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Background Normalization Process Theory (NPT) identifies, characterises and explains key mechanisms that promote and inhibit the implementation, embedding and integration of new health techniques, technologies and other complex interventions. A large body of literature that employs NPT to inform feasibility studies and process evaluations of complex healthcare interventions has now emerged. The aims of this review were to review this literature; to identify and characterise the uses and limits of NPT in research on the implementation and integration of healthcare interventions; and to explore NPT’s contribution to understanding the dynamics of these processes. Methods A qualitative systematic review was conducted. We searched Web of Science, Scopus and Google Scholar for articles with empirical data in peer-reviewed journals that cited either key papers presenting and developing NPT, or the NPT Online Toolkit ( www.normalizationprocess.org ). We included in the review only articles that used NPT as the primary approach to collection, analysis or reporting of data in studies of the implementation of healthcare techniques, technologies or other interventions. A structured data extraction instrument was used, and data were analysed qualitatively. Results Searches revealed 3322 citations. We show that after eliminating 2337 duplicates and broken or junk URLs, 985 were screened as titles and abstracts. Of these, 101 were excluded because they did not fit the inclusion criteria for the review. This left 884 articles for full-text screening. Of these, 754 did not fit the inclusion criteria for the review. This left 130 papers presenting results from 108 identifiable studies to be included in the review. NPT appears to provide researchers and practitioners with a conceptual vocabulary for rigorous studies of implementation processes. It identifies, characterises and explains empirically identifiable mechanisms that motivate and shape implementation processes. Taken together, these mean that analyses using NPT can effectively assist in the explanation of the success or failure of specific implementation projects. Ten percent of papers included critiques of some aspect of NPT, with those that did mainly focusing on its terminology. However, two studies critiqued NPT emphasis on agency, and one study critiqued NPT for its normative focus. Conclusions This review demonstrates that researchers found NPT useful and applied it across a wide range of interventions. It has been effectively used to aid intervention development and implementation planning as well as evaluating and understanding implementation processes themselves. In particular, NPT appears to have offered a valuable set of conceptual tools to aid understanding of implementation as a dynamic process.

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.

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. 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. 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). 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.

Background Cerebral Palsy (CP) is an umbrella term for a group of permanent postural and movement conditions caused by non-progressive damage to the developing brain. Infants not identified with risk factors for CP around the time of birth are usually referred on from primary care after six months of age, essentially precluding early therapy. Candidacy, a seven-step dynamic theory, describes how individuals negotiate their eligibility for medical attention with themselves, others, and health services. This study aims to explore the CP diagnostic journey for community identified infants using the concept of candidacy. Methods Data was combined from two studies: an online survey of caregivers of children with CP about their earliest concerns and diagnosis journeys ( n= 255), and a series of interviews to support the development of a new tool to facilitate earlier identification of infants with emerging motor difficulties (11 parents, 11 health care professionals [HCPs]). A deductive thematic analysis was used with a semantic, critical realist approach. An initial analysis was framed by the Andersen Model of Total Patient delay, and then conceptualised using Candidacy. Results Participants had difficulties identifying whether their child needed medical attention, prompting online searches, and seeking advice from family and friends. HCP adjudications led to immediate or delayed referral, in which families continued their searches, reappearing at services until a referral was made. Once referred, families faced poor operating conditions, such as long waiting times. After learning the diagnosis criteria, participants began making requests for referral and navigated to private services if requests were denied. Participants felt that more information on infant development from a reliable source was needed to support new parents in raising their concerns to aid earlier identification. Conclusion Participants identified personal lack of infant development knowledge as being the limiting factor to earlier referral. Further research is needed to develop materials relevant for the UK and to understand General Practitioner perspectives regarding provision of such materials.

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. 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. 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. 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 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. ClinicalTrials.gov NCT03652883. Retrospectively registered on 29 August 2018.

Background The past decade has seen considerable interest in the development and evaluation of complex interventions to improve health. Such interventions can only have a significant impact on health and health care if they are shown to be effective when tested, are capable of being widely implemented and can be normalised into routine practice. To date, there is still a problematic gap between research and implementation. The Normalisation Process Theory (NPT) addresses the factors needed for successful implementation and integration of interventions into routine work (normalisation). Discussion In this paper, we suggest that the NPT can act as a sensitising tool, enabling researchers to think through issues of implementation while designing a complex intervention and its evaluation. The need to ensure trial procedures that are feasible and compatible with clinical practice is not limited to trials of complex interventions, and NPT may improve trial design by highlighting potential problems with recruitment or data collection, as well as ensuring the intervention has good implementation potential. Summary The NPT is a new theory which offers trialists a consistent framework that can be used to describe, assess and enhance implementation potential. We encourage trialists to consider using it in their next trial.

