in using Patient Reported Outcome Measures (PROMs) within organisations delivering health related services. However, organisations have had mixed success in implementing PROMs and there is little understanding about why this may be. Thus, the purpose of this study was to identify the facilitators and barriers to implementing PROMs in organisations. Method A systematic review of reviews was undertaken. Searches were conducted of five electronic databases: MEDLINE, EMBASE, CINAHL, PsycINFO and the Cochrane Database of Systematic Reviews, during the week of the 20th February 2017. Additional search methods included website searching and reference checking. To be included, a publication had to be a review of the literature, describe its methods and include information related to implementing PROMs. The reviews were extracted using a standardised form and assessed for their risk of bias using the Risk of Bias in Systematic Reviews tool. The findings were synthesised using the Consolidated Framework for Implementation Research. The protocol was registered on the International Prospective Register of Systematic Reviews database (PROSPERO) (CRD42017057491). Results Initially 2047 records were identified. After assessing eligibility, six reviews were included. These reviews varied in their review type and focus. Different issues arose at distinct stages of the implementation process. Organisations needed to invest time and resources in two key stages early in the implementation process: ‘designing’ the processes for using PROMs within an organisation; and ‘preparing’ an organisation and its staff. The ‘designing’ stage involved organisations planning not just which PROMs to use and how to administer them, but also how the data would be used for clinical purposes. The ‘preparing’ stage involved getting an organisation and its staff ready to use PROMs, particularly persuading clinicians of the validity and value of PROMs, delivering training, and developing electronic systems. Having an implementation lead overseeing the process and developing the process based on feedback were also identified as facilitating implementation. Conclusion Organisations implementing PROMs need to invest time and resources in ‘designing’ the PROMs strategy and ‘preparing’ the organisation to use PROMs. Focusing on these earlier stages may prevent problems arising when PROMs are used in practice.

Abstract Background People with intellectual disabilities (ID) may not be able to access and respond to uniformly delivered health interventions. Public bodies have a legal duty to make ‘reasonable adjustments’ to policies and practices to provide fair access and treatment for people with ID. This study aimed to identify adjustments to the Slimming World weight management programme to improve accessibility and assess acceptability and feasibility for this population. Methods This user-centred qualitative study was carried out with a steering group of people with ID (n = 4). Barriers and facilitators to using Slimming World were identified through interviews and focus groups with people with ID (n = 54), carers (n = 12) current members with ID (n = 8) and Slimming World group leaders (n = 11). Adjustments were made and their feasibility and acceptability were explored in a before-and-after mixed methods study where people with ID attended Slimming World for eight weeks. Participants (n = 9), carers (n = 7) and Slimming World group leaders (n = 4) were interviewed to explore their experiences of the adjustments. Participants were weighed at baseline then each week. Results Four key adjustments were identified and addressed by Slimming World who developed prototype Easy Read materials and a letter for carers. Six of the nine participants attended Slimming World for eight weeks and lost weight (1.4 kg to 6.6 kg, reduction in BMI between 0.5 and 1.7 kg/m2), indicating that the adjustments were feasible and acceptable. Two participants dropped out because they felt uncomfortable in a mainstream group and another left because they lacked control over food choice in their residential setting. Conclusions This user-centred approach identified reasonable adjustments that were feasible to implement. In a small uncontrolled feasibility study, people with ID were positive about the adjustments and lost weight. However, issues in the wider context of people’s lives, such as obesogenic environments and concerns about joining mainstream groups, limited the acceptability of Slimming World even with these adjustments. These findings have important implications for policy and suggest that environmental and organisational level interventions are needed alongside those targeting individual behaviour to tackle the obesogenic environment in which many people with ID spend their time, in order to reduce inequalities associated with the consequences of obesity.

