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Background and aims Self-management support is important in persons adaptation to a new life after stroke. Significant others often provide a meaningful part of that support. The impact on family members caring for a person after stroke has been extensively studied, however there is a lack of research into significant others’ understanding and experiences of self-management after stroke. Therefore, this study aimed to explore how significant others understand self-management and how they perceive their role in supporting self-management in post-stroke rehabilitation at home. Method Qualitative, semi-structured interviews were conducted with 28 significant others of persons in rehabilitation after stroke. Data were analysed using inductive content analysis. Results The preliminary results showed that significant others commonly relate self- management to activities of daily living (ADL) and rehabilitation training. Participants saw their role as important not only to assist the stroke survivor practically, but also to provide emotional support and companionship. Conclusion There is an emerging discrepancy between descriptions in the literature and significant others’ perceptions of and actions to support self-management. If significant others obtained a clearer understanding of the concept of self- management, their support could be more efficient in strengthening self-efficacy and self-management abilities in stroke survivors. How will this research improve life after stroke for stroke survivors? By highlighting the characteristics of significant others’ self-management support and their understanding of the concept, interventions to enhance self-managementsupport for stroke survivors can be improved in the future.

Objective: Self-management support can improve quality of life, mood, self-efficacy, and physical function following a stroke. Knowledge of how people with stroke understand and experience self-management in different contexts is crucial to developing effective self-management support. This study explored how people with stroke understand and practice self-management during the post-acute phase. Method: A descriptive study using qualitative content analysis to explore data from semistructured interviews. Results: Eighteen participants were interviewed. Most participants interpreted self-management as 'taking care of their business' and 'being independent". However, they encountered difficulties performing daily activities, for which they felt unprepared. Although interest in implementing self-management support increases, participants did not report receiving specific advice from healthcare professionals. Conclusion: People continue to feel unprepared to manage everyday activities after hospital discharge and must largely work things out for themselves. There is an overlooked opportunity to start the process of selfmanagement support earlier in the stroke pathway, with healthcare professionals and people with stroke combining their skills, ideas and expertise. This would enable confidence to self-management to flourish rather than decrease during the transition from hospital to home. Practical implications: Individual tailored self-management support could help people with stroke more successfully manage their daily lives post-stroke.

Background: The implementation of complex interventions is considered challenging, particularly in multi-site clinical trials and dynamic clinical settings. This study protocol is part of the family intensive care units (FICUS) hybrid effectiveness-implementation study. It aims to understand the integration of a multicomponent family support intervention in the real-world context of adult intensive care units (ICUs). Specifically, the study will assess implementation processes and outcomes of the study intervention, including fidelity, and will enable explanation of the clinical effectiveness outcomes of the trial. - Methods and analysis: This mixed-methods multiple case study is guided by two implementation theories, the Normalisation Process Theory and the Consolidated Framework for Implementation Research. Participants are key clinical partners and healthcare professionals of eight ICUs allocated to the intervention group of the FICUS trial in the German-speaking part of Switzerland. Data will be collected at four timepoints over the 18-month active implementation and delivery phase using qualitative (small group interviews, observation, focus group interviews) and quantitative data collection methods (surveys, logs). Descriptive statistics and parametric and non-parametric tests will be used according to data distribution to analyse within and between cluster differences, similarities and factors associated with fidelity and the level of integration over time. Qualitative data will be analysed using a pragmatic rapid analysis approach and content analysis. - Ethics and dissemination: Ethics approval was obtained from the Cantonal Ethics Committee of Zurich BASEC ID 2021-02300 (8 February 2022). Study findings will provide insights into implementation and its contribution to intervention outcomes, enabling understanding of the usefulness of applied implementation strategies and highlighting main barriers that need to be addressed for scaling the intervention to

