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Populations around the world are rapidly ageing and more people are living with multiple long-term conditions. There is an urgent need for evidence about high quality, cost-effective, and integrated systems of health and social care. Health research funders are now also prioritising research in adult social care and wider local authority settings, e.g. housing services. Developing the evidence base for adult social care should include implementing randomised controlled trials, where appropriate. Within the UK, the clinical trial is the established road map for evaluating interventions in the National Health Service (NHS). However, adult social care and local authorities are relatively uncharted territory for trials. BATH-OUT-2 is one of the first clinical trials currently underway within adult social care and housing adaptations services in six English local authorities. It provides an opportunity to explore how the clinical trial road map fares in these settings. Whilst setting up BATH-OUT-2, we encountered challenges with securing funding for the trial, lack of non-NHS intervention costs, using research and support costs as intended, gaining approvals, identifying additional trial sites, and including people who lack the mental capacity to provide informed consent. Overall, our experience has been like navigating uncharted territory with a borrowed map. In the UK, the clinical trial road map was developed for medical settings. Its key features are integrated within the NHS landscape but have been largely absent, unfamiliar, inaccessible, or irrelevant in social care and wider local authority terrain. Navigating the set-up of a clinical trial outside the NHS has been a complicated and disorientating journey. BATH-OUT-2 highlights how local authorities generally and adult social care specifically are a relatively new and certainly different type of setting for trials. Whilst this poses a challenge for conducting trials, it also presents an opportunity to question longstanding assumptions within trials practices, reimagine the conventional clinical trial road map, and take it in new directions. As the UK research landscape moves forward and becomes better primed for randomised evaluations in local authorities, we propose several suggestions for building on recent progress and advancing trials within adult social care and across health and care systems. [ABSTRACT FROM AUTHOR]

A crisis in social care is apparent across the developed world as ageing populations put unprecedented demand on understaffed social care workforces. A recent popular response to this 'care crisis' within the UK involves the 'innovation' of single‐handed care (SHC). SHC involves a care package with two or more homecare workers being reduced to one worker using advanced equipment and new moving and handling techniques. In this article, we explore how SHC is rendered in 245 documents from 52 local authorities in England. Using Actor Network Theory as an interpretative lens, we suggest documents attempt to satisfy three 'duties of care': to the individual wellbeing of citizens, morally and fiscally to the collective and to innovation. Each appeal to different stakeholder groups necessary for SHC to work, but the combination of duties can pose problems in enabling coherent stories of SHC. Duties can be kept apart in different documents, but at times they must be brought together in certain textual spaces to enact SHC as a coherent enterprise. Here, the potential tensions that emerge are routinely orientated to as (merely) problems of process that can and should be managed in and through a more refined approach to change management. [ABSTRACT FROM AUTHOR]

Background: Randomised controlled trials of non-pharmacological interventions in children's therapy are rare. This is, in part, due to the challenges of the acceptability of common trial designs to therapists and service users. This study investigated the acceptability of participation in cluster randomised controlled trials to therapists and service users.Methods: A national electronic survey of UK occupational therapists, physiotherapists, speech and language therapists, service managers, and parents of children who use their services. Participants were recruited by NHS Trusts sharing a link to an online questionnaire with children's therapists in their Trust and with parents via Trust social media channels. National professional and parent networks also recruited to the survey. We aimed for a sample size of 325 therapists, 30 service managers, and 60 parents. Trial participation was operationalised as three behaviours undertaken by both therapists and parents: agreeing to take part in a trial, discussing a trial, and sharing information with a research team. Acceptability of the behaviours was measured using an online questionnaire based on the Theoretical Framework of Acceptability constructs: affective attitude, self-efficacy, and burden. The general acceptability of trials was measured using the acceptability constructs of intervention coherence and perceived effectiveness. Data were collected from June to September 2020. Numerical data were analysed using descriptive statistics and textual data by descriptive summary.Results: A total of 345 survey responses were recorded. Following exclusions, 249 therapists and 40 parents provided data which was 69.6% (289/415) of the target sample size. It was not possible to track the number of people invited to take the survey nor those who viewed, but did not complete, the online questionnaire for calculation of response rates. A completion rate (participants who completed the last page of the survey divided by the participants who completed the first, mandatory, page of the survey) of 42.9% was achieved. Of the three specified trial behaviours, 140/249 (56.2%) therapists were least confident about agreeing to take part in a trial. Therapists (135/249, 52.6%) reported some confidence they could discuss a trial with a parent and child at an appointment. One hundred twenty of 249 (48.2%) therapists reported confidence in sharing information with a research team through questionnaires and interviews or sharing routine health data. Therapists (140/249, 56.2%) felt that taking part in the trial would take a lot of effort and resources. Support and resources, confidence with intervention allocation, and sense of control and professional autonomy over clinical practice were factors that positively affected the acceptability of trials. Of the 40 parents, twelve provided complete data. Most parents (18/40, 45%) agreed that it was clear how trials improve children's therapies and outcomes and that a cluster randomised trial made sense to them in their therapy situation (12/29, 30%).Conclusions: Using trials to evaluate therapy interventions is, in principle, acceptable to therapists, but their willingness to participate in trials is variable. The willingness to participate may be particularly influenced by their views related to the burden associated with trials, intervention allocation, and professional autonomy. [ABSTRACT FROM AUTHOR]

Background Aim Design Data Sources Results Conclusion Implications for the Profession and/or Patient Care Patient or Public Contribution Venous leg ulcers affect 1.5% of the UK adult population. Leg ulcers are painful, can be malodourous and are associated with poor quality of life. Leg ulcers are predominantly cared for by nurses in the community. Frequently, patients receive suboptimal treatment through unwanted variations in care and simple ulcers deteriorate to become hard‐to‐heal wounds. It is important to understand the current UK system of care and how nurses and patients navigate through it.The aim of this paper was to understand how, when, for whom and in what context leg ulcers are cared for in the United Kingdom and specifically, the current system of care, the nurses' role and the patients' experience in this system of care.A realist synthesis of the literature was undertaken, reported following the RAMESES publication standards: Realist syntheses.An iterative literature search was conducted across three recognized health collections from January 2010 to January 2022 that included descriptive studies as well as primary research.73 papers were included.In the absence of UK national guidance that recommends how leg ulcer care is organized and delivered, care is commissioned locally, with variable outcomes. Patients with venous leg ulcers would like to be looked after by knowledgeable, skilled and confident nurses, in well‐equipped and staffed clinics; nurses who have the ability to make clinical judgements to alter their treatment when necessary and are empowered to refer to specialist centres when further support is required.This synthesis offers guidance to commissioners and providers to change how leg ulcer care is organized.The views of a patient and public group was sought at each stage of the synthesis. [ABSTRACT FROM AUTHOR]

Background: Many children and young people with juvenile idiopathic arthritis (JIA) experience delay in diagnosis and access to right care. The reasons for delay are multi-factorial and influenced by patient and family, clinician and organisational factors. Our aim was to explore the experiences of care, from initial symptoms to initial referral to paediatric rheumatology. Methods: We analysed one-to-one and joint qualitative interviews with families of children with JIA (n = 36) presenting to a regional paediatric rheumatology service in the UK. We interviewed 51 family members (including mothers, fathers, patients, grandmothers and an aunt) and 10 health professionals (including orthopaedic surgeons, paediatricians, paediatric immunologist, General Practitioner and nurse) and a teacher involved in the care pathway of these JIA patients. Interviews were audio-recorded and analysed according to the standard procedures of rigorous qualitative analysis - coding, constant comparison, memoing and deviant case analysis. Results: The median age of the children was 6 years old (range 1–17), with a spread of JIA subtypes. The median reported time to first PRh MDT visit from symptom onset was 22 weeks (range 4-364 weeks). Three key factors emerged in the pathways to appropriate care: (i) the persistence of symptoms (e.g. 'change' such as limp or avoidance of previously enjoyed activities); (ii) the persistence of parents help-seeking actions (e.g. repeat visits to primary and hospital care with concern that their child is not 'normal'; iii) the experience and skills of health professionals resulting in different trajectories (e.g. no-real-concern-at-this-point or further-investigation-is-required). JIA was more likely to be considered amongst health practitioner if they had prior experiences of a child with JIA (moreso with a 'protracted pathway') or exposure to paediatric rheumatology in their training. Conversely JIA was more likely to be overlooked if the child had comorbidity such as learning disability or a chronic illness. Conclusions: Care pathways are often 'turbulent' prior to a diagnosis of JIA with physical and emotional distress for families. There is need for greater awareness about JIA amongst health care professionals and observations of change (from family and non-health care professionals such as teachers) are key to trigger referral for paediatric rheumatology opinion. [ABSTRACT FROM AUTHOR]