Background: Ambulance service quality measures have focused on response times and a small number of emergency conditions, such as cardiac arrest. These quality measures do not reflect the care for the wide range of problems that ambulance services respond to and the Prehospital Outcomes for Evidence Based Evaluation (PhOEBE) programme sought to address this. Objectives: The aim was to develop new ways of measuring the impact of ambulance service care by reviewing and synthesising literature on prehospital ambulance outcome measures and using consensus methods to identify measures for further development; creating a data set linking routinely collected ambulance service, hospital and mortality data; and using the linked data to explore the development of case-mix adjustment models to assess differences or changes in processes and outcomes resulting from ambulance service care. Design: A mixed-methods study using a systematic review and synthesis of performance and outcome measures reported in policy and research literature; qualitative interviews with ambulance service users; a three-stage consensus process to identify candidate indicators; the creation of a data set linking ambulance, hospital and mortality data; and statistical modelling of the linked data set to produce novel case-mix adjustment measures of ambulance service quality. Setting: East Midlands and Yorkshire, England. Participants: Ambulance services, patients, public, emergency care clinical academics, commissioners and policy-makers between 2011 and 2015. Interventions: None. Main outcome measures: Ambulance performance and quality measures. Data sources: Ambulance call-and-dispatch and electronic patient report forms, Hospital Episode Statistics, accident and emergency and inpatient data, and Office for National Statistics mortality data. Results: Seventy-two candidate measures were generated from systematic reviews in four categories: (1) ambulance service operations (n = 14), (2) clinical management of patients (n = 20), (3) impact of care on patients (n = 9) and (4) time measures (n = 29). The most common operations measures were call triage accuracy; clinical management was adherence to care protocols, and for patient outcome it was survival measures. Excluding time measures, nine measures were highly prioritised by participants taking part in the consensus event, including measures relating to pain, patient experience, accuracy of dispatch decisions and patient safety. Twenty experts participated in two Delphi rounds to refine and prioritise measures and 20 measures scored ≥ 8/9 points, which indicated good consensus. Eighteen patient and public representatives attending a consensus workshop identified six measures as important: time to definitive care, response time, reduction in pain score, calls correctly prioritised to appropriate levels of response, proportion of patients with a specific condition who are treated in accordance with established guidelines, and survival to hospital discharge for treatable emergency conditions. From this we developed six new potential indicators using the linked data set, of which five were constructed using case-mix-adjusted predictive models: (1) mean change in pain score; (2) proportion of serious emergency conditions correctly identified at the time of the 999 call; (3) response time (unadjusted); (4) proportion of decisions to leave a patient at scene that were potentially inappropriate; (5) proportion of patients transported to the emergency department by 999 emergency ambulance who did not require treatment or investigation(s); and (6) proportion of ambulance patients with a serious emergency condition who survive to admission, and to 7 days post admission. Two indicators (pain score and response times) did not need case-mix adjustment. Among the four adjusted indicators, we found that accuracy of call triage was 61%, rate of potentially inappropriate decisions to leave at home was 5–10%, unnecessary transport to hospital was 1.7–19.2% and survival to hospital admission was 89.5–96.4% depending on Clinical Commissioning Group area. We were unable to complete a fourth objective to test the indicators in use because of delays in obtaining data. An economic analysis using indicators (4) and (5) showed that incorrect decisions resulted in higher costs. Limitations: Creation of a linked data set was complex and time-consuming and data quality was variable. Construction of the indicators was also complex and revealed the effects of other services on outcome, which limits comparisons between services. Conclusions: We identified and prioritised, through consensus processes, a set of potential ambulance service quality measures that reflected preferences of services and users. Together, these encompass a broad range of domains relevant to the population using the emergency ambulance service. The quality measures can be used to compare ambulance services or regions or measure performance over time if there are improvements in mechanisms for linking data across services. Future work: The new measures can be used to assess different dimensions of ambulance service delivery but current data challenges prohibit routine use. There are opportunities to improve data linkage processes and to further develop, validate and simplify these measures. Funding: The National Institute for Health Research Programme Grants for Applied Research programme.

BackgroundGuidance and frameworks exist to assist those developing health interventions but may offer limited discussion of 'design', the part of development concerned with generating ideas for and making decisions about an intervention's content, format and delivery. The aim of this paper is to describe and understand the views and experiences of developers and associated stakeholders in relation to how design occurs in health intervention development.MethodsSemi-structured interviews were conducted with 21 people who had developed complex interventions to improve health and/or who were relevant stakeholders (e.g. funders and publishers of intervention development work), regarding their views, experiences and approaches to intervention design. Sampling was purposive in terms of maximising diversity. A thematic inductive analysis was conducted.ResultsApproaches to design varied substantially between intervention developers. This contrasted with consistency in other activities undertaken during development, such as literature review. Design also posed more challenges than other parts of development. We identified six 'modes' of design: informed; negotiated; structured; delegated; 'my baby'; and creative partnership. In understanding the differences between these different modes, and the challenges posed by intervention design, we identified three key themes: enabling creativity during the design process; working with different types of knowledge; and 'stabilising' (developing clear shared understandings of) the intervention development to enable design.ConclusionsDesign has received less attention than other activities undertaken when developing interventions to improve health. Developers take a variety of approaches to design and often find it challenging. Guidance for intervention development in health has tended to see design as proceeding in a predictable and controlled manner from acquired knowledge. Our study suggests that design rarely reflects this rational ideal. Future guidance on intervention development in healthcare should support developers to work effectively with different types of knowledge, to help design progress more smoothly and to maximise creativity.

