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1.  Delivering digital health and well-being at scale: lessons learned during the implementation of the dallas program in the United Kingdom 
Objective To identify implementation lessons from the United Kingdom Delivering Assisted Living Lifestyles at Scale (dallas) program—a large-scale, national technology program that aims to deliver a broad range of digital services and products to the public to promote health and well-being.
Materials and Methods Prospective, longitudinal qualitative research study investigating implementation processes. Qualitative data collected includes semi-structured e-Health Implementation Toolkit–led interviews at baseline/mid-point (n = 38), quarterly evaluation, quarterly technical and barrier and solutions reports, observational logs, quarterly evaluation alignment interviews with project leads, observational data collected during meetings, and ethnographic data from dallas events (n > 200 distinct pieces of qualitative data). Data analysis was guided by Normalization Process Theory, a sociological theory that aids conceptualization of implementation issues in complex healthcare settings.
Results Five key challenges were identified: 1) The challenge of establishing and maintaining large heterogeneous, multi-agency partnerships to deliver new models of healthcare; 2) The need for resilience in the face of barriers and set-backs including the backdrop of continually changing external environments; 3) The inherent tension between embracing innovative co-design and achieving delivery at pace and at scale; 4) The effects of branding and marketing issues in consumer healthcare settings; and 5) The challenge of interoperability and information governance, when commercial proprietary models are dominant.
Conclusions The magnitude and ambition of the dallas program provides a unique opportunity to investigate the macro level implementation challenges faced when designing and delivering digital health and wellness services at scale. Flexibility, adaptability, and resilience are key implementation facilitators when shifting to new digitally enabled models of care.
doi:10.1093/jamia/ocv097
PMCID: PMC4713902  PMID: 26254480
consumer health informatics; eHealth implementation; assistive living technologies; electronic health records; mHealth
3.  Understanding factors affecting patient and public engagement and recruitment to digital health interventions: a systematic review of qualitative studies 
Background
Numerous types of digital health interventions (DHIs) are available to patients and the public but many factors affect their ability to engage and enrol in them. This systematic review aims to identify and synthesise the qualitative literature on barriers and facilitators to engagement and recruitment to DHIs to inform future implementation efforts.
Methods
PubMed, MEDLINE, CINAHL, Embase, Scopus and the ACM Digital Library were searched for English language qualitative studies from 2000 – 2015 that discussed factors affecting engagement and enrolment in a range of DHIs (e.g. ‘telemedicine’, ‘mobile applications’, ‘personal health record’, ‘social networking’). Text mining and additional search strategies were used to identify 1,448 records. Two reviewers independently carried out paper screening, quality assessment, data extraction and analysis. Data was analysed using framework synthesis, informed by Normalization Process Theory, and Burden of Treatment Theory helped conceptualise the interpretation of results.
Results
Nineteen publications were included in the review. Four overarching themes that affect patient and public engagement and enrolment in DHIs emerged; 1) personal agency and motivation; 2) personal life and values; 3) the engagement and recruitment approach; and 4) the quality of the DHI. The review also summarises engagement and recruitment strategies used. A preliminary DIgital Health EnGagement MOdel (DIEGO) was developed to highlight the key processes involved. Existing knowledge gaps are identified and a number of recommendations made for future research. Study limitations include English language publications and exclusion of grey literature.
Conclusion
This review summarises and highlights the complexity of digital health engagement and recruitment processes and outlines issues that need to be addressed before patients and the public commit to digital health and it can be implemented effectively. More work is needed to create successful engagement strategies and better quality digital solutions that are personalised where possible and to gain clinical accreditation and endorsement when appropriate. More investment is also needed to improve computer literacy and ensure technologies are accessible and affordable for those who wish to sign up to them.
Systematic review registration
International Prospective Register of Systematic Reviews CRD42015029846
Electronic supplementary material
The online version of this article (doi:10.1186/s12911-016-0359-3) contains supplementary material, which is available to authorized users.
doi:10.1186/s12911-016-0359-3
PMCID: PMC5024516  PMID: 27630020
Digital health; eHealth; Electronic health records; Telemedicine; Mobile applications; mHealth; Engagement; Recruitment; Barrier; Facilitator
4.  Barriers and facilitators to patient and public engagement and recruitment to digital health interventions: protocol of a systematic review of qualitative studies 
BMJ Open  2016;6(9):e010895.
Introduction
Patients and the public are beginning to use digital health tools to assist in managing chronic illness, support independent living and self-care, and remain connected to health and care providers. However, engaging with and enrolling in digital health interventions, such as telehealth systems, mobile health applications, patient portals and personal health records, in order to use them varies considerably. Many factors affect people's ability to engage with and sign up to digital health platforms.
Objectives
The primary aim is to identify the barriers and facilitators patients and the public experience to engagement and recruitment to digital health interventions. The secondary aim is to identify engagement and enrolment strategies, leading if possible to a taxonomy of such approaches, and a conceptual framework of digital health engagement and recruitment processes.