There is increasing global attention on the health and wellbeing needs of young people. Preventive and proactive approaches will likely lead to the clearest dividends for young people, their own children and wider society. A brief overview of the international context for young people's health care is given. As well as influencing policy, there are important roles for the health care team, including psychologists, to influence the organisations they work within, advocating for the needs of young people and their families. This is the focus of this article. The concept of developmentally appropriate health care (DAH) for young people is explored. It could help when planning services and approaches that respond to the needs of young people. Building relationships is likely to be key, to connect with young people to help them make health and wellbeing decisions, and provide individualised support. The 'connectedness' research could also be helpful in looking beyond the health care evidence. A key challenge for psychologists and their multi-disciplinary health care colleagues, in practice and research, is to move away from a reliance on binary, easier-to-measure health and wellbeing outcomes and, instead, find ways to promote and measure developmental outcomes that are meaningful to young people and their families. [ABSTRACT FROM AUTHOR]

Background During transition from children's to adults' healthcare, young adults with long-term conditions may show delays in psychosocial development compared to their peers without long-term conditions, and deterioration of their conditions' medical control. Methods This paper integrates the findings, already published in 10 separate papers, of a 5-year transition research programme. Implications There is an important role for funders (commissioners) of adults' services to fund transitional healthcare, in addition to funders of children's services who currently take responsibility. It is important that healthcare provider organisations adopt an organisation-wide approach to implementation to ensure that good practice is adopted in children's and adults' services, not just adopted by enthusiasts in some special- ties. This includes provision of 'developmentally appropriate healthcare' which recognises the changing biopsychosocial developmental needs of young people. Three features of transitional healthcare were associated with improved outcomes: appropriate parent involvement, promotion of young people's confidence in managing their health and meeting the adult team before transfer. These should be maintained or introduced as a priority. Child and adult healthcare providers should routinely explore with a young person how they approach transition and personalise their clinical approach thereafter. These implications are relevant for a range of stakeholders, including funders of transitional healthcare, organisations providing transitional healthcare and clinical practitioners. [ABSTRACT FROM AUTHOR]

Patient and public involvement in research includes non‐academics working with researchers, on activities from consultative tasks, to joint working, and on user‐led initiatives. Health and social care funding bodies require involvement in research projects. A current debate focuses on a perceived lack of empirical "proof" to demonstrate the impact of involvement upon the quality of research. It is also argued that the working relationships between researchers and those becoming involved need to be understood more fully. These areas are beginning to be reported upon but there are few studies of young people involved in health research. This study describes the experiences of adult academics and young people, working together on a large‐scale, UK health research programme. Using qualitative interview and focus group methods, the aim was to explore participants' perceptions about the process and outcomes of their work together. The importance of cyclical, dynamic and flexible approaches is suggested. Enablers include having clear mechanisms for negotiation and facilitation, stakeholders having a vision of "the art of the possible," and centrally, opportunities for face‐to‐face working. What is needed is a continuing discourse about the challenges and benefits of working with young people, as distinct from younger children and adults, understanding the value of this work, without young people having to somehow "prove" themselves. Involvement relies on complex social processes. This work supports the view that an improved understanding of how key processes are enabled, as well as what involvement achieves, is now needed. [ABSTRACT FROM AUTHOR]

Background: Understanding and measuring implementation processes is a key challenge for implementation researchers. This study draws on Normalization Process Theory (NPT) to develop an instrument that can be applied to assess, monitor or measure factors likely to affect normalization from the perspective of implementation participants.Methods: An iterative process of instrument development was undertaken using the following methods: theoretical elaboration, item generation and item reduction (team workshops); item appraisal (QAS-99); cognitive testing with complex intervention teams; theory re-validation with NPT experts; and pilot testing of instrument.Results: We initially generated 112 potential questionnaire items; these were then reduced to 47 through team workshops and item appraisal. No concerns about item wording and construction were raised through the item appraisal process. We undertook three rounds of cognitive interviews with professionals (n = 30) involved in the development, evaluation, delivery or reception of complex interventions. We identified minor issues around wording of some items; universal issues around how to engage with people at different time points in an intervention; and conceptual issues around the types of people for whom the instrument should be designed. We managed these by adding extra items (n = 6) and including a new set of option responses: 'not relevant at this stage', 'not relevant to my role' and 'not relevant to this intervention' and decided to design an instrument explicitly for those people either delivering or receiving an intervention. This version of the instrument had 53 items. Twenty-three people with a good working knowledge of NPT reviewed the items for theoretical drift. Items that displayed a poor alignment with NPT sub-constructs were removed (n = 8) and others revised or combined (n = 6). The final instrument, with 43 items, was successfully piloted with five people, with a 100% completion rate of items.Conclusion: The process of moving through cycles of theoretical translation, item generation, cognitive testing, and theoretical (re)validation was essential for maintaining a balance between the theoretical integrity of the NPT concepts and the ease with which intended respondents could answer the questions. The final instrument could be easily understood and completed, while retaining theoretical validity. NoMAD represents a measure that can be used to understand implementation participants' experiences. It is intended as a measure that can be used alongside instruments that measure other dimensions of implementation activity, such as implementation fidelity, adoption, and readiness. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: Parent‐delivered therapy interventions for children with cerebral palsy can help achieve a sufficient therapy dose, improve parental mental well‐being, and facilitate parent–child relationships creating a more relaxed familial environment. However, parent‐delivered interventions may also lead to increased parental stress, guilt if the therapy is not delivered, and time constraints. The primary aim of this review was to gain a deeper understanding of the determinants of effective parent‐delivered therapy interventions. Method: Searches were conducted in the following databases: Medline, PubMed, Scopus, Embase, CINAHL, and Cochrane. Studies had to meet the following inclusion criteria: descriptions of parent/health care professional/child experiences of parent‐delivered therapy interventions for children and young people age 0–18 years with cerebral palsy, published in the English language between January 1989 and May 2017, with qualitative or mixed methods research design. The articles were critically appraised, then synthesized using a meta‐ethnographic approach. Results: A literature search identified 17 articles, which met the inclusion criteria. Three main themes were identified: (a) building trusting relationships, (b) enabling the parents to cope, and (c) for parents and health care professionals to see the intervention as a priority. Further synthesis presented three concepts identifying the important aspects of the interventions: empowerment, motivation, and relationships. Conclusions: The themes and concepts emerging from this qualitative synthesis can be addressed by specific points of action to support parent‐delivered therapy interventions. We have summarized these in a checklist for use by intervention developers, health care professionals, and parents. [ABSTRACT FROM AUTHOR]

Ventricular assist devices (VADs) are playing an increasing role in the management of heart failure. VADs are mechanical circulatory devices that support or replace the function of a failing heart. Currently, VADs are only offered in theUnited Kingdom (UK) to patients waiting for a heart transplant; however, the use of these devices is likely to increase in the near future. Presently, there is a dearth of literature exploring the day-to-day realities of living with a VAD, which will become increasingly important as the role of VADs is increased. This paper adopts an interpretive phenomenological approach to uncover the experience of ‘Being’ a VAD recipient. Semi-structured interviews were conducted with 20 VAD recipients. The overarching theme is that life with a VAD is a liminal existence. This comprised four subthemes: the first examines how the VAD imposes limitations on recipients' lives that can precipitate a loss of identity; the second focuses on temporal disruptions, recipients' sense of time changes from authentic to inauthentic; the third explores how the VAD itself is liminal, it is positioned as temporary rather than as the ‘answer’ to the condition; and finally, we discuss VAD recipients' projections to the future and the possibility of an end to the experience of liminality. [ABSTRACT FROM AUTHOR]