BACKGROUND: Self-management programs are recognized as a valuable approach to supporting people with long-term conditions, such as stroke, in managing their daily lives. Bridges Self-Management (Bridges) focuses on how practitioners interact and support patients' confidence, skills, and knowledge, and it is an example of a complex intervention. Bridges has been developed and used across multiple health care pathways in the United Kingdom and is theoretically informed by social cognition theory and self-efficacy principles. Evidence shows that self-management programs based on the construct of self-efficacy can be effective. There is still much to learn about how health care services or pathways should implement support for self-management in a sustainable way and whether this implementation process is different depending on the context or culture of the team or service provided. OBJECTIVE: The aim of this study is to tailor and evaluate an intervention (Bridges) to support self-management after stroke in a Swedish context. METHODS: We will use a pretest-posttest design with a case study approach to evaluate the feasibility and implementation of self-management support in two stroke settings. This project includes a complex intervention and depends on the actions of individuals, different contexts, and the adaptation of behavior over time. A mixed methods approach was chosen to understand both outcomes and mechanisms of impact. Data collection will comprise outcome measurements and assessment tools as well as qualitative interviews. Data will be collected concurrently and integrated into a mixed methods design. RESULTS: Recruitment and data collection for the first site of the project ran from September 1, 2021, to January 17, 2022. The intervention at the first site was conducted from November 1, 2021, to March 5, 2022. The evaluation will start after the implementation phase. The second site has been recruited, and the baseline data collection will start in spring, INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37672.

Background: Normalization Process Theory (NPT) identifies mechanisms that have been demonstrated to play an important role in implementation processes. It is now widely used to inform feasibility, process evaluation, and implementation studies in healthcare and other areas of work. This qualitative synthesis of NPT studies aims to better understand how NPT explains observed and reported implementation processes, and to explore the ways in which its constructs explain the implementability, enacting and sustainment of complex healthcare interventions. Methods: We will systematically search Scopus, PubMed and Web of Science databases and use the Google Scholar search engine for citations of key papers in which NPT was developed. This will identify English language peer-reviewed articles in scientific journals reporting (a) primary qualitative or mixed methods studies; or, (b) qualitative or mixed methods evidence syntheses in which NPT was the primary analytic framework. Studies may be conducted in any healthcare setting, published between June 2006 and 31 December 2021. We will perform a qualitative synthesis of included studies using two parallel methods: (i) directed content analysis based on an already developed coding manual; and (ii) unsupervised textual analysis using Leximancer® topic modelling software. Other: We will disseminate results of the review using peer reviewed publications, conference and seminar presentations, and social media (Facebook and Twitter) channels. The primary source of funding is the National Institute for Health Research ARC North Thames. No human subjects or personal data are involved and no ethical issues are anticipated.

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 evaluat

Introduction Living with and beyond a diagnosis of a low- and intermediate- grade glioma (LIGG) can adversely impact many aspects of people’s lives and their quality of life (QoL). In people with chronic conditions, self- management can improve QoL. This is especially true if people are supported to self- manage. Supported self- management programmes have been developed for several cancers, but the unique challenges experienced by LIGG survivors mean these programmes may not be readily transferable to this group. The Ways Ahead study aims to address this gap by exploring the needs of LIGG survivors to develop a prototype for a supported self- management programme tailored to this group. Methods and analysis Ways Ahead will follow three sequential phases, underpinned by a systematic review of self- management interventions in cancer. In phase 1, qualitative methods will be used to explore and understand the issues faced by LIGG survivors, as well as the barriers and facilitators to self- management. Three sets of interviews will be conducted with LIGG survivors, their informal carers and professionals. Thematic analysis will be conducted with reference to the Theoretical Domains Framework and Normalisation Process Theory. Phase 2 will involve co- production workshops to generate ideas for the design of a supported self- management programme. Workshop outputs will be translated into a design specification for a prototype programme. Finally, phase 3 will involve a health economic assessment to examine the feasibility and benefits of incorporating the proposed programme into the current survivorship care pathway. This prototype will then be ready for testing in a subsequent trial. Ethics and dissemination The study has been reviewed and approved by an National Health Service Research Ethics Committee (REC ref: 20/WA/0118). The findings will be disseminated through peer- reviewed journals, conference presentations, broadcast media, the study website, The Brain Tumour Cha

