The impact of public involvement in health research: what are we measuring? Why are we measuring it? Should we stop measuring it?

As public involvement in the design, conduct and dissemination of health research has become an expected norm and firmly enshrined in policy, interest in measuring its impact has also grown. Despite a drive to assess the impact of public involvement, and a growing body of studies attempting to do just this, a number of questions have been largely ignored. This commentary addresses these omissions: What is the impact of all this focus on measuring impact? How is the language of impact shaping the debate about, and the practice of, public involvement in health research? And how have shifting conceptualisations of public involvement in health research shaped, and been shaped by, the way we think about and measure impact? We argue that the focus on impact risks distorting how public involvement in health research is conceptualised and practised, blinding us to possible negative impacts. We call for a critical research agenda for public involvement that [a] considers public involvement not as an instrumental intervention but a social practice of dialogue and learning between researchers and the public; [b] explores how power relations play out in the context of public involvement in health research, what empowerment means and whose interests are served by it, and [c] asks questions about possible harms as well as benefits of public involvement, and whether the language of impact is helpful or not.

The role of qualitative research in adding value to a randomised controlled trial: lessons from a pilot study of a guided e-learning intervention for managers to improve employee wellbeing and reduce sickness absence.

BACKGROUND: Despite the growing popularity of mixed-methods studies and considerable emphasis on the potential value of qualitative research to the trial endeavour, there remains a dearth of published studies reporting on actual contribution. This paper presents a critically reflective account of our experience of the actual value of undertaking qualitative research alongside a pilot cluster randomised controlled trial of a guided e-learning intervention for managers in an NHS Mental Health Trust to improve employee wellbeing and reduce sickness absence. For the qualitative study we undertook 36 in-depth interviews with key informants, managers and employees. We observed and took in-depth field notes of 10 meetings involving managers and employees at the Trust, and the two qualitative researchers acted as participant observers at steering committee and monthly research team meetings. We adopted a narrative methodological orientation alongside a thematic approach to data analysis, eliciting a rich account of the complexities of managing stress at work. RESULTS: We identified two key overarching roles played by the qualitative research: 'problematising' and 'contextualising'. Specifically, the qualitative data revealed and challenged assumptions embedded in the trial about the nature of the learning process, and exposed the slippery and contested nature of abstracted variables, on which a trial depends. The qualitative data challenged the trial's logic model, and provided a rich understanding of the context within which the trial and intervention took place. CONCLUSIONS: While acknowledging the ever-present tension in mixed-methods research between the requirements of quantitative research to represent the social world as abstracted variables, and the goal of qualitative research to explore and document the complexity of social phenomena, we adopted a pragmatic position that enabled us to engage with this tension in a productive and partially integrative way. Our critically reflective account of the praxis of integration illuminated opportunities and challenges for maximising the value of qualitative research to a trial. This paper sets out tangible illustrative lessons for other mixed-methods researchers endeavouring to get the most from qualitative research. TRIAL REGISTRATION: This study is registered as ISRCTN58661009 . Registration was submitted on 22 April 2013 and completed on 17 June 2013.

Pilot study of a cluster randomised trial of a guided e-learning health promotion intervention for managers based on management standards for the improvement of employee well-being and reduction of sickness absence: GEM Study.

OBJECTIVES: To investigate the feasibility of recruitment, adherence and likely effectiveness of an e-learning intervention for managers to improve employees' well-being and reduce sickness absence. METHODS: The GEM Study (guided e-learning for managers) was a mixed methods pilot cluster randomised trial. Employees were recruited from four mental health services prior to randomising three services to the intervention and one to no-intervention control. Intervention managers received a facilitated e-learning programme on work-related stress. Main outcomes were Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), 12-item GHQ and sickness absence <21 days from human resources. 35 in-depth interviews were undertaken with key informants, managers and employees, and additional observational data collected. RESULTS: 424 of 649 (65%) employees approached consented, of whom 350 provided WEMWBS at baseline and 284 at follow-up; 41 managers out of 49 were recruited from the three intervention clusters and 21 adhered to the intervention. WEMWBS scores fell from 50.4-49.0 in the control (n=59) and 51.0-49.9 in the intervention (n=225), giving an intervention effect of 0.5 (95% CI -3.2 to 4.2). 120/225 intervention employees had a manager who was adherent to the intervention. HR data on sickness absence (n=393) showed no evidence of effect. There were no effects on GHQ score or work characteristics. Online quiz knowledge scores increased across the study in adherent managers. Qualitative data provided a rich picture of the context within which the intervention took place and managers' and employees' experiences of it. CONCLUSIONS: A small benefit from the intervention on well-being was explained by the mixed methods approach, implicating a low intervention uptake by managers and suggesting that education alone may be insufficient. A full trial of the guided e-learning intervention and economic evaluation is feasible. Future research should include more active encouragement of manager motivation, reflection and behaviour change. TRIAL REGISTRATION NUMBER: ISRCTN58661009.