Background: We describe the collaborative development of an evidence based, free online resource namely 'paediatric musculoskeletal matters' (pmm). This resource was developed with the aim of reaching a wide range of health professionals to increase awareness, knowledge and skills within paediatric musculoskeletal medicine, thereby facilitating early diagnosis and referral to specialist care. Methods: Engagement with stakeholder groups (primary care, paediatrics, musculoskeletal specialties and medical students) informed the essential 'core' learning outcomes to derive content of pmm. Representatives from stakeholder groups, social science and web development experts transformed the learning outcomes into a suitable framework. Target audience representatives reviewed the framework and their opinion was gathered using an online survey (n = 74) and focus groups (n = 2). Experts in paediatric musculoskeletal medicine peer reviewed the content and design. Results: User preferences informed design with mobile, tablet and web compatible versions to facilitate access, various media and formats to engage users and the content presented in module format (i.e. Clinical assessment, Investigations and management, Limping child, Joint pain by site, Swollen joint(s) and Resources). Conclusions: We propose that our collaborative and evidence-based approach has ensured that pmm is user-friendly, with readily accessible, suitable content, and will help to improve access to paediatric musculoskeletal medicine education. The content is evidence-based with the design and functionality of pmm to facilitate optimal and 'real life' access to information. pmm is targeted at medical students and the primary care environment although messages are transferable to all health care professionals involved in the care of children and young people. [ABSTRACT FROM AUTHOR]

In this article, we present findings from research conducted as part of a multi-center surgical trial. Bulbar urethral stricture, a narrowing of the middle urethra, is a common cause of urinary problems in men that can have a profound impact on their lives. Semi-structured interviews were conducted with a sample of 19 men seeking treatment for urethral stricture. The findings reveal how men tend to develop routines and tactics to adapt to their symptoms and hide them from others rather than seek help. We argue that this concealment becomes an inseparable part of how the disease is managed and is an additional hidden practical and emotional burden for these men. In addition, we suggest that the patients only sought curative treatments once practices of social concealment are no longer viable. [ABSTRACT FROM AUTHOR]

Background: Understanding implementation processes is key to ensuring that complex interventions in healthcare are taken up in practice and thus maximize intended benefits for service provision and (ultimately) care to patients. Normalization Process Theory (NPT) provides a framework for understanding how a new intervention becomes part of normal practice. This study aims to develop and validate simple generic tools derived from NPT, to be used to improve the implementation of complex healthcare interventions. Objectives: The objectives of this study are to: develop a set of NPT-based measures and formatively evaluate their use for identifying implementation problems and monitoring progress; conduct preliminary evaluation of these measures across a range of interventions and contexts, and identify factors that affect this process; explore the utility of these measures for predicting outcomes; and develop an online users' manual for the measures. Methods: A combination of qualitative (workshops, item development, user feedback, cognitive interviews) and quantitative (survey) methods will be used to develop NPT measures, and test the utility of the measures in six healthcare intervention settings. Discussion: The measures developed in the study will be available for use by those involved in planning, implementing, and evaluating complex interventions in healthcare and have the potential to enhance the chances of their implementation, leading to sustained changes in working practices. [ABSTRACT FROM AUTHOR]

In this commentary, initially I return to Schegloff’s ideas about the potential promiscuity of the analyst who works with categories. I then note how Stokoe’s article is centred on working with fragments where speakers explicitly mark themselves or another speaker as a member of a specific category. I close the commentary by arguing for, at times, the inclusion of a more modest and contingent analysis that works to explore both the moments when speakers ‘go categorical’ alongside those when such category work is less explicit. [ABSTRACT FROM PUBLISHER]

Abstract: This paper describes general practitioners’ (GPs) experiences of detecting and managing alcohol and alcohol-related problems in consultations. We undertook qualitative research in two phases in the North-East of England. Initially, qualitative interviews with 29 GPs explored their everyday work with patients with alcohol-related issues. We then undertook group interviews—two with GPs and one with a primary care team—where they discussed and challenged findings of the interviews. The GPs reported routinely discussing alcohol with patients with a range of alcohol-related problems. GPs believed that this work is important, but felt that until patients were willing to accept that their alcohol consumption was problematic they could achieve very little. They tentatively introduced alcohol as a potential problem, re-introduced the topic periodically, and then waited until the patient decided to change their behaviour. They were aware that they could identify and manage more patients. A lack of time and having to work with the multiple problems that patients brought to consultations were the main factors that stopped GPs managing more risky drinkers. Centrally, we compared the results of our study with [Thom, B., & Tellez, C. (1986). A difficult business—Detecting and managing alcohol-problems in general-practice. British Journal of Addiction, 81, 405–418] seminal study that was undertaken 20 years ago. We show how the intellectual, moral, emotional and practical difficulties that GPs currently face are quite similar to those faced by GPs from 20 years ago. As the definition of what could constitute abnormal alcohol consumption has expanded, so the range of consultations that they may have to negotiate these difficulties in has also expanded. [Copyright &y& Elsevier]

Alcohol and other substance misuse problems have historically been seen as refractory in primary care, but in the past 20 years Brief Interventions have come to be seen as an important and effective response to a range of problems around ‘risky drinking’. Proponents of brief interventions have argued that these interventions are best accomplished in the community, but that primary health care professionals resist using them. This qualitative study investigated responses to alcohol problems in a maximum variation sample of 28 primary care professionals in and around a northern English city. We found clinicians negotiating alcohol problems using interactional techniques that integrated elements of brief interventions, and which fitted these to the interactional and temporal order of clinical encounters and physician–patient relationships in primary care. Central to these accounts was the problem of finding an interactional solution that drew together notions of what was both ethically and practically possible in any given encounter. [ABSTRACT FROM AUTHOR]

Abstract: In this paper, we draw on the analytic perspectives of ethnomethodology to explore doctor–patient encounters in an experimental trial of a complex intervention: an efficacy randomised controlled trial (RCT) of decision-support tools in the UK. We show how the experimental context in which these encounters take place pervades the interactions within them. We argue that two interactional orders were at work in the encounters that we observed: (i) the ceremonial order of the consultation and (ii) the assemblage of the decision-support tool trial. We demonstrate how doctors in the trial oscillate between positions as authoritative clinician and neutralistic decision-support tool-implementer, and patients move between positions as passive recipients of clinical knowledge and as active subjects required to render their experience as calculable in terms of the demands of the decision-support tools and the broader trial they are embedded in. We demonstrate how the RCT coordinates the world of the clinical environment and the world of experimental evidence. [Copyright &y& Elsevier]

Abstract: Technological solutions to problems of knowledge and practice in health care are routinely advocated. This paper explores the ways that new systems of practice are being deployed as intermediaries in interactions between clinicians and their patients. Central to this analysis is the apparent conflict between two important ways of organizing ideas about practice in primary care. First, a shift away from the medical objectification of the patient, towards patient-centred clinical practice in which patients’heterogeneous experiences and narratives of ill-health are qualitatively engaged and enrolled in decisions about the management of illness trajectories. Second the mobilization of evidence about large populations of experimental subjects revealed through an impetus towards evidence-based medicine, in which quantitative knowledge is engaged and enrolled to guide the management of illness, and is mediated through clinical guidelines. The tension between these two ways of organizing ideas about clinical practice is a strong one, but both impulses are embodied in new ‘technological’ solutions to the management of heterogeneity in the clinical encounter. Technological solutions themselves, we argue, embody and enact these tensions, but may also be opening up a new array of practices—technogovernance—in which the heterogeneous narratives of the patient-centred encounter can be resituated and guided. [Copyright &y& Elsevier]

The article examines how improved access to care can improve outcomes of juvenile idiopathic arthritis (JIA), which is the most common chronic rheumatic disease in children. It is noted that improving the outcomes of children with JIA is an important goal in paediatric rheumatology. The authors point out that the availability of safe and effective treatments is an essential factor for improving outcome in JIA. They focus on the effect of delay and inequity of appropriate care in JIA cases.