Background The original British instrument the Normalization Process Theory Measure (NoMAD) is based on the four core constructs of the Normalization Process Theory: Coherence, Cognitive Participation, Collective Action, and Reflexive Monitoring. They represent ways of thinking about implementation and are focused on how interventions can become part of everyday practice. Aim To translate and adapt the original NoMAD into the Swedish version S-NoMAD and to evaluate its psychometric properties based on a pilot test in a health care context including in-hospital, primary, and community care contexts. Methods A systematic approach with a four-step process was utilized, including forward and backward translation and expert reviews for the test and improvement of content validity of the S-NoMAD in different stages of development. The final S-NoMAD version was then used for process evaluation in a pilot study aimed at the implementation of a new working method for individualized care planning. The pilot was executed in two hospitals, four health care centres, and two municipalities in a region in northern Sweden. The S-NoMAD pilot results were analysed for validity using confirmatory factor analysis, i.e. a one-factor model fitted for each of the four constructs of the S-NoMAD. Cronbach’s alpha was used to ascertain the internal consistency reliability. Results In the pilot, S-NoMAD data were collected from 144 individuals who were different health care professionals or managers. The initial factor analysis model showed good fit for two of the constructs (Coherence and Cognitive Participation) and unsatisfactory fit for the remaining two (Collective Action and Reflexive Monitoring) based on three items. Deleting those items from the model yielded a good fit and good internal consistency (alphas between 0.78 and 0.83). However, the estimation of correlations between the factors showed that the factor Reflexive Monitoring was highly correlated (around 0.9) with the factors, Validerad;2019;Nivå 2;2019-01-08 (johcin);Full text license: CC BY

Background Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke. Methods/design Study design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation. Setting: NHS stroke services. Participants: adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation. Randomisation groups: 1. Robot-assisted training using the InMotion robotic gym system for 45 min, three times/week for 12 weeks 2. Enhanced upper limb therapy for 45 min, three times/week for 12 weeks 3. Usual NHS care in accordance with local clinical practice Randomisation: individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment. Primary outcome: upper limb function measured by the Action Research Arm Test (ARAT) at 3 months post randomisation. Secondary outcomes: upper limb impairment (Fugl-Meyer Test), activities of daily living (Barthel ADL Index), quality of life (Stroke Impact Scale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverse events, at 3 and 6 months. Blinding: outcomes are undertaken by blinded assessors. Economic analysis: micro-costing and economic evaluation of interventions compared to usual NHS care. A within-trial analysis, with an economic model will be used to extrapolate longer-term costs and outcomes. Process evaluation: semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided, and factors affecting the implementation of the trial. Sample size: allowing for 10% attrition, 720 participants provide 80% power to detect a 15% difference in successful outcome between each of the treatment pairs. Suc

Background Implementing good-quality health and social care requires empowerment of staff members within organizations delivering care. Video Interaction Guidance (VIG) is an intervention using positive video feedback to empower staff through reflection on practice. This qualitative study explored the implementation of VIG within an autism care organization in England, from the perspective of staff members undergoing training to deliver VIG. Methods Semi-structured interviews were conducted with a purposive sample of 7 participants working within the organization (5 staff undergoing training to deliver VIG; 2 senior managers influencing co-ordination of training). Participants were asked about their views of VIG and its implementation. The topic guide was informed by Normalization Process Theory (NPT). Data were analysed inductively and emerging issues were related to NPT. Results Five broad themes were identified: (1) participants reported that they and other staff did not understand VIG until they became involved, initially believing it would highlight negative rather than positive practice; (2) enthusiastic feedback from staff who had been involved seemed to encourage other staff to become involved; (3) key implementation challenges included demands of daily work and securing managers’ support; (4) ideas for future practice arising from empowerment through VIG seemed difficult to realise within an organizational culture reportedly unreceptive to creative ideas from staff; (5) individuals’ emotional responses to implementation seemed beyond the reach of NPT, which focused more upon collective processes. Conclusions Implementation of VIG may require recognition that it is not a ‘quick fix’. Peer advocacy may be a fruitful implementation strategy. Senior managers may need to experience VIG to develop their understanding so that they can provide appropriate implementation support. NPT may lack specificity to explain how individual agency weaves with collective proces