'Cosmetic boob jobs' or evidence-based breast surgery: an interpretive policy analysis of the rationing of 'low value' treatments in the English National Health Service.

BACKGROUND: In England the National Health Service (NHS) is not allowed to impose 'blanket bans' on treatments, but local commissioners produce lists of 'low value' procedures that they will normally not fund. Breast surgery is one example. However, evidence suggests that some breast surgery is clinically effective, with significant health gain. National guidelines indicate the circumstances under which breast surgery should be made available on the NHS, but there is widespread variation in their implementation.The purpose of this study was to explore the work practices of 'individual funding request' (IFR) panels, as they considered 'one-off' funding requests for breast surgery; examine how the notion of 'value' is dialogically constructed, and how decisions about who is deserving of NHS funding and who is not are accomplished in practice. METHODS: We undertook ethnographic exploration of three IFR panels. We extracted all (22) breast surgery cases considered by these panels from our data set and progressively focused on three case discussions, one from each panel, covering the three main breast procedures.We undertook a microanalysis of the talk and texts arising from these cases, within a conceptual framework of interpretive policy analysis. RESULTS: Through an exploration of the symbolic artefacts (language, objects and acts) that are significant carriers of policy meaning, we identified the ways in which IFR panels create their own 'interpretive communities', within which deliberations about the funding of breast surgery are differently framed, and local decisions come to be justified. In particular, we demonstrated how each decision was contingent on [a] the evaluative accent given to certain words, [b] the work that documentary objects achieve in foregrounding particular concerns, and [c] the act of categorising. Meaning was constructed dialogically through local interaction and broader socio-cultural discourses about breasts and 'cosmetic' surgery. CONCLUSION: Despite the appeal of calls to tackle 'unwarranted variation' in access to low priority treatments by ensuring uniformity of local guidelines and policies, our findings suggest that ultimately, given the contingent nature of practice, this is likely to remain an illusory policy goal. Our findings challenge the scientistic thinking underpinning mainstream health policy discourse.

Evaluating social outcomes of HIV/AIDS interventions: a critical assessment of contemporary indicator frameworks.

INTRODUCTION: Contemporary HIV-related theory and policy emphasize the importance of addressing the social drivers of HIV risk and vulnerability for a long-term response. Consequently, increasing attention is being given to social and structural interventions, and to social outcomes of HIV interventions. Appropriate indicators for social outcomes are needed in order to institutionalize the commitment to addressing social outcomes. This paper critically assesses the current state of social indicators within international HIV/AIDS monitoring and evaluation frameworks. METHODS: We analyzed the indicator frameworks of six international organizations involved in efforts to improve and synchronize the monitoring and evaluation of the HIV/AIDS response. Our analysis classifies the 328 unique indicators according to what they measure and assesses the degree to which they offer comprehensive measurement across three dimensions: domains of the social context, levels of change and organizational capacity. RESULTS AND DISCUSSION: The majority of indicators focus on individual-level (clinical and behavioural) interventions and outcomes, neglecting structural interventions, community interventions and social outcomes (e.g. stigma reduction; community capacity building; policy-maker sensitization). The main tool used to address social aspects of HIV/AIDS is the disaggregation of data by social group. This raises three main limitations. Indicator frameworks do not provide comprehensive coverage of the diverse social drivers of the epidemic, particularly neglecting criminalization, stigma, discrimination and gender norms. There is a dearth of indicators for evaluating the social impacts of HIV interventions. Indicators of organizational capacity focus on capacity to effectively deliver and manage clinical services, neglecting capacity to respond appropriately and sustainably to complex social contexts. CONCLUSIONS: Current indicator frameworks cannot adequately assess the social outcomes of HIV interventions. This limits knowledge about social drivers and inhibits the institutionalization of social approaches within the HIV/AIDS response. We conclude that indicator frameworks should expand to offer a more comprehensive range of social indicators for monitoring and evaluation and to include indicators of organizational capacity to tackle social drivers. While such expansion poses challenges for standardization and coordination, we argue that the complexity of interventions producing social outcomes necessitates capacity for flexibility and local tailoring in monitoring and evaluation.