Background: The onset of disability in bathing is particularly important for older adults as it can be rapidly followed by disability in other daily activities; this may represent a judicious time point for intervention in order to improve health, well-being and associated quality of life. An important environmental and preventative intervention is housing adaptation, but there are often lengthy waiting times for statutory provision. In this randomised controlled trial (RCT), we aim to evaluate the effectiveness and cost-effectiveness of bathing adaptations compared to no adaptations and to explore the factors associated with routine and expedited implementation of bathing adaptations. Methods: BATH-OUT-2 is a multicentre, two-arm, parallel-group RCT. Adults aged 60 and over who are referred to their local authority for an accessible level access shower will be randomised, using pairwise randomisation, 1:1, to receive either an expedited provision of an accessible shower via the local authority or a usual care control waiting list. Participants will be followed up for a maximum of 12 months and will receive up to four follow-ups in this duration. The primary outcome will be the participant's physical well-being, assessed by the Physical Component Summary score of the Short Form-36 (SF-36), 4 weeks after the intervention group receives the accessible shower. The secondary outcomes include the Mental Component Summary score of the SF-36, self-reported falls, health and social care resource use, health-related quality of life (EQ-5D-5L), social care-related quality of life (Adult Social Care Outcomes Toolkit (ASCOT)), fear of falling (Short Falls Efficacy Scale), independence in bathing (Barthel Index bathing question), independence in daily activities (Barthel Index) and perceived difficulty in bathing (0–100 scale). A mixed-methods process evaluation will comprise interviews with stakeholders and a survey of local authorities with social care responsibilities in England. Discussion: The BATH-OUT-2 trial is designed so that the findings will inform future decisions regarding the provision of bathing adaptations for older adults. This trial has the potential to highlight, and then reduce, health inequalities associated with waiting times for bathing adaptations and to influence policies for older adults. Trial registration: ISRCTN Registry ISRCTN48563324. Prospectively registered on 09/04/2021. [ABSTRACT FROM AUTHOR]

Background: The implementation science literature acknowledges a need for engagement of key stakeholders when designing, delivering and evaluating implementation work. To date, the literature reports minimal or focused stakeholder engagement, where stakeholders are engaged in either barrier identification and/or barrier prioritisation. This paper begins to answer calls from the literature for the development of tools and guidance to support comprehensive stakeholder engagement in implementation research and practice. The paper describes the systematic development of the Implementation‐STakeholder Engagement Model (I‐STEM) in the context of an international, large‐scale empirical implementation study (ImpleMentAll) aimed at evaluating the effectiveness of a tailored implementation toolkit. The I‐STEM is a sensitising tool that defines key considerations and activities for undertaking stakeholder engagement activities across an implementation process. Methods: In‐depth, semistructured interviews and observations were conducted with implementers who were tailoring implementation strategies to integrate and embed internet‐based cognitive behavioural therapy (iCBT) services in 12 routine mental health care organisations in nine countries in Europe and Australia. The analytical process was informed by principles of first‐ and third‐generation Grounded Theory, including constant comparative method. Results: We conducted 55 interviews and observed 19 implementation‐related activities (e.g., team meetings and technical support calls). The final outcome of our analysis is expressed in an initial version of the I‐STEM, consisting of five interrelated concepts: engagement objectives, stakeholder mapping, engagement approaches, engagement qualities and engagement outcomes. Engagement objectives are goals that implementers plan to achieve by working with stakeholders in the implementation process. Stakeholder mapping involves identifying a range of organisations, groups or people who may be instrumental in achieving the engagement objectives. Engagement approaches define the type of work that is undertaken with stakeholders to achieve the engagement objectives. Engagement qualities define the logistics of the engagement approach. Lastly, every engagement activity may result in a range of engagement outcomes. Conclusion: The I‐STEM represents potential avenues for substantial stakeholder engagement activity across key phases of an implementation process. It provides a conceptual model for the planning, delivery, evaluation and reporting of stakeholder engagement activities. The I‐STEM is nonprescriptive and highlights the importance of a flexible, iterative approach to stakeholder engagement. It is developmental and will require application and validation across a range of implementation activities. Patient or Public Contribution: Patient contribution to ImpleMentAll trial was facilitated by GAMIAN‐Europe at all stages—from grant development to dissemination. GAMIAN‐Europe brings together a wide variety of patient representation organisations (local, regional and national) from almost all European countries. GAMIAN‐Europe was involved in pilot testing the ItFits‐toolkit and provided their views on the various aspects, including stakeholder engagement. Patients were also represented in the external advisory board providing support and advice on the design, conduct and interpretation of the wider project, including the development of the ItFits‐toolkit. Trial registration: ClinicalTrials.gov NCT03652883. Retrospectively registered on 29 August 2018. [ABSTRACT FROM AUTHOR]

Background: In the UK just over a fifth of all children start school overweight or obese and overweight 2-5 year olds are at least 4 times more likely to become overweight adults. This can lead to serious future health problems. The WHO have recently highlighted the preschool years as a critical time for obesity prevention, and have recommended preschools as an ideal setting for intervention. However, existing evidence suggests that the preschool environment, including the knowledge, beliefs and practices of preschool staff and parents of young children attending nurseries can be a barrier to the successful implementation of healthy eating interventions in this setting.Methods: This study examined the perceptions of preschool centre staff and parents' of preschool children of healthy eating promotion within preschool settings. The participants were preschool staff working in private and local authority preschool centres in the North East of England, and parents of preschool children aged 3-4 years. Preschool staff participated in semi-structured interviews (n = 16 female, 1 male). Parents completed a mapping activity interview (n = 14 mothers, 1 father). Thematic analysis was applied to interpret the findings.Results: Complex communication issues surrounding preschool centre dietary 'rules' were apparent. The staff were keen to promote healthy eating to families and felt that parents needed 'education' and 'help'. The staff emphasised that school policies prohibited providing children with sugary or fatty snacks such as crisps, cakes, sweets and 'fizzy' drinks, however, some preschool centres appeared to have difficulty enforcing such guidelines. Parents were open to the idea of healthy eating promotion in preschool settings but were wary of being 'told what to do' and being thought of as 'bad parents'.Conclusions: There is a need to further explore nursery staff members' personal perceptions of health and how food policies which promote healthier food in preschool settings can be embedded and implemented. Family friendly healthy eating strategies and activities which utilise nudge theory should be developed and delivered in a manner that is sensitive to parents' concerns. Preschool settings may offer an opportunity for delivery of such activities. [ABSTRACT FROM AUTHOR]

Multi-disciplinary team meetings (MDT's) in paediatric rheumatology regularly meet to discuss children/young people with complex conditions, in which chronic pain may feature. Little is known about healthcare professional to healthcare professional communication and how this may influence the care of children/young people with chronic pain. The objective of the current study was to explore this knowledge gap. This study was a non-participant ethnographic observation of virtual and face-to-face MDT meetings. Three paediatric rheumatology centres participated. A structured observation checklist was used to capture field notes which were analysed using an inductive thematic approach. Ten meetings from each team (n=30) were analysed. Analysis was organised into three core inter-related elements of communication: Describing the child/young person with pain: Personality characteristics (e.g. "He is mature" or "sensitive") were frequently used in child/young person introductions. These were always accompanied by a description of parents' personality traits (e.g. "Mum can shout"). Familiarity with the child/young person and parents was important (e.g., "I haven't got a handle on them"). Interpretations were also influenced by "gut feelings" or "vibes something else was going on". Healthcare professionals discussed the need for acceptance of pain (e.g., "She wasn't buying into that explanation", "He needs to get used to it"). Setting boundaries for accessing the team also featured in discussions (e.g., "I had to set expectations for mum because it was getting too much"). Findings: suggest that healthcare professionals in paediatric rheumatology describe, interpret and manage the child/young person presenting with pain alongside the broader psychosocial (less frequently the biological) context. These Findings: will inform the Methods: and content of a new behaviour change intervention to improve pain communication amongst the paediatric rheumatology team of healthcare professionals in the UK. [ABSTRACT FROM AUTHOR]