Methods
A systematic review of qualitative studies will be conducted by searching six databases: MEDLINE, CINAHL, PubMed, EMBASE, Scopus and the ACM Digital Library for papers published between 2000 and 2015. Titles and abstracts along with full-text papers will be screened by two independent reviewers against predetermined inclusion and exclusion criteria. A data extraction form will be used to provide details of the included studies. Quality assessment will be conducted using the Consolidated Criteria for Reporting Qualitative Research checklist. Any disagreements will be resolved through discussion with an independent third reviewer. Analysis will be guided by framework synthesis and informed by normalization process theory and burden of treatment theory, to aid conceptualisation of digital health engagement and recruitment processes.
Discussion
This systematic review of qualitative studies will explore factors affecting engagement and enrolment in digital health interventions. It will advance our understanding of readiness for digital health by examining the complex factors that affect patients’ and the public's ability to take part.
Trial registration number
CRD42015029846.
doi:10.1136/bmjopen-2015-010895
PMCID: PMC5020860  PMID: 27591017
digital health; eHealth; recruitment; engagement; systematic review
5.  Learning from doing: the case for combining normalisation process theory and participatory learning and action research methodology for primary healthcare implementation research 
Background
The implementation of research findings is not a straightforward matter. There are substantive and recognised gaps in the process of translating research findings into practice and policy. In order to overcome some of these translational difficulties, a number of strategies have been proposed for researchers. These include greater use of theoretical approaches in research focused on implementation, and use of a wider range of research methods appropriate to policy questions and the wider social context in which they are placed. However, questions remain about how to combine theory and method in implementation research. In this paper, we respond to these proposals.
Discussion
Focussing on a contemporary social theory, Normalisation Process Theory, and a participatory research methodology, Participatory Learning and Action, we discuss the potential of their combined use for implementation research. We note ways in which Normalisation Process Theory and Participatory Learning and Action are congruent and may therefore be used as heuristic devices to explore, better understand and support implementation. We also provide examples of their use in our own research programme about community involvement in primary healthcare.
Conclusions
Normalisation Process Theory alone has, to date, offered useful explanations for the success or otherwise of implementation projects post-implementation. We argue that Normalisation Process Theory can also be used to prospectively support implementation journeys. Furthermore, Normalisation Process Theory and Participatory Learning and Action can be used together so that interventions to support implementation work are devised and enacted with the expertise of key stakeholders. We propose that the specific combination of this theory and methodology possesses the potential, because of their combined heuristic force, to offer a more effective means of supporting implementation projects than either one might do on its own, and of providing deeper understandings of implementation contexts, rather than merely describing change.
Electronic supplementary material
The online version of this article (doi:10.1186/s12913-016-1587-z) contains supplementary material, which is available to authorized users.
doi:10.1186/s12913-016-1587-z
PMCID: PMC4972957  PMID: 27488361
Primary  healthcare, participatory learning & action research; Normalisation process theory; Implementation research; Theoretical frameworks
6.  Engaging migrants and other stakeholders to improve communication in cross-cultural consultation in primary care: a theoretically informed participatory study 
BMJ Open  2016;6(7):e010822.
Objectives
Guidelines and training initiatives (G/TIs) are available to support communication in cross-cultural consultations but are rarely implemented in routine practice in primary care. As part of the European Union RESTORE project, our objective was to explore whether the available G/TIs make sense to migrants and other key stakeholders and whether they could collectively choose G/TIs and engage in their implementation in primary care settings.
Setting
As part of a comparative analysis of 5 linked qualitative case studies, we used purposeful and snowball sampling to recruit migrants and other key stakeholders in primary care settings in Austria, England, Greece, Ireland and the Netherlands.
Participants
A total of 78 stakeholders participated in the study (Austria 15, England 9, Ireland 11, Greece 16, Netherlands 27), covering a range of groups (migrants, general practitioners, nurses, administrative staff, interpreters, health service planners).
Primary and secondary outcome measures
We combined Normalisation Process Theory (NPT) and Participatory Learning and Action (PLA) research to conduct a series of PLA style focus groups. Using a standardised protocol, stakeholders' discussions about a set of G/TIs were recorded on PLA commentary charts and their selection process was recorded through a PLA direct-ranking technique. We performed inductive and deductive thematic analysis to investigate sensemaking and engagement with the G/TIs.
Results
The need for new ways of working was strongly endorsed by most stakeholders. Stakeholders considered that they were the right people to drive the work forward and were keen to enrol others to support the implementation work. This was evidenced by the democratic selection by stakeholders in each setting of one G/TI as a local implementation project.
Conclusions
This theoretically informed participatory approach used across 5 countries with diverse healthcare systems could be used in other settings to establish positive conditions for the start of implementation journeys for G/TIs to improve healthcare for migrants.
doi:10.1136/bmjopen-2015-010822
PMCID: PMC4964217  PMID: 27449890
PRIMARY CARE; cross-cultural consultation; migrant health; community involvement
8.  Reducing dementia risk by targeting modifiable risk factors in mid-life: study protocol for the Innovative Midlife Intervention for Dementia Deterrence (In-MINDD) randomised controlled feasibility trial 
Background
Dementia prevalence is increasing as populations live longer, with no cure and the costs of caring exceeding many other conditions. There is increasing evidence for modifiable risk factors which, if addressed in mid-life, can reduce the risk of developing dementia in later life. These include physical inactivity, low cognitive activity, mid-life obesity, high blood pressure, and high cholesterol. This study aims to assess the acceptability and feasibility and impact of giving those in mid-life, aged between 40 and 60 years, an individualised dementia risk modification score and profile and access to personalised on-line health information and goal setting in order to support the behaviour change required to reduce such dementia risk. A secondary aim is to understand participants’ and practitioners’ views of dementia prevention and explore the acceptability and integration of the Innovative Midlife Intervention for Dementia Deterrence (In-MINDD) intervention into daily life and routine practice.