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.

Aim To understand Lead Tissue Viability Nurses' agency, autonomy and authority to perform their role. Background Lead Tissue Viability Nurses need both clinical autonomy and organisational authority to improve wound care, patient safety, and cost‐effectiveness. Their role goes beyond bedside care to include strategic decisions shaping policy, resources, and quality initiatives. Despite this, the role is often misunderstood and under‐recognised. This study, based on the four pillars of advanced nursing practice—clinical practice, education, research, and leadership—examines the challenges they face. Design A qualitative study. Methods Interviews with six Lead Tissue Viability Nurses working in large tertiary care organisations. A thematic analysis was undertaken. Results The results aligned with the four pillars of advanced nursing practice. Six sub‐themes emerged, reflecting the skills, knowledge, and influences involved, and critically, the challenges faced in meeting role expectations: Clinical Practice—working with clinical specialties (a); Education—supporting generalist nurses (b); Leadership—collaborating with dressing companies (c) and national bodies (d); Research—partnering with clinicians (e) to implement national guidance (f). Conclusion Our study highlights the restricted agency that constrains their capacity to meet the complex demands of the role. Their specialised knowledge frequently remains unacknowledged and underutilised, while their contributions are often marginalised within organisational discourse. To attain the level of recognition commensurate with this senior nursing position, their distinct professional and organisational identity should be clearly articulated. Implications for the Profession and/or Patient Care Lead Tissue Viability Nurses should be acknowledged for their advanced practice role, reflecting the specialist expertise and leadership they bring to patient care. Additionally, they must be granted the agency, autonomy and authority necessary to implement best practice. Impact Ensuring that Lead Tissue Viability Nurses can execute their duties effectively and achieve high‐quality outcomes will directly influence patient care. Patient or Public Contribution No patient or public contribution at this stage, as this study was about exploring the nurses' organisational role from their perspective.

Background Social prescribing link workers support individuals to engage with community resources, co-creating achievable goals. Most schemes are community-based, targetting adults. Vulnerable populations including hospitalized children with neurodisability and their families, could also benefit from social prescribing. Aims To pilot a hospital-initiated social prescribing service for children with neurodisability and their families; to explore its feasibility, acceptability and undertake social return on investment (SROI) analysis. Methods Mixed-methods cohort study with SROI analysis. We recruited children aged < 16y with neurodisability, identified during inpatient stays, their parents/carers and siblings. Participants received link worker support for 6 months, extending beyond hospital discharge. Pre- and post-intervention pilot data covered profile of needs (Support Star), quality of life (EQ5D/CHU-9D), wellbeing (WEMWBS/CORS) and financial strain. We undertook 22 qualitative observations of family/link worker interactions and 39 in-depth interviews with families, link workers and healthcare professionals. Together these data were analysed within a SROI to establish the costs and social value generated. Results Of 48 families supported by the service, 25 were recruited to the evaluation (26 children, aged 10 m-15y; 4 siblings; 36 parents). Baseline quality of life and wellbeing indices averaged below population norms. Link workers were highly effective at supporting families (only 6/151 goals unmet). Unmet need decreased by 6 months (Support Star, p  < 0.001). Families reported having felt overwhelmed when trying to adjust to new ways of life post diagnosis/discharge before link worker intervention, with little support to navigate non-medical needs. Parents, link workers and health care professionals found link worker support invaluable for making community services accessible. Families then felt more connected to their communities, and less isolated, with increased belief in their self-efficacy. Families and healthcare professionals felt that the duration of support, and eligibility criteria, should be extended. Inputs to deliver the service for 1 year (49 families) were estimated at £74,736: outcomes for the 18 families studied were estimated at a value of £205,861. Conclusion Hospital in-reach social prescribing is feasible, acceptable, and addresses a range of otherwise unmet needs of children with neurodisability and their families, showing a positive SROI. Other vulnerable patient groups could also benefit from this approach. Trial registration ISRCTN23306751 (2.8.22).

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.