Background: Understanding implementation processes is key to ensuring that complex interventions in healthcare are taken up in practice and thus maximize intended benefits for service provision and (ultimately) care to patients. Normalization Process Theory (NPT) provides a framework for understanding how a new intervention becomes part of normal practice. This study aims to develop and validate simple generic tools derived from NPT, to be used to improve the implementation of complex healthcare interventions.Objectives: The objectives of this study are to: develop a set of NPT-based measures and formatively evaluate their use for identifying implementation problems and monitoring progress; conduct preliminary evaluation of these measures across a range of interventions and contexts, and identify factors that affect this process; explore the utility of these measures for predicting outcomes; and develop an online users' manual for the measures.Methods: A combination of qualitative (workshops, item development, user feedback, cognitive interviews) and quantitative (survey) methods will be used to develop NPT measures, and test the utility of the measures in six healthcare intervention settings.Discussion: The measures developed in the study will be available for use by those involved in planning, implementing, and evaluating complex interventions in healthcare and have the potential to enhance the chances of their implementation, leading to sustained changes in working practices. [ABSTRACT FROM AUTHOR]

Background: Around a fifth of children starting school in England are now overweight/obese. There is a paucity of interventions with the aim of obesity prevention in preschool-age children in the UK. Previous research has demonstrated some positive results in changing specific health behaviours, however, positive trends in overall obesity rates are lacking. Preschool settings may provide valuable opportunities to access children and their families not only for promoting healthy lifestyles, but also to develop and evaluate behaviour-change interventions.Methods: This paper presents a cluster randomised feasibility study of a theory based behaviour-change preschool practitioner-led intervention tested in four preschool centres in the North East of England. The primary outcome measures were to test the acceptability and feasibility of the data collection measures and intervention. Secondary measures were collected and reported for extra information. At baseline and post intervention, children's anthropometric, dietary and physical activity measures as well as family 'active' time data were collected. The preschool practitioner-led intervention included family intervention tasks such as 'family goal-setting activities' and 'cooking challenges'. Preschool activities included increasing physical activity and providing activities with the potential to change behaviour with increased knowledge of and acceptance of healthy eating. The process evaluation was an on-going monthly process and was collected in multiple forms such as questionnaires, photographs and verbal feedback.Results: 'Gatekeeper' permission and lower-hierarchal adherence were initially a problem for recruitment and methods acceptance. However, at intervention end the preschool teachers and parents stated they found most intervention methods and activities acceptable, and some positive changes in family health behaviours were reported. However, the preschool centres appeared to have difficulties with enforcing everyday school healthy eating policies.Conclusions: The findings from the current study may have implications for nursery practitioners, nursery settings, Local Educational Authorities and policy makers, and contributes to the body of literature. However, further work with preschool practitioners is required to determine how personal attitudes and school policy application can be supported to implement successfully such an intervention.Trial Registration: ISRCTN12345678 (16/02/17) retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Open Science is 'the movement to make scientific research, data and dissemination accessible to all levels of an inquiring society'. In the spirit of the Open Science movement, advance publication of protocols for clinical trials is now being advocated by BioMed Central, BMJ Open and others. Simultaneously, participants are becoming increasingly active in their pursuit and sharing of trial- and health- related information. Whilst access to protocols alongside published trial findings has clear benefits, advance publication of trial protocols is potentially problematic for trials of complex behavioural interventions. In this article we explain, with examples, how this could lead to unblinding, 'contamination' between intervention and control groups and deliberate biasing of assessment outcomes by participants. We discuss potential solutions and demonstrate the need for public debate about how this issue is best managed.Conclusion: Triallists may still be underestimating participants' interest in information. This needs to change: joint and open discussions with the public are needed to inform how we should proceed. [ABSTRACT FROM AUTHOR]

International health and social care systems are experiencing unprecedented pressure and demand. 'Single‐handed care' initiatives seek to identify whether all or part of a homecare package involving more than one care worker can be safely reduced to a single worker. Little is known about these initiatives across local authorities. The aim of this study was to identify, describe and explain current processes and practices for single‐handed care initiatives and double‐handed homecare reviews. An electronic survey link was sent to each local authority with social care responsibilities in England. The questions covered a range of areas in relation to single‐handed care processes and included a combination of pre‐coded and free‐text responses. Responses were received from 76 (50%) local authorities. Findings were that over 12,000 reviews were reported within a year with a median of 141 (IQR 45–280) from 53 authorities that provided figures. Reviews were usually led by a local authority occupational therapist. On average, 540 min was spent per review, including conducting and organising the review, documentation, and travel. In nearly half the authorities, double handed care remained at least partially in place following at least 80% of the reviews and remained wholly in place following at least 60%. Local authorities also reported some resistance from homecare providers when implementing single‐handed care. The findings have confirmed anecdotal evidence that reviews of double‐handed homecare packages are common practice within local authorities. Given the amount of time taken with these reviews, and paucity of evidence on outcomes for people receiving them, further research should evaluate this. [ABSTRACT FROM AUTHOR]

Background: There is currently little patient information on bronchiectasis, a chronic lung disease with rising prevalence. Previous work shows that patients and their families want more information, which could potentially improve their understanding and self-management. Using interviews and focus groups, we have co-developed a novel patient and carer information resource, aiming to meet their identified needs. The aims and objectives are: 1. To assess the potential impact of the information resource 2. To evaluate and refine the intervention 3. To establish the feasibility of carrying out a multi-centre randomised controlled trial to determine its effect on understanding, self-management and health outcomesMethods/design: This is a feasibility study, with a single-centre, randomised controlled trial design, comparing use of a novel patient information resource to usual care in bronchiectasis. Additionally, patients and carers will be invited to focus groups to discuss their views on both the intervention itself and the trial process. The study duration for each participant will be 3 months from the study entry date. A total of 70 patients will be recruited to the study, and a minimum of 30 will be randomised to each arm. Ten participants (and their carers if applicable) will be invited to attend focus groups on completion of the study visits. Participants will be adults with bronchiectasis diagnosed as per national bronchiectasis guidelines. Once consented, participants will be randomised to the intervention or control arm using random permuted blocks to ensure treatment group numbers are evenly balanced. Randomisation will be web-based. Those randomised to the intervention will receive the information resource (website and booklet) and instructions on its use. Outcome measures (resource satisfaction, resource use and alternative information seeking, quality of life questionnaires, unscheduled healthcare visits, exacerbation frequency, bronchiectasis knowledge questionnaire and lung function tests) will be recorded at baseline, 2 weeks and 3 months.Discussion: All outcome measures will be used in assessing feasibility and acceptability of a future definitive trial. Feasibility outcomes include recruitment, retention and study scale form completion rates. Focus groups will strengthen qualitative data for resource refinement and to identify participant views on the trial process, which will also inform feasibility assessments. Questionnaires will also be used to evaluate and refine the resource.Trial Registration: ISRCTN84229105. [ABSTRACT FROM AUTHOR]

Background There is increasing recognition of the importance of providing quality healthcare to meet the biopsychosocial needs of young people. 'Developmentally appropriate healthcare' (DAH) for young people is one term used to explain what these services consist of. However, this term remains ill defined. Aims (i) To analyse the use of the term DAH in the scientific literature and (ii) to identify and explore the range of meanings attributed to the term in relation to young people. Methods A scoping review was conducted to map the presence of the term DAH in the literature. To analyse the use and meanings attributed to the DAH terminology, data underwent qualitative content analysis using a summative approach. Results 62 papers were selected and subjected to content analysis. An explicit definition of DAH was provided in only 1 of the 85 uses of the term DAH within the data set and in none of the 58 uses of the prefix 'developmentally appropriate'. A link between the use of the term DAH and the domains of adolescent medicine, young people, chronic conditions and transitional care was identified; as were the core ideas underpinning the use of DAH. Conclusions There is a need for consistency in the use of the term DAH for young people, the related stage-of life terminology and age range criteria. Consensus is now needed as to the content and range of a formal conceptual and operational definition. [ABSTRACT FROM AUTHOR]