Methods/design
In-MINDD is a multi-centre, primary care-based, single-blinded randomised controlled feasibility trial currently being conducted in four European countries (France, Ireland, the Netherlands and the UK). Participants are being recruited from participating general practices. Inclusion criteria will include age between 40 and 60 years; at least one modifiable risk factor for dementia risk (including diabetes, hypertension, obesity, renal dysfunction, current smoker, raised cholesterol, coronary heart disease, current or previous history of depression, self-reported sedentary lifestyle, and self-reported low cognitive activity) access to the Internet. Primary outcome measure will be a change in dementia risk modification score over the timescale of the trial (6 months). A qualitative process evaluation will interview a sample of participants and practitioners about their views on the acceptability and feasibility of the trial and the links between modifiable risk factors and dementia prevention. This work will be underpinned by Normalisation Process Theory.
Discussion
This study will explore the feasibility and acceptability of a risk profiler and on-line support environment to help individuals in mid-life assess their risk of developing dementia in later life and to take steps to alleviate that risk by tackling health-related behaviour change. Testing the intervention in a robust and theoretically informed manner will inform the development of a future, full-scale randomised controlled trial.
Trial registration
ISRCTN Registry: ISRCTN 98553005 (DOI: 10.1186/ISRCTN98553005).
Electronic supplementary material
The online version of this article (doi:10.1186/s40814-015-0035-x) contains supplementary material, which is available to authorized users.
doi:10.1186/s40814-015-0035-x
PMCID: PMC5154057  PMID: 27965818
Dementia; Primary prevention; Modifiable risk factors; Internet; Primary care
9.  Interventions targeted at primary care practitioners to improve the identification and referral of patients with co-morbid obesity: a realist review protocol 
Systematic Reviews  2015;4:61.
Background
Obesity is one of the most significant public health challenges in the developed world. Recent policy has suggested that more can be done in primary care to support adults with obesity. In particular, general practitioners (GPs) and practice nurses (PNs) could improve the identification and referral of adults with obesity to appropriate weight management services. Previous interventions targeted at primary care practitioners in this area have had mixed results, suggesting a more complex interplay between patients, practitioners, and systems. The objectives of this review are (i) to identify the underlying ‘programme theory’ of interventions targeted at primary care practitioners to improve the identification and referral of adults with obesity and (ii) to explore how and why GPs and PNs identify and refer individuals with obesity, particularly in the context of weight-related co-morbidity. This protocol will explain the rationale for using a realist review approach and outline the key steps in this process.
Methods
Realist review is a theory-led approach to knowledge synthesis that provides an explanatory analysis aimed at discerning what works, for whom, in what circumstances, how, and why. In this review, scoping interviews with key stakeholders involved in the planning and delivery of adult weight management services in Scotland helped to inform the identification of formal theories - from psychology, sociology, and implementation science - that will be tested as the review progresses. A comprehensive search strategy is described, including scope for iterative searching. Data analysis is outlined in three stages (describing context-mechanism-outcome configurations, exploring patterns in these configurations, and developing and testing middle-range theories, informed by the formal theories previously identified), culminating in the production of explanatory programme theory that considers individual, interpersonal, and institutional/systems-level components.
Discussion
This is the first realist review that we are aware of looking at interventions targeted at primary care practitioners to improve the weight management of adults with obesity. Engagement with stakeholders at an early stage is a unique feature of realist review. This shapes the scope of the review, identification of candidate theories and dissemination strategies. The findings of this review will inform policy and future interventions.
Systematic review registration
PROSPERO CRD42014009391
Electronic supplementary material
The online version of this article (doi:10.1186/s13643-015-0046-y) contains supplementary material, which is available to authorized users.
doi:10.1186/s13643-015-0046-y
PMCID: PMC4426175  PMID: 25927993
Realist review; Realist synthesis; Obesity; Primary care; General practitioners; Practice nurses; Referral; Weight management; Effectiveness
10.  Developing a preliminary ‘never event’ list for general practice using consensus-building methods 
The British Journal of General Practice  2014;64(620):e159-e167.
Background
The ‘never event’ concept has been implemented in many acute hospital settings to help prevent serious patient safety incidents. Benefits include increasing awareness of highly important patient safety risks among the healthcare workforce, promoting proactive implementation of preventive measures, and facilitating incident reporting.
Aim
To develop a preliminary list of never events for general practice.
Design and setting
Application of a range of consensus-building methods in Scottish and UK general practices.