The emergence of the field of health care at a distance, or 'telehealth', has been embedded within discourses of high ambition about health improvement, seamless services, empowerment, and independence for patients. In this article, the authors examine how telehealthcare technologies assume certain forms of patients-or 'telepatients'-who can be mobilized and combined with images and artifacts that speak for them in the clinical encounter. Second, a tentative intervention is made in these emerging identities in the form of facilitating some alternative discourses about telehealthcare. The aim is to stimulate debate by presenting and contrasting these different approaches to technology development. Such differences take material and discursive shape in the making and unmaking of telepatients, showing important interferences in the shaping of identity and possibilities for governance and participation.

Increasing use of information and communication technologies is said to be transforming health care. Telehealthcare enables medical consultations to be conducted between patients and health professionals across different locations. Such technologies imply new relationships between patients and health professionals. This study aimed to understand how policy and practice in relation to telehealthcare suggests new conceptualisations of 'the patient'. In-depth semistructured interviews (n = 38) were conducted with key informants from across the UK, known to have involvement or interest in telehealthcare from a variety of perspectives: health professionals (n = 11), patient advocates (n = 7), telemedicine experts (n = 6), policy-makers (n = 4), administrators (n = 4), researchers (n = 3) and technologists (n = 3). Interviews were conducted either in person or over the telephone, and were audio-recorded. Data were analysed thematically with ongoing cross-validation of data interpretation between members of the research team. The results indicated divergent views about the role of the patient, although accounts of patients becoming 'educated self-managers', taking on a more active role in their healthcare, were predominant. Beliefs about the impact of telehealthcare on patients were focused on perceived 'priorities' such as access, location of services, confidentiality and choice; however, there remains little understanding of the trade-offs that patients are willing to make in the context of technologically mediated health care. The results also highlight ideas around how patients relate to technologies; the extent to which technologies might fragment care and medicine in new or unexpected ways, and participation and absence of patients in decision-making about policies and services. The results of this study have important implications for the ways in which relationships between health professionals and patients are managed in practice, and raise important questions for

'Modernization' is a key health policy objective in the UK. It extends across a range of public service delivery and organizational contexts, and also means there are radical changes in perspective on professional behaviour and practice. New information and communications technologies have been seen as one of the key mechanisms by which these changes can be engendered. In particular, massive investment in information technologies promises the rapid distribution and deployment of patient-centred information across internal organizational boundaries. While the National Health Service (NHS) sits on the edge of a £6billion investment in electronic patient records, other technologies find their status as innovative vehicles for professional behaviour change and service delivery in question. In this paper, we consider the ways that telemedicine and telehealthcare systems have been constructed first as a field of technological innovation, and more recently, as management solutions to problems around the distribution of health care. We use NHS responses to chronic illness as a medium for understanding these shifts. In particular, we draw attention to the shifting definitions of 'innovation' and to the ways that these shifts define a move away from notions of technological advance towards management control.

Ten delegates at the conference Voluntarism, Health and Social Care were recruited to form a panel of citizens to debate and offer direction for the future of technologically mediated health care. The panel suggested various principles for the development of telemedicine and telecare, concerning: patients, users and carers, approach to service delivery, research and knowledge, and conditions of use. Many of the principles echoed the founding values of the National Health Service, yet have arguably been absent from both policy pronouncements and the telemedicine literature, which largely views new health technologies themselves as 'value free', i.e. developed untouched by social and political relations. A programme of citizens' panels should be developed so that an informed debate can take place about the development of telemedicine and telecare, to underpin policy and practice.