Background: Normalisation Process Theory (NPT) is frequently used to inform qualitative research that aims to explain and evaluate processes that shape late-stage translation of innovations in the organisation and delivery of healthcare. A coding manual for qualitative researchers using NPT will facilitate transparent data analysis processes and will also reduce the cognitive and practical burden on researchers.Objectives: (a) To simplify the theory for the user. (b) To describe the purposes, methods of development, and potential application of a coding manual that translates normalisation process theory (NPT) into an easily usable framework for qualitative analysis. (c) To present an NPT coding manual that is ready for use.Method: Qualitative content analysis of papers and chapters that developed normalisation process theory, selection and structuring of theory constructs, and testing constructs against interview data and published empirical studies using NPT.Results: A coding manual for NPT was developed. It consists of 12 primary NPT constructs and conforms to the Context-Mechanism-Outcome configuration of realist evaluation studies. Contexts are defined as settings in which implementation work is done, in which strategic intentions, adaptive execution, negotiating capability, and reframing organisational logics are enacted. Mechanisms are defined as the work that people do when they participate in implementation processes and include coherence-building, cognitive participation, collective action, and reflexive monitoring. Outcomes are defined as effects that make visible how things change as implementation processes proceed and include intervention mobilisation, normative restructuring, relational restructuring, and sustainment.Conclusion: The coding manual is ready to use and performs three important tasks. It consolidates several iterations of theory development, makes the application of NPT simpler for the user, and links NPT constructs to realist evaluation methods. The coding manual forms the core of a translational framework for implementation research and evaluation. [ABSTRACT FROM AUTHOR]

With the most recent developments to the European General Data Protection Regulations (GDPR) introduced in May 2018, the resulting legislation meant a new set of considerations for study approvers and health‐care researchers. Compared with previous legislation in the UK (The Data Protection Act, 1998), it introduced more extensive and directive principles, requiring anybody 'processing' personal data to specifically define how this data will be obtained, stored, used and destroyed. Importantly, it also emphasised the principle of accountability, which meant that data controllers and processors could no longer just state that they planned to adhere to lawful data protection principles, they also had to demonstrate compliance. New questions and concerns around accountability now appear to have increased levels of scrutiny in all areas of information governance (IG), especially with regards to processing confidential patient information. This article explores our experiences of gaining required ethical and regulatory approvals for an ethnographic study in a UK health‐care setting, the implications that the common law duty of confidentiality had for this research, and the ways in which IG challenges were overcome. The purpose of this article was to equip researchers embarking on similar projects to be able to navigate the potentially problematic and complex journey to approval. [ABSTRACT FROM AUTHOR]

Background: Much of the research on decision-making in health care has focused on consultation outcomes. Less is known about the process by which clinicians and patients come to a treatment decision. This study aimed to quantitatively describe the behaviour shown by doctors and patients during primary care consultations when three types of decision aids were used to promote treatment decision-making in a randomised controlled trial. Methods: A video-based study set in an efficacy trial which compared the use of paper-based guidelines (control) with two forms of computer-based decision aids (implicit and explicit versions of DARTS II). Treatment decision concerned warfarin anti-coagulation to reduce the risk of stroke in older patients with atrial fibrillation. Twenty nine consultations were video-recorded. A ten-minute 'slice' of the consultation was sampled for detailed content analysis using existing interaction analysis protocols for verbal behaviour and ethological techniques for nonverbal behaviour. Results: Median consultation times (quartiles) differed significantly depending on the technology used. Paperbased guidelines took 21 (19-26) minutes to work through compared to 31 (16-41) minutes for the implicit tool; and 44 (39-55) minutes for the explicit tool. In the ten minutes immediately preceding the decision point, GPs dominated the conversation, accounting for 64% (58-66%) of all utterances and this trend was similar across all three arms of the trial. Information-giving was the most frequent activity for both GPs and patients, although GPs did this at twice the rate compared to patients and at higher rates in consultations involving computerised decision aids. GPs' language was highly technically focused and just 7% of their conversation was socio-emotional in content; this was half the socio-emotional content shown by patients (15%). However, frequent head nodding and a close mirroring in the direction of eye-gaze suggested that both parties were active participants in the conversation Conclusion: Irrespective of the arm of the trial, both patients' and GPs' behaviour showed that they were reciprocally engaged in these consultations. However, even in consultations aimed at promoting shared decisionmaking, GPs' were verbally dominant, and they worked primarily as information providers for patients. In addition, computer-based decision aids significantly prolonged the consultations, particularly the later phases. These data suggest that decision aids may not lead to more 'sharing' in treatment decision-making and that, in their current form, they may take too long to negotiate for use in routine primary care. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To explore participants’ understandings regarding treatment decisions, made within an efficacy randomised controlled trial (RCT) of decision-support tools. Methods: Qualitative study: interviews (audio-recorded) with participants. Participants were interviewed 3–5 days after using a decision-support tool (n =30) and again at 3 months (n =26). Transcripts were analysed using a constant comparative approach. Results: Participants’ understandings were shaped by the ways in which they made sense of their participation. Participants made attributions about their trial identity that fell on a continuum. At one end we found participants who identified as ‘experienced medical volunteers’, and at the other those who identified as ‘real patients’. In the participants’ accounts, a trial identity of ‘patient’ accompanied an expectation that the decision-support tools offered a means of making treatment decisions. ‘Volunteers’, however, saw the interventions as tasks to be completed for the purposes of the trial team. Conclusion: In our study, trial identity shaped participants’ understandings regarding treatment decisions and all other aspects of the trial. Practice implications: Different understandings regarding the appropriate response to trial tasks may affect behaviour and therefore outcomes in some trials. Further research is required to unravel the relationship between trial identities, understanding and behaviour. [Copyright &y& Elsevier]

Background: Multimorbidity is common in older adults and associated with high levels of illness burden and healthcare expenditure. The evidence base for how to manage older adults with multimorbidity is weak. Yoga might be a useful intervention because it has the potential to improve health-related quality of life, physical functioning, and several medical conditions. The British Wheel of Yoga's Gentle Years Yoga© (GYY) programme was developed specifically for older adults, including those with chronic medical conditions. Data from a pilot trial suggested feasibility of using GYY in this population, but its effectiveness and cost-effectiveness remain uncertain.Methods: This is a multi-site, individually randomised, superiority trial with an embedded process evaluation and an economic analysis of cost-effectiveness. The trial will compare an experimental strategy of offering a 12-week GYY programme against a control strategy of no offer in community-dwelling adults aged 65 or over who have multimorbidity, defined as having two or more chronic conditions from a predefined list. The primary outcome is health-related quality of life measured using the EQ-5D-5L, the primary endpoint being the overall difference over 12 months. Both groups will continue to be able to access their usual care from primary, secondary, community, and social services. Participants, care providers, and yoga teachers will not be blinded to the allocated intervention. Outcome measures are primarily self-reported. The analysis will follow intention-to-treat principles.Discussion: This pragmatic randomised controlled trial will demonstrate if the GYY programme is an effective, cost-effective, and viable addition to the management of older adults with multimorbidity.Trial Registration: ISRCTN ISRCTN13567538 . Registered on 18 March 2019. [ABSTRACT FROM AUTHOR]

Context: Pre‐appointment written materials, including letters and leaflets, are commonly used by healthcare organisations to deliver professional‐patient interactions. The written materials potentially change patients' knowledge and behaviour as part of a healthcare intervention but have received little investigation. Objective: To describe the content of pre‐appointment written materials through a behaviour change intervention perspective. Design: Mixed methods study with an online questionnaire about pre‐appointment written materials and an analysis of actual materials. Questionnaire data were analysed descriptively and pre‐appointment materials by qualitative framework analysis. Setting and participants: Children's community/outpatient occupational therapy, physiotherapy and/or speech and language therapy services across the UK. Service managers/clinical leads provided data. Intervention: Pre‐appointment written materials. Results: Questionnaire responses were received from n = 110 managers/clinical leads from n = 58 NHS organisations. Written materials (n = 64) were received from n = 24 organisations. Current materials are used by therapy services as a conduit to convey the therapy service's expectations related to: accessing the service, decision‐making about care and help‐giving. The materials enrol the parent and child to the therapy services' expectations by behaviour change techniques. The materials configure the parent/child expectations, knowledge and behaviour towards the therapy services' operational procedures. Conclusion: Pre‐appointment written materials configure patients to organisations' operational procedures. The written materials currently lack support for parent/child empowerment, shared decision‐making and self‐management to improve health. Patient Contribution: Four parents of children accessing therapy services were involved in the study. The parents shared their experiences to highlight the importance of the topic and contributed to the final research design and methods. [ABSTRACT FROM AUTHOR]