'Timely' diagnosis of dementia: what does it mean? A narrative analysis of GPs' accounts.

OBJECTIVE: To explore general practitioners' (GP) perspectives on the meaning of 'timeliness' in dementia diagnosis. DESIGN: Narrative interview study. SETTING: UK academic department of primary care. PARTICIPANTS: Seven practising GPs with experience of conveying a diagnosis of dementia. METHODS: GPs' narrative commentaries of encounters with patients with suspected dementia were audio-recorded and transcribed resulting in 51 pages of text (26 757words). A detailed narrative analysis of doctors' accounts was conducted. RESULTS: Diagnosis of dementia is a complex medical and social practice. Clinicians attend to multiple competing priorities while providing individually tailored patient care, against a background of shifting political and institutional concerns. Interviewees drew on a range of explanations about the nature of generalism to legitimise their claims about whether and how they made a diagnosis, constructing their accounts of what constituted 'timeliness'. Three interlinked analytical themes were identified: (1) diagnosis as a collective, cumulative, contingent process; (2) taking care to ensure that diagnosis-if reached at all-is opportune; (3) diagnosis of dementia as constitutive or consequential, but also a diagnosis whose consequences are unpredictable. CONCLUSIONS: Timeliness in the diagnosis of dementia involves balancing a range of judgements and is not experienced in terms of simple chronological notions of time. Reluctance or failure to make a diagnosis on a particular occasion does not necessarily point to GPs' lack of awareness of current policies, or to a set of training needs, but commonly reflects this range of nuanced balancing judgements, often negotiated with patients and their families with detailed attention to a particular context. In the case of dementia, the taken-for-granted benefits of early diagnosis cannot be assumed, but need to be 'worked through' on an individual case-by-case basis. GPs tend to value 'rightness' of time over concerns about 'early' diagnosis.

Thinking about think tanks in health care: a call for a new research agenda.

Little sociological attention has been given to the role of think tanks in health policy and planning. Existing work in political science and public administration tends to define and categorise think tanks and situate them as a disinterested source of policy expertise. Despite the increasingly visible presence of think tanks in the world of health care, such work has done little to reveal how they operate, by whom and to what ends. Our article seeks to redress this firstly by examining why they have remained relatively hidden in academic analyses and secondly by advocating an interpretive approach that incorporates think tanks within the wider landscape of health policy and planning. In contrast to most existing literature, an interpretive approach acknowledges that much of the messy business of healthcare policy and planning remains hidden from view and that much can be gleaned by examining the range of organisations, actors, coalitions, everyday activities, artefacts and interactions that make up the think tank stage and that work together to shape health policy and planning. Given the paucity of research in this area, we urge the medical sociology community to open the field to further academic scrutiny.

Being 'rational' and being 'human': How National Health Service rationing decisions are constructed as rational by resource allocation panels.

The English National Health Service Constitution states that patients have the right to expect all decisions about access to medicines and treatments to be made 'rationally'. Rationality in health care can be framed as instrumental, institutional or practical. In this article, we present a case example from an ethnographic study of the work of 'Individual Funding Request' panels to explore how rationality is enacted and accounted for in deliberations about the rationing of health care in the National Health Service. Our rhetorical analysis highlights how an embodied, practical rationality emerges as a significant aspect of rationality in practice, but at the same time has a problematic status in formal accounts of decision-making. We suggest that being both 'human' and 'rational' is a 'delicate balance' and creates a dilemma for Individual Funding Request panels. Aristotle's notion of phronesis provides a useful lens for theorising our observation of panel deliberations, and we argue for greater attention to the value of narrative ethics in helping us understand the challenges faced by resource allocators.

Affordability as a discursive accomplishment in a changing National Health Service.