International government guidance recommends patient and public involvement (PPI) to improve the relevance and quality of research. PPI is defined as research being carried out ‘with’ or ‘by’ patients and members of the public rather than ‘to’, ‘about’ or ‘for’ them (http://www.invo.org.uk/). Patient involvement is different from collecting data from patients as participants. Ethical considerations also differ. PPI is about patients actively contributing through discussion to decisions about research design, acceptability, relevance, conduct and governance from study conception to dissemination. Occasionally patients lead or do research. The research methods of PPI range from informal discussions to partnership research approaches such as action research, co-production and co-learning. This article discusses how researchers can involve patients when they are applying for research funding and considers some opportunities and pitfalls. It reviews research funder requirements, draws on the literature and our collective experiences as clinicians, patients, academics and members of UK funding panels.

Background: In England in 2015/16, ambulance services responded to nearly 11 million calls. Ambulance Quality Indicators show that half of the patients receiving a response by telephone or face to face were not conveyed to an emergency department. A total of 11% of patients received telephone advice only. A total of 38% of patients were sent an ambulance but were not conveyed to an emergency department. For the 10 large ambulance services in England, rates of calls ending in telephone advice varied between 5% and 17%. Rates of patients who were sent an ambulance but not conveyed to an emergency department varied between 23% and 51%. Overall non-conveyance rates varied between 40% and 68%. Objective: To explain variation in non-conveyance rates between ambulance services. Design: A sequential mixed methods study with five work packages. Setting: Ten of the 11 ambulance services serving > 99% of the population of England. Methods: (1) A qualitative interview study of managers and paramedics from each ambulance service, as well as ambulance commissioners (totalling 49 interviews undertaken in 2015). (2) An analysis of 1 month of routine data from each ambulance service (November 2014). (3) A qualitative study in three ambulance services with different published rates of calls ending in telephone advice (120 hours of observation and 20 interviews undertaken in 2016). (4) An analysis of routine data from one ambulance service linked to emergency department attendance, hospital admission and mortality data (6 months of 2013). (5) A substudy of non-conveyance for people calling 999 with breathing problems. Results: Interviewees in the qualitative study identified factors that they perceived to affect non-conveyance rates. Where possible, these perceptions were tested using routine data. Some variation in non-conveyance rates between ambulance services was likely to be due to differences in the way rates were calculated by individual services, particularly in relation to telephone advice. Rates for the number of patients sent an ambulance but not conveyed to an emergency department were associated with patient-level factors: age, sex, deprivation, time of call, reason for call, urgency level and skill level of attending crew. However, variation between ambulance services remained after adjustment for patient-level factors. Variation was explained by ambulance service-level factors after adjustment for patient-level factors: the percentage of calls attended by advanced paramedics [odds ratio 1.05, 95% confidence interval (CI) 1.04 to 1.07], the perception of ambulance service staff and commissioners that advanced paramedics were established and valued within the workforce of an ambulance service (odds ratio 1.84, 95% CI 1.45 to 2.33), and the perception of ambulance service staff and commissioners that senior management was risk averse regarding non-conveyance within an ambulance service (odds ratio 0.78, 95% CI 0.63 to 0.98). Limitations: Routine data from ambulance services are complex and not consistently collected or analysed by ambulance services, thus limiting the utility of comparative analyses. Conclusions: Variation in non-conveyance rates between ambulance services in England could be reduced by addressing variation in the types of paramedics attending calls, variation in how advanced paramedics are used and variation in perceptions of the risk associated with non-conveyance within ambulance service management. Linking routine ambulance data with emergency department attendance, hospital admission and mortality data for all ambulance services in the UK would allow comparison of the safety and appropriateness of their different non-conveyance rates. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

BackgroundSome patients calling ambulance services (known as Emergency Medical Services internationally) are not transported to hospital. In England, national ambulance quality indicators show considerable variation in non-transport rates between the ten large regional ambulance services. The aim of this study was to explain variation between ambulance services in two types of non-transport: discharge at scene and telephone advice.MethodsMixed model logistic regressions using one month of data (November 2014) from the Computer Aided Despatch systems of the ten large regional ambulance services in England.Results41% (251 677/615 815) of patients calling ambulance services were not transported to hospital. Most were discharged at scene after attendance by an ambulance (29% n = 182 479) and a small percentage were given telephone advice (7% n = 40 679). Discharge at scene rates varied by patient-level factors e.g. they were higher for elderly patients, where the reason for calling was falls, and for patients attended by paramedics with extended skills. These patient-level factors did not explain variation between ambulance services. After adjustment for patient-level factors, the following ambulance service level factors explained variation in discharge at scene rates: proportion of patients attended by paramedics with extended skills (odds ratio 1.05 (95% CI 1.04, 1.07)), the perception of ambulance service staff that paramedics with extended skills were established and valued within the workforce (odds ratio 1.84 (1.45, 2.33), and the perception of ambulance service staff that senior management viewed non-transport as risky (odds ratio 0.78 (0.63, 0.98)). Variation in telephone advice rates could not be explained.ConclusionsVariation in discharge at scene rates was explained by differences in workforce configuration and managerial motivation, factors that are largely modifiable by ambulance services.