Method
A total of 345 general practice team members suggested potential never events. Next, ‘informed’ staff (n =15) developed criteria for defining never events and applied the criteria to create a list of candidate never events. Finally, UK primary care patient safety ‘experts’ (n = 17) reviewed, refined, and validated a preliminary list via a modified Delphi group and by completing a content validity index exercise.
Results
There were 721 written suggestions received as potential never events. Thematic categorisation reduced this to 38. Five criteria specific to general practice were developed and applied to produce 11 candidate never events. The expert group endorsed a preliminary list of 10 items with a content validity index (CVI) score of >80%.
Conclusion
A preliminary list of never events was developed for general practice through practitioner experience and consensus-building methods. This is an important first step to determine the potential value of the never event concept in this setting. It is now intended to undertake further testing of this preliminary list to assess its acceptability, feasibility, and potential usefulness as a safety improvement intervention.
doi:10.3399/bjgp14X677536
PMCID: PMC3933834  PMID: 24567655
general practice; never events; patient safety; primary care
11.  A qualitative systematic review of studies using the normalization process theory to research implementation processes 
Background
There is a well-recognized need for greater use of theory to address research translational gaps. Normalization Process Theory (NPT) provides a set of sociological tools to understand and explain the social processes through which new or modified practices of thinking, enacting, and organizing work are implemented, embedded, and integrated in healthcare and other organizational settings. This review of NPT offers readers the opportunity to observe how, and in what areas, a particular theoretical approach to implementation is being used. In this article we review the literature on NPT in order to understand what interventions NPT is being used to analyze, how NPT is being operationalized, and the reported benefits, if any, of using NPT.
Methods
Using a framework analysis approach, we conducted a qualitative systematic review of peer-reviewed literature using NPT. We searched 12 electronic databases and all citations linked to six key NPT development papers. Grey literature/unpublished studies were not sought. Limitations of English language, healthcare setting and year of publication 2006 to June 2012 were set.
Results
Twenty-nine articles met the inclusion criteria; in the main, NPT is being applied to qualitatively analyze a diverse range of complex interventions, many beyond its original field of e-health and telehealth. The NPT constructs have high stability across settings and, notwithstanding challenges in applying NPT in terms of managing overlaps between constructs, there is evidence that it is a beneficial heuristic device to explain and guide implementation processes.
Conclusions
NPT offers a generalizable framework that can be applied across contexts with opportunities for incremental knowledge gain over time and an explicit framework for analysis, which can explain and potentially shape implementation processes. This is the first review of NPT in use and it generates an impetus for further and extended use of NPT. We recommend that in future NPT research, authors should explicate their rationale for choosing NPT as their theoretical framework and, where possible, involve multiple stakeholders including service users to enable analysis of implementation from a range of perspectives.
doi:10.1186/1748-5908-9-2
PMCID: PMC3905960  PMID: 24383661
Implementation; Policy; Normalization process theory; Theory; Translational gaps
12.  Delivering a national programme of anticipatory care in primary care: a qualitative study 
The British Journal of General Practice  2012;62(597):e288-e296.
Background
Primary prevention often occurs against a background of inequalities in health and health care. Addressing this requires practitioners and systems to acknowledge the contribution of health-related and social determinants and to deal with the lack of interconnectedness between health and social service providers. Recognising this, the Scottish Government has implemented a national programme of anticipatory care targeting individuals aged 45–64 years living in areas of socioeconomic deprivation and at high risk of cardiovascular disease. This programme is called Keep Well.
Aim
To explore the issues and tensions underpinning the implementation of a national programme of anticipatory care.
Design and setting
A qualitative study in five Wave 1 Keep Well pilot sites, located in urban areas of Scotland, and involving 79 general practices.
Method
Annual semi-structured interviews were conducted with 74 key stakeholders operating at national government level, local pilot level and within general practices, resulting in 118 interviews. Interview transcripts were analysed using the framework approach.
Results
Four underlying tensions were identified. First, those between a patient-focused general-practice approach versus a population-level health-improvement approach, linking disparate health and social services; secondly, medical approaches versus wider social approaches; thirdly, a population-wide approach versus individual targeting; and finally, reactive versus anticipatory care.
Conclusion
Implementing an anticipatory care programme to address inequalities in cardiovascular disease identified several tensions, which need to be understood and resolved in order to inform the development of such approaches in general practice and to develop systems that reduce the degree of fragmentation across health and social services.
doi:10.3399/bjgp12X636137
PMCID: PMC3310036  PMID: 22520917
anticipatory care; cardiovascular diseases; inequalities, health; primary prevention. decision-making
13.  Can we quantify harm in general practice records? An assessment of precision and power using computer simulation 
Background
Estimating harm rates for specific patient populations and detecting significant changes in them over time are essential if patient safety in general practice is to be improved. Clinical record review (CRR) is arguably the most suitable method for these purposes, but the optimal values and combinations of its parameters (such as numbers of records and practices) remain unknown. Our aims were to: 1. Determine and quantify CRR parameters; 2. Assess the precision and power of feasible CRR scenarios; and 3. Quantify the minimum requirements for adequate precision and acceptable power.