Health systems worldwide face the challenges of rationing. The English National Health Service (NHS) was founded on three core principles: universality, comprehensiveness, and free at the point of delivery. Yet patients are increasingly hearing that some treatments are unaffordable on the NHS. We considered affordability as a social accomplishment and sought to explore how those charged with allocating NHS resources achieved this in practice. We undertook a linguistic ethnography to examine the work practices of resource allocation committees in three Primary Care Trusts (PCTs) in England between 2005 and 2012, specifically deliberations over 'individual funding requests' (IFRs)--requests by patients and their doctors for the PCT to support a treatment not routinely funded. We collected and analysed a diverse dataset comprising policy documents, legal judgements, audio recordings, ethnographic field notes and emails from PCT committee meetings, interviews and a focus group with committee members. We found that the fundamental values of universality and comprehensiveness strongly influenced the culture of these NHS organisations, and that in this context, accomplishing affordability was not easy. Four discursive practices served to confer legitimacy on affordability as a guiding value of NHS health care: (1) categorising certain treatments as only eligible for NHS funding if patients could prove 'exceptional' circumstances; (2) representing resource allocation decisions as being not (primarily) about money; (3) indexical labelling of affordability as an ethical principle, and (4) recontextualising legal judgements supporting refusal of NHS treatment on affordability grounds as 'rational'. The overall effect of these discursive practices was that denying treatment to patients became reasonable and rational for an organisation even while it continued to espouse traditional NHS values. We conclude that deliberations about the funding of treatments at the margins of NHS care have powerful consequences both for patients and for redrawing the ideological landscape of NHS care.

Why national eHealth programs need dead philosophers: Wittgensteinian reflections on policymakers' reluctance to learn from history.

CONTEXT: Policymakers seeking to introduce expensive national eHealth programs would be advised to study lessons from elsewhere. But these lessons are unclear, partly because a paradigm war (controlled experiment versus interpretive case study) is raging. England's $20.6 billion National Programme for Information Technology (NPfIT) ran from 2003 to 2010, but its overall success was limited. Although case study evaluations were published, policymakers appeared to overlook many of their recommendations and persisted with some of the NPfIT's most criticized components and implementation methods. METHODS: In this reflective analysis, illustrated by a case fragment from the NPfIT, we apply ideas from Ludwig Wittgenstein's postanalytic philosophy to justify the place of the "n of 1" case study and consider why those in charge of national eHealth programs appear reluctant to learn from such studies. FINDINGS: National eHealth programs unfold as they do partly because no one fully understands what is going on. They fail when this lack of understanding becomes critical to the programs' mission. Detailed analyses of the fortunes of individual programs, articulated in such a way as to illuminate the contextualized talk and action ("language games") of multiple stakeholders, offer unique and important insights. Such accounts, portrayals rather than models, deliver neither statistical generalization (as with experiments) nor theoretical generalization (as with multisite case comparisons or realist evaluations). But they do provide the facility for heuristic generalization (i.e., to achieve a clearer understanding of what is going on), thereby enabling more productive debate about eHealth programs' complex, interdependent social practices. A national eHealth program is best conceptualized not as a blueprint and implementation plan for a state-of-the-art technical system but as a series of overlapping, conflicting, and mutually misunderstood language games that combine to produce a situation of ambiguity, paradox, incompleteness, and confusion. But going beyond technical "solutions" and engaging with these language games would clash with the bounded rationality that policymakers typically employ to make their eHealth programs manageable. This may explain their limited and contained response to the nuanced messages of in-depth case study reports. CONCLUSION: The complexity of contemporary health care, combined with the multiple stakeholders in large technology initiatives, means that national eHealth programs require considerably more thinking through than has sometimes occurred. We need fewer grand plans and more learning communities. The onus, therefore, is on academics to develop ways of drawing judiciously on the richness of case studies to inform and influence eHealth policy, which necessarily occurs in a simplified decision environment.

Receptionist input to quality and safety in repeat prescribing in UK general practice: ethnographic case study.