We conducted a qualitative study in the UK to examine perspectives about telemedicine, telecare and e-health for the changing roles of patients and citizens. We believe there are important differences between these applications, but for simplicity, the term 'telecare' is used broadly here to include all three. In-depth, semistructured interviews were conducted between September 2002 and May 2004. Participants were 38 key informants from the UK, known to have involvement or interest in telecare: policy-makers, clinicians, technologists, health service managers, researchers and patient advocates. Interviews were conducted either in person or over the telephone, and were audio-recorded with participants' consent. The most frequently cited priorities for patients included accessibility to services, locations of care and quality of care, with some respondents emphasizing the importance of choice for the patient (in terms of appointments and ways of accessing services). However, telecare has implications for patients that go beyond issues of access. A major problem is that 'priorities' are assumed rather than based on an empirical understanding; moreover, for individual patients, preferences for particular forms of service delivery are likely to represent trade-offs between multiple priorities. The findings of the present study confirm that concepts of the patient's rights and responsibilities are changing with the increasing use of new technologies to deliver health care.

Ten delegates at the conference Voluntarism, Health and Social Care were recruited to form a panel of citizens to debate and offer direction for the future of technologically mediated health care. The panel suggested various principles for the development of telemedicine and telecare, concerning: patients, users and carers, approach to service delivery, research and knowledge, and conditions of use. Many of the principles echoed the founding values of the National Health Service, yet have arguably been absent from both policy pronouncements and the telemedicine literature, which largely views new health technologies themselves as 'value free', i.e. developed untouched by social and political relations. A programme of citizens' panels should be developed so that an informed debate can take place about the development of telemedicine and telecare, to underpin policy and practice.

We conducted a qualitative study in the UK to examine perspectives about telemedicine, telecare and e-health for the changing roles of patients and citizens. We believe there are important differences between these applications, but for simplicity, the term 'telecare' is used broadly here to include all three. In-depth, semistructured interviews were conducted between September 2002 and May 2004. Participants were 38 key informants from the UK, known to have involvement or interest in telecare: policy-makers, clinicians, technologists, health service managers, researchers and patient advocates. Interviews were conducted either in person or over the telephone, and were audio-recorded with participants' consent. The most frequently cited priorities for patients included accessibility to services, locations of care and quality of care, with some respondents emphasizing the importance of choice for the patient (in terms of appointments and ways of accessing services). However, telecare has implications for patients that go beyond issues of access. A major problem is that 'priorities' are assumed rather than based on an empirical understanding; moreover, for individual patients, preferences for particular forms of service delivery are likely to represent trade-offs between multiple priorities. The findings of the present study confirm that concepts of the patient's rights and responsibilities are changing with the increasing use of new technologies to deliver health care.

Objectives To identify issues that facilitate the successful integration of evaluation and development of telehealthcare services. Design Ethnographic study using various qualitative research techniques to obtain data from several sources, including in-depth semistructured interviews, project steering group meetings, and public telehealthcare meetings. Setting Seven telehealthcare evaluation projects (four randomised controlled trials and three pragmatic service evaluations) in the United Kingdom, studied over two years. Projects spanned a range of specialties—dermatology, psychiatry, respiratory medicine, cardiology, and oncology. Participants Clinicians, managers, technical experts, and researchers involved in the projects. Results and discussion Key problems in successfully integrating evaluation and service development in telehealthcare are, firstly, defining existing clinical practices (and anticipating changes) in ways that permit measurement; secondly, managing additional workload and conflicting responsibilities brought about by combining clinical and research responsibilities (including managing risk); and, thirdly, understanding various perspectives on effectiveness and the limitations of evaluation results beyond the context of the research study. Conclusions Combined implementation and evaluation of telehealthcare systems is complex, and is often underestimated. The distinction between quantitative outcomes and the workability of the system is important for producing evaluative knowledge that is of practical value. More pragmatic approaches to evaluation, that permit both quantitative and qualitative methods, are required to improve the quality of such research and its relevance for service provision in the NHS.