Method
We explored precision and power of CRR scenarios using Monte Carlo simulation. A range of parameter values were combined in 864 different CRR scenarios, with 1000 random data sets generated for each, and harm rates were estimated and tested for change over time by fitting a generalised linear model with a Poisson response.
Results
CRR scenarios with ≥100 detected harm incidents had harm rate estimates with acceptable precision. Harm reductions of 20% or ≥50% were detected with adequate power by those CRR scenarios with at least 100 and 500 harm incidents respectively. The number of detected harm incidents was dependent on the baseline harm rate multiplied by: the period of time reviewed in each record; number of records reviewed per practice; number of practices who reviewed records; and the number of times each record was reviewed.
Conclusion
We developed a simple formula to calculate the minimum values of CRR parameters required to achieve adequate precision and acceptable power when monitoring harm rates. Our findings have practical implications for health care decision-makers, leaders and researchers aiming to measure and reduce harm at regional or national level.
doi:10.1186/1471-2288-13-39
PMCID: PMC3635932  PMID: 23497099
Patient safety; General practice; Primary care; Trigger tool; Clinical record review; Precision; Power; Harm
14.  REsearch into implementation STrategies to support patients of different ORigins and language background in a variety of European primary care settings (RESTORE): study protocol 
Background
The implementation of guidelines and training initiatives to support communication in cross-cultural primary care consultations is ad hoc across a range of international settings with negative consequences particularly for migrants. This situation reflects a well-documented translational gap between evidence and practice and is part of the wider problem of implementing guidelines and the broader range of professional educational and quality interventions in routine practice. In this paper, we describe our use of a contemporary social theory, Normalization Process Theory and participatory research methodology—Participatory Learning and Action—to investigate and support implementation of such guidelines and training initiatives in routine practice.
Methods
This is a qualitative case study, using multiple primary care sites across Europe. Purposive and maximum variation sampling approaches will be used to identify and recruit stakeholders—migrant service users, general practitioners, primary care nurses, practice managers and administrative staff, interpreters, cultural mediators, service planners, and policy makers. We are conducting a mapping exercise to identify relevant guidelines and training initiatives. We will then initiate a PLA-brokered dialogue with stakeholders around Normalization Process Theory’s four constructs—coherence, cognitive participation, collective action, and reflexive monitoring. Through this, we will enable stakeholders in each setting to select a single guideline or training initiative for implementation in their local setting. We will prospectively investigate and support the implementation journeys for the five selected interventions. Data will be generated using a Participatory Learning and Action approach to interviews and focus groups. Data analysis will follow the principles of thematic analysis, will occur in iterative cycles throughout the project and will involve participatory co-analysis with key stakeholders to enhance the authenticity and veracity of findings.
Discussion
This research employs a unique combination of Normalization Process Theory and Participatory Learning and Action, which will provide a novel approach to the analysis of implementation journeys. The findings will advance knowledge in the field of implementation science because we are using and testing theoretical and methodological approaches so that we can critically appraise their scope to mediate barriers and improve the implementation processes.
doi:10.1186/1748-5908-7-111
PMCID: PMC3541149  PMID: 23167911
15.  Boundaries and e-health implementation in health and social care 
Background
The major problem facing health and social care systems globally today is the growing challenge of an elderly population with complex health and social care needs. A longstanding challenge to the provision of high quality, effectively coordinated care for those with complex needs has been the historical separation of health and social care. Access to timely and accurate data about patients and their treatments has the potential to deliver better care at less cost.
Methods
To explore the way in which structural, professional and geographical boundaries have affected e-health implementation in health and social care, through an empirical study of the implementation of an electronic version of Single Shared Assessment (SSA) in Scotland, using three retrospective, qualitative case studies in three different health board locations.
Results
Progress in effectively sharing electronic data had been slow and uneven. One cause was the presence of established structural boundaries, which lead to competing priorities, incompatible IT systems and infrastructure, and poor cooperation. A second cause was the presence of established professional boundaries, which affect staffs’ understanding and acceptance of data sharing and their information requirements. Geographical boundaries featured but less prominently and contrasting perspectives were found with regard to issues such as co-location of health and social care professionals.
Conclusions
To provide holistic care to those with complex health and social care needs, it is essential that we develop integrated approaches to care delivery. Successful integration needs practices such as good project management and governance, ensuring system interoperability, leadership, good training and support, together with clear efforts to improve working relations across professional boundaries and communication of a clear project vision. This study shows that while technological developments make integration possible, long-standing boundaries constitute substantial risks to IT implementations across the health and social care interface which those initiating major changes would do well to consider before committing to the investment.
doi:10.1186/1472-6947-12-100
PMCID: PMC3465217  PMID: 22958223
16.  From theory to 'measurement' in complex interventions: Methodological lessons from the development of an e-health normalisation instrument 
Background
Although empirical and theoretical understanding of processes of implementation in health care is advancing, translation of theory into structured measures that capture the complex interplay between interventions, individuals and context remain limited. This paper aimed to (1) describe the process and outcome of a project to develop a theory-based instrument for measuring implementation processes relating to e-health interventions; and (2) identify key issues and methodological challenges for advancing work in this field.