AIMS:To systematically review the evidence of socioeconomic inequalities for adults with type 1 diabetes in relation to mortality, morbidity and diabetes management. METHODS:We carried out a systematic search across six relevant databases and included all studies reporting associations between socioeconomic indicators and mortality, morbidity, or diabetes management for adults with type 1 diabetes. Data extraction and quality assessment was undertaken for all included studies. A narrative synthesis was conducted. RESULTS:A total of 33 studies were identified. Twelve cohort, 19 cross sectional and 2 case control studies met the inclusion criteria. Regardless of healthcare system, low socioeconomic status was associated with poorer outcomes. Following adjustments for other risk factors, socioeconomic status was a statistically significant independent predictor of mortality in 9/10 studies and morbidity in 8/10 studies for adults with type 1 diabetes. There appeared to be an association between low socioeconomic status and some aspects of diabetes management. Although only 3 of 16 studies made adjustments for confounders and other risk factors, poor diabetes management was associated with lower socioeconomic status in 3/3 of these studies. CONCLUSIONS:Low socioeconomic status is associated with higher levels of mortality and morbidity for adults with type 1 diabetes even amongst those with access to a universal healthcare system. The association between low socioeconomic status and diabetes management requires further research given the paucity of evidence and the potential for diabetes management to mitigate the adverse effects of low socioeconomic status.

Background: Health services internationally are exploring the potential of telehealth to support the management of the growing number of people with long-term conditions (LTCs). Aim: To develop, implement and evaluate new care programmes for patients with LTCs, focusing on two common LTCs as exemplars: depression or high cardiovascular disease (CVD) risk. Methods Development: We synthesised quantitative and qualitative evidence on the effectiveness of telehealth for LTCs, conducted a qualitative study based on interviews with patients and staff and undertook a postal survey to explore which patients are interested in different forms of telehealth. Based on these studies we developed a conceptual model [TElehealth in CHronic disease (TECH) model] as a framework for the development and evaluation of the Healthlines Service for patients with LTCs. Implementation: The Healthlines Service consisted of regular telephone calls to participants from health information advisors, supporting them to make behaviour change and to use tailored online resources. Advisors sought to optimise participants’ medication and to improve adherence. Evaluation: The Healthlines Service was evaluated with linked pragmatic randomised controlled trials comparing the Healthlines Service plus usual care with usual care alone, with nested process and economic evaluations. Participants were adults with depression or raised CVD risk recruited from 43 general practices in three areas of England. The primary outcome was response to treatment and the secondary outcomes included anxiety (depression trial), individual risk factors (CVD risk trial), self-management skills, medication adherence, perceptions of support, access to health care and satisfaction with treatment. Trial results Depression trial: In total, 609 participants were randomised and the retention rate was 86%. Response to treatment [Patient Health Questionnaire 9-items (PHQ-9) reduction of ≥ 5 points and score of