Urethral stricture affects 0.9% of men. Initial treatment is urethrotomy. Approximately, half of the strictures recur within 4 yr. Options for further treatment are repeat urethrotomy or open urethroplasty. To compare the effectiveness and cost-effectiveness of urethrotomy with open urethroplasty in adult men with recurrent bulbar urethral stricture. This was an open label, two-arm, patient-randomised controlled trial. UK National Health Service hospitals were recruited and 222 men were randomised to receive urethroplasty or urethrotomy. Urethrotomy is a minimally invasive technique whereby the narrowed area is progressively widened by cutting the scar tissue with a steel blade mounted on a urethroscope. Urethroplasty is a more invasive surgery to reconstruct the narrowed area. The primary outcome was the profile over 24 mo of a patient-reported outcome measure, the voiding symptom score. The main clinical outcome was time until reintervention. The primary analysis included 69 (63%) and 90 (81%) of those allocated to urethroplasty and urethrotomy, respectively. The mean difference between the urethroplasty and urethrotomy groups was –0.36 (95% confidence interval [CI] –1.74 to 1.02). Fifteen men allocated to urethroplasty needed a reintervention compared with 29 allocated to urethrotomy (hazard ratio [95% CI] 0.52 [0.31–0.89]). In men with recurrent bulbar urethral stricture, both urethroplasty and urethrotomy improved voiding symptoms. The benefit lasted longer for urethroplasty. There was uncertainty about the best treatment for men with recurrent bulbar urethral stricture. We randomised men to receive one of the following two treatment options: urethrotomy and urethroplasty. At the end of the study, both treatments resulted in similar and better symptom scores. However, the urethroplasty group had fewer reinterventions. There was no evidence of a difference regarding voiding symptoms in men with recurrent bulbar urethral stricture randomised to urethrotomy or urethroplasty. However, men allocated to urethroplasty had fewer reinterventions than those allocated to urethrotomy. [ABSTRACT FROM AUTHOR]

The article presents the authors' comment on the novel medical terminologies. According to the authors, the introduction of new terms has enhanced physicians' ability to understand and engage with patients and the medications. It has also brought a fundamental change in the doctor-patient relationship. The terms fulfil the requirement of a realistic and pragmatic approach in which a patient must be taken willingly along a path of treatment.

Background: There has been comparatively little patient information about bronchiectasis, a chronic lung disease with rising prevalence. Patients want more information, which could improve their understanding and self-management. A novel information resource meeting identified needs has been co-developed in prior work. We sought to establish the feasibility of conducting a multi-centre randomised controlled trial to determine effect of the information resource on understanding, self-management and health outcomes.Methods/design: We conducted an unblinded, single-centre, randomised controlled feasibility trial with two parallel groups (1:1 ratio), comparing a novel patient information resource with usual care in adults with bronchiectasis. Integrated qualitative methods allowed further evaluation of the intervention and trial process. The setting was two teaching hospitals in North East England. Participants randomised to the intervention group received the information resource (website and booklet) and instructions on its use. Feasibility outcome measures included willingness to enter the trial, in addition to recruitment and retention rates. Secondary outcome measures (resource use and satisfaction, quality of life, unscheduled healthcare presentations, exacerbation frequency, bronchiectasis knowledge and lung function) were recorded at baseline, 2 weeks and 12 weeks.Results: Sixty-two participants were randomised (control group = 30; intervention group = 32). Thirty-eight (61%) were female, and the participants' median age was 65 years (range 15-81). Median forced expiratory volume in 1 s percent predicted was 68% (range 10-120). Sixty-two of 124 (50%; 95% CI, 41-59%) of potentially eligible participants approached were recruited. Sixty (97%) of 62 participants completed the study (control group, 29 of 30 [97%]; 95% CI, 83-99%; 1 unrelated death; intervention group, 31 [97%] of 32; 95% CI, 84-99%; 1 withdrawal). In the intervention group, 27 (84%) of 32 reported using the information provided, and 25 (93%) of 27 of users found it useful, particularly the video content. Qualitative data analysis revealed acceptability of the trial and intervention. Web analytics recorded over 20,000 page views during the 16-month study period.Conclusion: The successful recruitment process, high retention rate and study form completion rates indicate that it appears feasible to conduct a full trial based on this study design. Worldwide demand for online access to the information resource was high.Trial Registration: ISRCTN Registry, ISRCTN84229105. Registered on 25 July 2014. [ABSTRACT FROM AUTHOR]

Background: Effective implementation of healthcare initiatives is of key importance for ensuring high‐quality clinical and health outcomes. Using Normalization Process Theory, this study investigates the implementation behaviour of dental students in relation to a novel oral health risk assessment tool. It considers the impact of advancing learning on normalisation of innovative healthcare practice. Methods: Students completed the NoMAD (normalisation of complex interventions‐measure development) questionnaire and an additional scale to assess perceived value of the oral health risk assessment tool, after having used the tool for nearly one academic year. The sample comprised third‐ (n = 75), fourth‐ (n = 77) and fifth‐year (n = 37) students. Differences between groups in relation to the four generative processes of normalisation were analysed using ANOVA. Cohen's d effect sizes were calculated between groups. Multiple linear regression was undertaken to investigate the impact of normalisation level on value/utility judgements. Results: There were significant group differences for three of the four generative processes of normalisation (coherence, cognitive participation and reflexive monitoring). Third‐ and fourth‐year students were highly similar but these groups showed lower normalisation compared to fifth years. Normalisation assessment predicted perceived value and utility of the oral health risk assessment tool. Conclusions: The findings suggest that dental students show lower normalisation of novel tools at earlier stages in their course, possibly due to increased cognitive load, and that perceived value and utility of a novel tool is related to increased normalisation. [ABSTRACT FROM AUTHOR]

Background: People with long term conditions (LTCs) make most of the daily decisions and carry out the activities which affect their health and quality of life. Only a fraction of each contact with a health care professional (HCP) is spent supporting this. This paper describes how care and support planning (CSP) and an implementation framework to redesign services, were developed to address this in UK general practice. Focussed on what is important to each individual, CSP brings together traditional clinical issues and the person's lived experience in a solution focussed, forward looking conversation with an emphasis on 'people not diseases'. Methods: The components of CSP were developed in three health communities using diabetes as an exemplar. This model was extended and refined for other single conditions and multimorbidity across 40 sites and two nations, over 15 years. Working with local teams and communities the authors used theoretical models of care, implementation and spread, developing and tailoring training, support and resources to embed CSP as usual care, sharing learning across a community of practice. Results: The purpose, content, process, developmental hurdles and impact of this CSP model are described, alongside an implementation strategy. There is now a robust, reproducible five step model; preparation, conversation, recording, actions and review. Uniquely, preparation, involving information sharing with time for reflection, enables an uncluttered conversation with a professional focussed on what is important to each person. The components of the Year of Care House act as a checklist for implementation, a metaphor for their interdependence and a flexible framework. Spreading CSP involved developing exemplar practices and building capacity across local health communities. These reported improved patient experience, practitioner job satisfaction, health behaviours and outcomes, teamwork, practice organisation, resource use, and links with wider community activities. Conclusions: Tested in multiple settings, CSP is a reproducible and practical model of planned care applicable to all LTCs, with the capacity to be transformative for people with LTCs and health care professionals. It recaptures relational dimensions of care with transactional elements in the background. Options for applying this model and implementation framework at scale now need to be explored. [ABSTRACT FROM AUTHOR]