Methods
A 30-item instrument (Technology Adoption Readiness Scale (TARS)) for measuring normalisation processes in the context of e-health service interventions was developed on the basis on Normalization Process Theory (NPT). NPT focuses on how new practices become routinely embedded within social contexts. The instrument was pre-tested in two health care settings in which e-health (electronic facilitation of healthcare decision-making and practice) was used by health care professionals.
Results
The developed instrument was pre-tested in two professional samples (N = 46; N = 231). Ratings of items representing normalisation ‘processes’ were significantly related to staff members’ perceptions of whether or not e-health had become ‘routine’. Key methodological challenges are discussed in relation to: translating multi-component theoretical constructs into simple questions; developing and choosing appropriate outcome measures; conducting multiple-stakeholder assessments; instrument and question framing; and more general issues for instrument development in practice contexts.
Conclusions
To develop theory-derived measures of implementation process for progressing research in this field, four key recommendations are made relating to (1) greater attention to underlying theoretical assumptions and extent of translation work required; (2) the need for appropriate but flexible approaches to outcomes measurement; (3) representation of multiple perspectives and collaborative nature of work; and (4) emphasis on generic measurement approaches that can be flexibly tailored to particular contexts of study.
doi:10.1186/1471-2288-12-69
PMCID: PMC3473304  PMID: 22594537
17.  What is the 'problem' that outreach work seeks to address and how might it be tackled? Seeking theory in a primary health prevention programme 
Background
Preventive approaches to health are disproportionately accessed by the more affluent and recent health improvement policy advocates the use of targeted preventive primary care to reduce risk factors in poorer individuals and communities. Outreach has become part of the health service response. Outreach has a long history of engaging those who do not otherwise access services. It has, however, been described as eclectic in its purpose, clientele and mode of practice; its effectiveness is unproven.
Using a primary prevention programme in the UK as a case, this paper addresses two research questions: what are the perceived problems of non-engagement that outreach aims to address; and, what specific mechanisms of outreach are hypothesised to tackle these.
Methods
Drawing on a wider programme evaluation, the study undertook qualitative interviews with strategically selected health-care professionals. The analysis was thematically guided by the concept of 'candidacy' which theorises the dynamic process through which services and individuals negotiate appropriate service use.
Results
The study identified seven types of engagement 'problem' and corresponding solutions. These 'problems' lie on a continuum of complexity in terms of the challenges they present to primary care. Reasons for non-engagement are congruent with the concept of 'candidacy' but point to ways in which it can be expanded.
Conclusions
The paper draws conclusions about the role of outreach in contributing to the implementation of inequalities focused primary prevention and identifies further research needed in the theoretical development of both outreach as an approach and candidacy as a conceptual framework.
doi:10.1186/1472-6963-11-350
PMCID: PMC3266651  PMID: 22204393
18.  Exploring public perspectives on e‐health: findings from two citizen juries 
Abstract
Background  Interest and investment in e‐health continue to grow world‐wide, but there remains relatively little engagement with the public on this subject, despite calls for more public involvement in health‐care planning.
Design  This study used two modified citizen juries to explore barriers and facilitators to e‐health implementation and the priorities for future e‐health research from the perspective of health service users and lay representatives. Citizen juries bring together a group of people to deliberate over a specific issue. They are given information and invited to ‘cross‐examine’ witnesses during the process.
Results  Jurors were very keen for lay views to be included in e‐health development and embraced the citizen jury approach. They agreed unanimously that e‐health should be developed and thought it was in many ways inevitable. Although there was much enthusiasm for a health‐care system which offered e‐health as an option, there was as much concern about what it might mean for patients if implemented inappropriately. E‐health was preferred as an enhancement rather than substitute for, existing services. Lack of universal access was seen as a potential barrier to implementation but problems such as lack of computer literacy were seen as a temporary issue. Participants emphasized that e‐health research needed to demonstrate both clinical and economic benefits.
Conclusion  There was broad support from the citizen juries for the development of e‐health, although participants stressed that e‐health should enhance, rather than substitute, face‐to‐face services. One‐day citizen juries proved a practical method of public engagement on this subject.
doi:10.1111/j.1369-7625.2010.00637.x
PMCID: PMC5060589  PMID: 21029283
citizen juries; e‐health; lay participation
19.  Why is it difficult to implement e-health initiatives? A qualitative study 
Background
The use of information and communication technologies in healthcare is seen as essential for high quality and cost-effective healthcare. However, implementation of e-health initiatives has often been problematic, with many failing to demonstrate predicted benefits. This study aimed to explore and understand the experiences of implementers -- the senior managers and other staff charged with implementing e-health initiatives and their assessment of factors which promote or inhibit the successful implementation, embedding, and integration of e-health initiatives.
Methods
We used a case study methodology, using semi-structured interviews with implementers for data collection. Case studies were selected to provide a range of healthcare contexts (primary, secondary, community care), e-health initiatives, and degrees of normalization. The initiatives studied were Picture Archiving and Communication System (PACS) in secondary care, a Community Nurse Information System (CNIS) in community care, and Choose and Book (C&B) across the primary-secondary care interface. Implementers were selected to provide a range of seniority, including chief executive officers, middle managers, and staff with 'on the ground' experience. Interview data were analyzed using a framework derived from Normalization Process Theory (NPT).