OBJECTIVE: To describe, explore, and compare organisational routines for repeat prescribing in general practice to identify contributors and barriers to safety and quality. DESIGN: Ethnographic case study. SETTING: Four urban UK general practices with diverse organisational characteristics using electronic patient records that supported semi-automation of repeat prescribing. PARTICIPANTS: 395 hours of ethnographic observation of staff (25 doctors, 16 nurses, 4 healthcare assistants, 6 managers, and 56 reception or administrative staff), and 28 documents and other artefacts relating to repeat prescribing locally and nationally. MAIN OUTCOME MEASURES: Potential threats to patient safety and characteristics of good practice. METHODS: Observation of how doctors, receptionists, and other administrative staff contributed to, and collaborated on, the repeat prescribing routine. Analysis included mapping prescribing routines, building a rich description of organisational practices, and drawing these together through narrative synthesis. This was informed by a sociological model of how organisational routines shape and are shaped by information and communications technologies. Results Repeat prescribing was a complex, technology-supported social practice requiring collaboration between clinical and administrative staff, with important implications for patient safety. More than half of requests for repeat prescriptions were classed as "exceptions" by receptionists (most commonly because the drug, dose, or timing differed from what was on the electronic repeat list). They managed these exceptions by making situated judgments that enabled them (sometimes but not always) to bridge the gap between the idealised assumptions about tasks, roles, and interactions that were built into the electronic patient record and formal protocols, and the actual repeat prescribing routine as it played out in practice. This work was creative and demanded both explicit and tacit knowledge. Clinicians were often unaware of this input and it did not feature in policy documents or previous research. Yet it was sometimes critical to getting the job done and contributed in subtle ways to safeguarding patients. Conclusion Receptionists and administrative staff make important "hidden" contributions to quality and safety in repeat prescribing in general practice, regarding themselves accountable to patients for these contributions. Studying technology-supported work routines that seem mundane, standardised, and automated, but which in reality require a high degree of local tailoring and judgment from frontline staff, opens up a new agenda for the study of patient safety.

Ethnographic study of ICT-supported collaborative work routines in general practice.

BACKGROUND: Health informatics research has traditionally been dominated by experimental and quasi-experimental designs. An emerging area of study in organisational sociology is routinisation (how collaborative work practices become business-as-usual). There is growing interest in the use of ethnography and other in-depth qualitative approaches to explore how collaborative work routines are enacted and develop over time, and how electronic patient records (EPRs) are used to support collaborative work practices within organisations. METHODS/DESIGN: Following Feldman and Pentland, we will use 'the organisational routine' as our unit of analysis. In a sample of four UK general practices, we will collect narratives, ethnographic observations, multi-modal (video and screen capture) data, documents and other artefacts, and analyse these to map and compare the different understandings and enactments of three common routines (repeat prescribing, coding and summarising, and chronic disease surveillance) which span clinical and administrative spaces and which, though 'mundane', have an important bearing on quality and safety of care. In a detailed qualitative analysis informed by sociological theory, we aim to generate insights about how complex collaborative work is achieved through the process of routinisation in healthcare organisations. DISCUSSION: Our study offers the potential not only to identify potential quality failures (poor performance, errors, failures of coordination) in collaborative work routines but also to reveal the hidden work and workarounds by front-line staff which bridge the model-reality gap in EPR technologies and via which "automated" safety features have an impact in practice.

Adoption, non-adoption, and abandonment of a personal electronic health record: case study of HealthSpace.