peer-reviewed, 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.

peer-reviewed, Background: Normalization Process Theory (NPT) can be used to explain implementation processes in health care relating to new technologies and complex interventions. This paper describes the processes by which we developed a simplified version of NPT for use by clinicians, managers, and policy makers, and which could be embedded in a web-enabled toolkit and on-line users manual. Methods: Between 2006 and 2010 we undertook four tasks. (i) We presented NPT to potential and actual users in multiple workshops, seminars, and presentations. (ii) Using what we discovered from these meetings, we decided to create a simplified set of statements and explanations expressing core constructs of the theory (iii) We circulated these statements to a criterion sample of 60 researchers, clinicians and others, using SurveyMonkey to collect qualitative textual data about their criticisms of the statements. (iv) We then reconstructed the statements and explanations to meet users’ criticisms, embedded them in a web-enabled toolkit, and beta tested this ‘in the wild’. Results: On-line data collection was effective: over a four week period 50/60 participants responded using SurveyMonkey (40/60) or direct phone and email contact (10/60). An additional nine responses were received from people who had been sent the SurveyMonkey form by other respondents. Beta testing of the web enabled toolkit produced 13 responses, from 327 visits to http://www.normalizationprocess.org. Qualitative analysis of both sets of responses showed a high level of support for the statements but also showed that some statements poorly expressed their underlying constructs or overlapped with others. These were rewritten to take account of users’ criticisms and then embedded in a web-enabled toolkit. As a result we were able translate the core constructs into a simplified set of statements that could be utilized by non-experts. Conclusion: Normalization Process Theory has been developed through transparent procedures at

peer-reviewed, Background: The Normalization Process Model is a theoretical model that assists in explaining the processes by which complex interventions become routinely embedded in health care practice. It offers a framework for process evaluation and also for comparative studies of complex interventions. It focuses on the factors that promote or inhibit the routine embedding of complex interventions in health care practice. Methods: A formal theory structure is used to define the model, and its internal causal relations and mechanisms. The model is broken down to show that it is consistent and adequate in generating accurate description, systematic explanation, and the production of rational knowledge claims about the workability and integration of complex interventions. Results: The model explains the normalization of complex interventions by reference to four factors demonstrated to promote or inhibit the operationalization and embedding of complex interventions (interactional workability, relational integration, skill-set workability, and contextual integration). Conclusion: The model is consistent and adequate. Repeated calls for theoretically sound process evaluations in randomized controlled trials of complex interventions, and policy-makers who call for a proper understanding of implementation processes, emphasize the value of conceptual tools like the Normalization Process Model.

peer-reviewed, Background: Theories are important tools in the social and natural sciences. The methods by which they are derived are rarely described and discussed. Normalization Process Theory explains how new technologies, ways of acting, and ways of working become routinely embedded in everyday practice, and has applications in the study of implementation processes. This paper describes the process by which it was built. Methods: Between 1998 and 2008, we developed a theory. We derived a set of empirical generalizations from analysis of data collected in qualitative studies of healthcare work and organization. We developed an applied theoretical model through analysis of empirical generalizations. Finally, we built a formal theory through a process of extension and implication analysis of the applied theoretical model. Results: Each phase of theory development showed that the constructs of the theory did not conflict with each other, had explanatory power, and possessed sufficient robustness for formal testing. As the theory developed, its scope expanded from a set of observed regularities in data with procedural explanations, to an applied theoretical model, to a formal middle-range theory. Conclusion: Normalization Process Theory has been developed through procedures that were properly sceptical and critical, and which were opened to review at each stage of development. The theory has been shown to merit formal testing.

peer-reviewed, 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 confguration of realist evaluation studies. Contexts are defned as settings in which implementation work is done, in which strategic intentions, adaptive execution, negotiating capability, and refram ing organisational logics are enacted. Mechanisms are defned as the work that people do when they participate in implementation processes and include coherence-building, cognitive participation, collective action, and refexive monitoring. Outcomes are defned as efects 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 m