Results
Twenty-three interviews were completed across the three case studies. There were wide differences in experiences of implementation and embedding across these case studies; these differences were well explained by collective action components of NPT. New technology was most likely to 'normalize' where implementers perceived that it had a positive impact on interactions between professionals and patients and between different professional groups, and fit well with the organisational goals and skill sets of existing staff. However, where implementers perceived problems in one or more of these areas, they also perceived a lower level of normalization.
Conclusions
Implementers had rich understandings of barriers and facilitators to successful implementation of e-health initiatives, and their views should continue to be sought in future research. NPT can be used to explain observed variations in implementation processes, and may be useful in drawing planners' attention to potential problems with a view to addressing them during implementation planning.
doi:10.1186/1748-5908-6-6
PMCID: PMC3038974  PMID: 21244714
20.  Normalisation process theory: a framework for developing, evaluating and implementing complex interventions 
BMC Medicine  2010;8:63.
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.
doi:10.1186/1741-7015-8-63
PMCID: PMC2978112  PMID: 20961442
21.  Practice nurses' workload, career intentions and the impact of professional isolation: A cross-sectional survey 
BMC Nursing  2010;9:2.
Background
Practice nurses have a key role within UK general practice, especially since the 2004 GMS contract. This study aimed to describe that role, identify how professionally supported they felt and their career intentions. An additional aim was to explore whether they felt isolated and identify contributory factors.
Methods
A cross-sectional questionnaire survey in one large urban Scottish Health Board, targeted all practice nurses (n = 329). Domains included demographics, workload, training and professional support. Following univariate descriptive statistics, associations between categorical variables were tested using the chi-square test or chi-square test for trend; associations between dichotomous variables were tested using Fisher's Exact test. Variables significantly associated with isolation were entered into a binary logistic regression model using backwards elimination.
Results
There were 200 responses (61.0% response rate). Most respondents were aged 40 or over and were practice nurses for a median of 10 years. Commonest clinical activities were coronary heart disease management, cervical cytology, diabetes and the management of chronic obstructive pulmonary disease. Although most had a Personal Development Plan and a recent appraisal, 103 (52.3%) felt isolated at least sometimes; 30 (15.5%) intended leaving practice nursing within 5 years.
Isolated nurses worked in practices with smaller list sizes (p = 0.024) and nursing teams (p = 0.003); were less likely to have someone they could discuss a clinical/professional (p = 0.002) or personal (p < 0.001) problem with; used their training and qualifications less (p < 0.001); had less productive appraisals (p < 0.001); and were less likely to intend staying in practice nursing (p = 0.009). Logistic regression analysis showed that nurses working alone or in teams of two were 6-fold and 3.5-fold more likely to feel isolated. Using qualifications and training to the full, having productive appraisals and planning to remain in practice nursing all mitigated against feeling isolated.
Conclusions
A significant proportion of practice nurses reported feeling isolated, at least some of the time. They were more likely to be in small practices and more likely to be considering leaving practice nursing. Factors contributing to their isolation were generally located within the practice environment. Providing support to these nurses within their practice setting may help alleviate the feelings of isolation, and could reduce the number considering leaving practice nursing.
doi:10.1186/1472-6955-9-2
PMCID: PMC2823612  PMID: 20205777
22.  Asylum seekers' expectations of and trust in general practice: a qualitative study 
Background
The UK has substantial minority populations of short-term and long-term migrants from countries with various types of healthcare systems.
Aim
This study explored how migrants' previous knowledge and experience of health care influences their current expectations of health care in a system relying on clinical generalists performing a gatekeeping role.
Design of study
Two qualitative methods.
Setting
Glasgow, UK.
Method
Focus groups or semi-structured interviews were conducted with 52 asylum seekers. Analyses identified several areas where previous experience affected current expectations. An overview of health systems in each country of origin was established by combining responders' accounts with World Health Organization statistics.
Results
Asylum seekers had previous experience of a diverse range of healthcare systems, most of which were characterised by a lack of GPs and direct access to hospital-based specialists. For some responders, war or internal conflict resulted in a complete breakdown of healthcare systems. Responders' accounts also highlighted the difficulties that marginalised groups had in accessing health care. Although asylum seekers were generally pleased with the care they received from the NHS, there were areas where they experienced difficulties: confidence in their GP and access to hospital-based specialists and medication. These difficulties encountered might be explained by previous experience.
Conclusion
GPs and other healthcare professionals need to be aware that experience of different systems of care can have an impact on individuals' expectations in a GPled system. If these are not acknowledged and addressed, a lack of confidence and trust in the GP may undermine the effectiveness of the clinical consultation.
doi:10.3399/bjgp08X376104
PMCID: PMC2593560  PMID: 19068152
asylum seekers; general practice; health care needs; trust
23.  Impact of the 2004 GMS contract on practice nurses: 
ABSTRACT
Background
The new GMS contract has led to practice nurses playing an important role in the delivery of the Quality and Outcomes Framework (QOF).
Aim
This study investigated how practice nurses perceive the changes in their work since the contract's inception.