Introduction: Successful implementation and embedding of new health care practices relies on co-ordinated, collective behaviour of individuals working within the constraints of health care settings. Normalization Process Theory (NPT) provides a theory of implementation that emphasises collective action in explaining, and shaping, the embedding of new practices. To extend the practical utility of NPT for improving implementation success, an instrument (NoMAD) was developed and validated.Methods: Descriptive analysis and psychometric testing of an instrument developed by the authors, through an iterative process that included item generation, consensus methods, item appraisal, and cognitive testing. A 46 item questionnaire was tested in 6 sites implementing health related interventions, using paper and online completion. Participants were staff directly involved in working with the interventions. Descriptive analysis and consensus methods were used to remove redundancy, reducing the final tool to 23 items. Data were subject to confirmatory factor analysis which sought to confirm the theoretical structure within the sample.Results: We obtained 831 completed questionnaires, an average response rate of 39% (range: 22-77%). Full completion of items was 50% (n = 413). The confirmatory factor analysis showed the model achieved acceptable fit (CFI = 0.95, TLI = 0.93, RMSEA = 0.08, SRMR = 0.03). Construct validity of the four theoretical constructs of NPT was supported, and internal consistency (Cronbach's alpha) were as follows: Coherence (4 items, α = 0.71); Collective Action (7 items, α = 0.78); Cognitive Participation (4 items, α = 0.81); Reflexive Monitoring (5 items, α = 0.65). The normalisation scale overall, was highly reliable (20 items, α = 0.89).Conclusions: The NoMAD instrument has good face validity, construct validity and internal consistency, for assessing staff perceptions of factors relevant to embedding interventions that change their work practices. Uses in evaluating and guiding implementation are proposed. [ABSTRACT FROM AUTHOR]

Abstract: Background: Primary hypothyroidism is a common endocrine disorder, more so in an increasing UK ageing population. There is no qualitative research examining the older patient perspective of symptoms, treatment and self‐management of hypothyroidism. Objective: In this study we explored the experience of hypothyroidism in older people and examined how this may influence their understanding and acceptance of diagnosis, treatment with Levothyroxine and the monitoring process. Design: We conducted semi‐structured interviews with 18 participants aged between 80 and 93 years. Interview transcripts were analysed using a thematic approach. Results: The themes involved older individuals’ knowledge about symptoms, confidence in diagnosis and understanding of clinical management regimen to understand hypothyroidism. Interpretation of the themes was informed by the Health Belief Model. Conclusion: Our findings can help to inform the development of interventions by treating clinicians and support staff to engage older patients in the long‐term management of this chronic condition. [ABSTRACT FROM AUTHOR]

Background: Ventricular assist devices (VADs) are a relatively new development in the management of advanced heart failure. In the UK, VAD recipients comprise a unique group of less than 200 patients. This is the first paper to explore the experience of VAD communities, the extent to which communities are developed around the device, and how these influence the experience of living with the VAD. Methods: Qualitative interviews were conducted with 20 VAD recipients (implanted as a bridge to transplantation), 11 interviews also included the VAD recipients’ partners. Interpretive phenomenology was employed as the theoretical basis guiding the analysis of the interviews. Results: Four key themes emerged from the data: the existence of VAD communities; experiential knowledge and understanding; social comparisons; and the impacts of deaths within the VAD community. Many of the interviewees valued the VAD communities and the relationships they had formed with fellow recipients. The beneficial impacts of the VAD communities included offering recently implanted patients a realistic view of what to expect from life with a VAD; this could aid them in accepting and adapting to the changes imparted by the device. However, negative impacts of the VAD communities were also reported, in particular following deaths within the group, which were a source of distress for many of the interviewees. Conclusions: In general, the VAD communities appeared to be a beneficial source of support for the majority of interviewees. Consideration should be given to how these communities could be supported by clinicians. [ABSTRACT FROM AUTHOR]

Background Newspaper stories can impact behaviours, particularly in relation to research participation. It is therefore important to understand the narratives presented and ways in which these are received. Some work to date assumes journalism transmits existing medical knowledge to a passive audience. This study aimed to explore how newspaper articles present stories about medical research and how people interpret and use them. Design Qualitative research methods were employed to analyse two data sets: newspaper articles relating to 'rheumatoid arthritis' and 'research' from UK local and national news sources; and existing transcripts of interviews with patients with rheumatoid arthritis and their carers. Results Newspapers present a positive account of medical research, through a simple narrative with three essential components: an 'innovation' offers 'hope' in the context of 'burden'. Patients frequently feature as passive subjects without attributed opinions. Few articles include patients' experiences of research involvement. Patients with rheumatoid arthritis and their carers read articles about medical research critically, often with cynicism and drawing on other sources for interpretation. Conclusions An understanding of the simple, positive narrative of medical research found in newspaper articles may enable researchers to gain mass media exposure for their work and challenge this typical style of reporting. The critical and cynical ways patients and carers read stories about medical research suggest that concerns about newspaper articles misinforming the public may be overstated, but any effect on research engagement is unknown. Newspaper articles rarely present patients' views or their experiences of research, and this can be conceptualized as 'depersonalization bias'. [ABSTRACT FROM AUTHOR]

Objectives. To identify whether sleep disturbances are more prevalent in primary SS (pSS) patients compared with the general population and to recognize which specific sleep symptoms are particularly problematic in this population. Methods. Electronic searches of the literature were conducted in PubMed, Medline (Ovid), Embase (Ovid), PsychINFO (Ovid) and Web of Science and the search strategy registered a priori. Titles and abstracts were reviewed by two authors independently against a set of prespecified inclusion/exclusion criteria, reference lists were examined and a narrative synthesis of the included articles was conducted. Results. Eight whole-text papers containing nine separate studies met the inclusion criteria and were included in the narrative analysis. Few of these studies met all of the quality assessment criteria. The studies used a range of self-reported measures and objective measures, including polysomnography. Mixed evidence was obtained for some of the individual sleep outcomes, but overall compared with controls, pSS patients reported greater subjective sleep disturbances and daytime somnolence and demonstrated more night awakenings and pre-existing obstructive sleep apnoea. Conclusions. A range of sleep disturbances are commonly reported in pSS patients. Further polysomnography studies are recommended to confirm the increased prevalence of night awakenings and obstructive sleep apnoea in this patient group. pSS patients with excessive daytime somnolence should be screened for co-morbid sleep disorders and treated appropriately. Interventions targeted at sleep difficulties in pSS, such as cognitive behavioural therapy for insomnia and nocturnal humidification devices, have the potential to improve quality of life in this patient group and warrant further investigation. [ABSTRACT FROM AUTHOR]

Background: This paper proposes a novel perspective on the value of qualitative research for improving trial design and optimising recruitment. We report findings from a qualitative study set within the OPEN trial, a surgical randomised controlled trial (RCT) comparing two interventions for recurrent bulbar urethral stricture, a common cause of urinary problems in men.Methods: Interviews were conducted with men meeting trial eligibility criteria (n = 19) to explore reasons for accepting or declining participation and with operating urologists (n = 15) to explore trial acceptability.Results: Patients expressed various preferences and understood these in the context of relative severity and tolerability of their symptoms. Accounts suggest a common trajectory of worsening symptoms with a particular window within which either treatment arm would be considered acceptable. Interviews with clinician recruiters found that uncertainty varied between general and specialist sites, which reflect clinicians' relative exposure to different proportions of the patient population.Conclusion: Recruitment post referral, at specialist sites, was challenging due to patient (and clinician) expectations. Trial design, particularly where there are fixed points for recruitment along the care pathway, can enable or constrain the possibilities for effective accrual depending on how it aligns with the optimum point of patient equipoise. Qualitative recruitment investigations, often focussed on information provision and patient engagement, may also look to better understand the target patient population in order to optimise the point at which patients are approached.Trial Registration: ISRCTN Registry, ISRCTN98009168 . Registered on 29 November 2012. [ABSTRACT FROM AUTHOR]