Background: Recent increases in emergency admission rates have caused concern. Some emergency admissions may be avoidable if services in the emergency and urgent care system are available and accessible. A set of 14 conditions, likely to be rich in avoidable emergency admissions, was identified by expert consensus. Objective: We aimed to understand variation in avoidable emergency admissions between different emergency and urgent care systems in England. Methods: The design was a sequential mixed-methods study in three phases. In phase 1 we calculated an age- and sex-adjusted avoidable admission rate for 2008–11. We located routine data on characteristics of emergency and urgent care systems and used linear regression to explain variation in avoidable admissions rates in 150 systems. In phase 2 we undertook in-depth case studies in six systems to identify further factors. A key part of these case studies was interviews with commissioners, service providers and patient representatives, totalling 82 interviews. In phase 3 we returned to the linear regression to test further factors identified in the case studies. Results: The 14 conditions accounted for 3,273,395 admissions in 2008–11 (22% of all emergency admissions). The mean age- and sex-adjusted admission rate was 2258 per year per 100,000 population, with a 3.4-fold variation between systems (1268–4359). Characteristics of the population explained the majority of variation: deprivation explained 72% of variation, with urban/rural status explaining 3% more. Systems serving populations with high levels of deprivation and in urban areas had high rates of potentially avoidable admissions. Interviewees described the complexity of deprivation, representing high levels of morbidity, low awareness of alternative services to emergency departments and high expressed need for immediate access to urgent care. Factors related to emergency departments (EDs), hospitals, emergency ambulance services and general practice explained a further 10% of variation in avoidable admissions. Systems with high, potentially avoidable, admission rates had high rates of acute beds (suggesting supply-induced demand), high rates of attendance at EDs (which have been associated with poor perceived access to general practice), high rates of conversion from ED attendances to admissions, and low rates of non-transport to emergency departments by emergency ambulances. The six case studies revealed further possible explanations of variation: there was variation in how hospitals coded admissions; some systems focused proactively on admission avoidance whereas others were more interested in hospital discharge, for example use of multidisciplinary teams based at acute trusts; there were different levels of integration between different services such as health and social care, and acute and community trusts; and some systems faced more challenging problems around geographical boundaries operating for different services in the system. Interviewees often described admission as the easy or safe option. Conclusions: Deprivation explained most of the variation in avoidable admission rates. Research is needed to understand the complex relationship between deprivation and avoidable admission, and to develop interventions tailored to avoid admissions from deprived communities. Standardisation of coding of admissions would reduce variation. Funding: The National Institute for Health Research Health Service and Research Delivery programme.

Background: Generic preference-based measures of health like the EQ-5D and SF-6D® are increasingly being used in economic evaluation and outcome assessment. However, there are concerns as to whether or not these generic measures are appropriate for use in people with mental health problems. Objectives: The EQ-5D and SF-36® (including its derivatives the SF-12® and SF-6D) were assessed using the psychometric criteria of validity and responsiveness using quantitative and qualitative methods. Another aim was to estimate mapping functions between the EQ-5D and SF-6D and condition-specific measures, where appropriate. Design: Four studies were undertaken to examine the appropriateness of the measures: (1) a systematic review of quantitative evidence on validity and responsiveness; (2) a further quantitative assessment of these criteria using existing data sets; (3) a review of qualitative research on the quality of life of people with mental health problems; and (4) qualitative semistructured interviews of people with a full range of problems. A fifth study estimated mapping functions between mental health-specific measures and the EQ-5D and SF-6D. Setting: A choice of venue was offered for the interviews including the participant’s own home, a room at the university or a centre frequently used by mental health services. Participants: The interviews were undertaken with 19 people with a broad range of mental health problems at varying levels of severity. Main outcome measures: The reviews included the EQ-5D and SF-36 (and the SF-12 and SF-6D). The psychometric analysis included the Hospital Anxiety and Depression Scale (HADS), Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM), Generalised Anxiety Disorder Assessment (GAD-7), General Health Questionnaire (GHQ-12) and Patient Health Questionnaire (PHQ-9). Results: (1) and (2) The EQ-5D and SF-36 achieved an adequate level of performance in depression, and to some extent in anxiety and personality disorder. Results from the psychometric analyses in schizophrenia and bipolar disorder have been more mixed. (3) A framework analysis of 13 studies identified six major themes. (4) The interview data fitted the themes from the review well and resulted in minor modifications to the themes. The final set of themes comprised: well-being and ill-being; control, autonomy and choice; self-perception; belonging; activity; hope and hopelessness; and physical health. Conclusions: The EQ-5D and SF-36 achieved mixed results in the quantitative testing against psychometric criteria. The qualitative analysis suggests this is because they provide a very limited coverage of themes identified by people with mental health problems. Recommendations for future work include the development of new preference-based measures in mental health that are based on, or substantially revise, an existing measure. Funding: The Medical Research Council.

International government guidance recommends patient and public involvement (PPI) to improve the relevance and quality of research. PPI is defined as research being carried out ‘with’ or ‘by’ patients and members of the public rather than ‘to’, ‘about’ or ‘for’ them ( http://www.invo.org.uk/). Patient involvement is different from collecting data from patients as participants. Ethical considerations also differ. PPI is about patients actively contributing through discussion to decisions about research design, acceptability, relevance, conduct and governance from study conception to dissemination. Occasionally patients lead or do research. The research methods of PPI range from informal discussions to partnership research approaches such as action research, co-production and co-learning. This article discusses how researchers can involve patients when they are applying for research funding and considers some opportunities and pitfalls. It reviews research funder requirements, draws on the literature and our collective experiences as clinicians, patients, academics and members of UK funding panels.