Design of study
A qualitative approach, sampling practice nurses from practices in areas of high and low deprivation, with a range of QOF scores.
Setting
Glasgow, UK.
Method
Individual interviews were conducted, audiotaped, transcribed, and analysed using a thematic approach.
Results
Three themes emerged: roles and incentives, workload, and patient care. Practice nurses were positive about the development of their professional role since the introduction of the new GMS contract but had mixed views about whether their status had changed. Views on incentives (largely related to financial rewards) also varied, but most felt under-rewarded, irrespective of practice QOF achievement. All reported a substantial increase in workload, related to incentivised QOF domains with greater ‘box ticking’ and data entry, and less time to spend with patients. Although the structure created by the new contract was generally welcomed, many were unconvinced that it improved patient care and felt other important areas of care were neglected. Concern was also expressed about a negative effect of the QOF on holistic care, including ethical concerns and detrimental effects on the patient–nurse relationship, which were regarded as a core value.
Conclusions
The new GMS contract has given practice nurses increased responsibility. However, discontent about how financial gains are distributed and negative impacts on core values may lead to detrimental long-term effects on motivation and morale.
doi:10.3399/bjgp08X342183
PMCID: PMC2553531  PMID: 18826783
GMS contract; incentives; practice nurses; primary health care
24.  Practice postcode versus patient population: a comparison of data sources in England and Scotland 
Background
Health professionals, policy-makers and researchers need to be able to explore potential associations between prevalence rates and quality of care with a range of possible determinants including socio-economic deprivation and morbidity levels to determine the impact of commissioning and service delivery. In the UK, data in England are only available nationally at practice postcode level. In Scotland, such data are available based on an aggregate of the practices population's postcodes. The use of data assigned to the practice postcode may underestimate the association between ill health and income deprivation. Here, we report on the impact of using data assigned to the practice population by comparing analyses using English and Scottish data.
Results
Income deprivation based on data assigned to the practice postcode under-estimated deprivation compared to using income deprivation data assigned to the practice population for the five least deprived deciles, and over-estimated deprivation for the five most deprived deciles. The biggest differences were found for the most deprived decile. A similar trend was found for limiting long-term illness (LLTI). Differences between the QOF prevalence rates of the least and most deprived deciles using practice postcode data were similar (0.2% points or less) in England and Scotland for 8 out of 10 clinical domains. Using practice population assigned deprivation, differences in the prevalence rate between the least and most deprived deciles increase for all clinical domains. A similar trend was again found for LLTI. Using practice population assigned deprivation, differences for population achievement increase for all CHD quality indicators with the exception of beta-blockers (CHD10). With practice postcode assigned deprivation, significant differences between the least and most deprived deciles were found for 2 out 8 indicators, compared to 5 using practice population assigned deprivation. For LLTI differences between the lowest and most deprived deciles increased for all indicators when ill health assigned to the practice population was used.
Conclusion
We have found, through comparing deprivation and ill health data assigned to either the practice postcode or the practice population postcode in Scotland, that analyses based on practice postcode assigned data under-estimated the relationship between deprivation and ill health for both prevalence and quality care. Given the importance of understanding the effect of deprivation and ill health on a range of determinants related to health care, policy makers should ensure that practice population data are available and used at national level in England and elsewhere where possible.
doi:10.1186/1476-072X-7-37
PMCID: PMC2490685  PMID: 18631388
25.  The effect of attitude to risk on decisions made by nurses using computerised decision support software in telephone clinical assessment: an observational study 
Background
There is variation in the decisions made by telephone assessment nurses using computerised decision support software (CDSS). Variation in nurses' attitudes to risk has been identified as a possible explanatory factor. This study was undertaken to explore the effect of nurses' attitudes to risk on the decisions they make when using CDSS. The setting was NHS 24 which is a nationwide telephone assessment service in Scotland in which nurses assess health problems, mainly on behalf of out-of-hours general practice, and triage calls to self care, a service at a later date, or immediate contact with a service.
Methods
All NHS 24 nurses were asked to complete a questionnaire about their background and attitudes to risk. Routine data on the decisions made by these nurses was obtained for a six month period in 2005. Multilevel modelling was used to measure the effect of nurses' risk attitudes on the proportion of calls they sent to self care rather than to services.
Results
The response rate to the questionnaire was 57% (265/464). 231,112 calls were matched to 211 of these nurses. 16% (36,342/231,112) of calls were sent to self care, varying three fold between the top and bottom deciles of nurses. Fifteen risk attitude variables were tested, including items on attitudes to risk in clinical decision-making. Attitudes to risk varied greatly between nurses, for example 27% (71/262) of nurses strongly agreed that an NHS 24 nurse "must not take any risks with physical illness" while 17% (45/262) disagreed. After case-mix adjustment, there was some evidence that nurses' attitudes to risk affected decisions but this was inconsistent and unconvincing.
Conclusion
Much of the variation in decision-making by nurses using CDSS remained unexplained. There was no convincing evidence that nurses' attitudes to risk affected the decisions made. This may have been due to the limitations of the instrument used to measure risk attitude.
doi:10.1186/1472-6947-7-39
PMCID: PMC2238735  PMID: 18047658

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