OBJECTIVE: To evaluate the policy making process, implementation by NHS organisations, and patients' and carers' experiences of efforts to introduce an internet accessible personal electronic health record (HealthSpace) in a public sector healthcare system. DESIGN: Mixed method, multilevel case study. SETTING: English National Health Service; the basic HealthSpace technology (available throughout England) and the advanced version (available in a few localities where this option had been introduced) were considered. MAIN OUTCOME MEASURES: National statistics on invitations sent, HealthSpace accounts created, and interviews and ethnographic observation of patients and carers. Data analysis was informed by a socio-technical approach which considered macro and micro influences on both adoption and non-adoption of innovations, and by the principles of critical discourse analysis. PARTICIPANTS: 56 patients and carers (of whom 21 opened a basic HealthSpace account, 20 had diabetes but were not initially using HealthSpace, and 15 used advanced HealthSpace accounts to exchange messages with their general practitioner), 3000 pages of documents (policies, strategies, business plans, minutes of meetings, correspondence), observational field notes, and 160 interviews with policy makers, project managers, and clinical staff. RESULTS: Between 2007 and October 2010, 172 950 people opened a basic HealthSpace account. 2913 (0.13% of those invited) opened an advanced account, compared with 5-10% of the population anticipated in the original business case. Overall, patients perceived HealthSpace as neither useful nor easy to use and its functionality aligned poorly with their expectations and self management practices. Those who used email-style messaging were positive about its benefits, but enthusiasm beyond three early adopter clinicians was low, and fewer than 100 of 30 000 patients expressed interest. Policy makers' hopes that "deploying" HealthSpace would lead to empowered patients, personalised care, lower NHS costs, better data quality, and improved health literacy were not realised over the three year evaluation period. CONCLUSION: Unless personal electronic health records align closely with people's attitudes, self management practices, identified information needs, and the wider care package (including organisational routines and incentive structures for clinicians), the risk that they will be abandoned or not adopted at all is substantial. Conceptualising such records dynamically (as components of a socio-technical network) rather than statically (as containers for data) and employing user centred design techniques might improve their chances of adoption and use. The findings raise questions about how eHealth programmes in England are developed and approved at policy level.

Adoption and non-adoption of a shared electronic summary record in England: a mixed-method case study.

OBJECTIVE: To evaluate a national programme to develop and implement centrally stored electronic summaries of patients' medical records. DESIGN: Mixed-method, multilevel case study. SETTING: English National Health Service 2007-10. The summary care record (SCR) was introduced as part of the National Programme for Information Technology. This evaluation of the SCR considered it in the context of national policy and its frontline implementation and use in three districts. Participants and methods Quantitative data (cumulative records created nationally plus a dataset of 416 325 encounters in participating primary care out-of-hours and walk-in centres) were analysed statistically. Qualitative data (140 interviews including policy makers, managers, clinicians, and software suppliers; 2000 pages of ethnographic field notes including observation of 214 clinical consultations; and 3000 pages of documents) were analysed thematically and interpretively. RESULTS: Creating individual SCRs and supporting their adoption and use was a complex, technically challenging, and labour intensive process that occurred more slowly than planned. By early 2010, 1.5 million such records had been created. In participating primary care out-of-hours and walk-in centres, an SCR was accessed in 4% of all encounters and in 21% of encounters where one was available; these figures were rising in some but not all sites. The main determinant of SCR access was the identity of the clinician: individual clinicians accessed available SCRs between 0 and 84% of the time. When accessed, an SCR seemed to support better quality care and increase clinician confidence in some encounters. There was no direct evidence of improved safety, but findings were consistent with a rare but important positive impact on preventing medication errors. SCRs sometimes contained incomplete or inaccurate data, but clinicians drew judiciously on these data along with other sources. SCR use was not associated with shorter consultations or reduction in onward referral. Successful introduction of SCRs depended on interaction between multiple stakeholders from different worlds (clinical, political, technical, commercial) with different values, priorities, and ways of working. The programme's fortunes seemed to turn on the ability of change agents to bridge these different institutional worlds, align their conflicting logics, and mobilise implementation effort. CONCLUSIONS: Benefits of centrally stored electronic summary records seem more subtle and contingent than many stakeholders anticipated, and clinicians may not access them. Complex interdependencies, inherent tensions, and high implementation workload should be expected when they are introduced on a national scale.

Evidence-based policymaking: a critique.

The idea that policy should be based on best research evidence might appear to be self-evident. But a closer analysis reveals a number of problems and paradoxes inherent in the concept of "evidence-based policymaking." The current conflict over evidence-based policymaking parallels a long-standing "paradigm war" in social research between positivist, interpretivist, and critical approaches. This article draws from this debate in order to inform the discussions over the appropriateness of evidence- based policymaking and the related question of what is the nature of policymaking. The positivist, empiricist worldview that underpins the theory and practice of evidence-based medicine (EBM) fails to address key elements of the policymaking process. In particular, a narrowly "evidence-based" framing of policymaking is inherently unable to explore the complex, context-dependent, and value-laden way in which competing options are negotiated by individuals and interest groups. Sociolinguistic tools such as argumentation theory offer opportunities for developing richer theories about how policymaking happens. Such tools also have potential practical application in the policymaking process: by enhancing participants' awareness of their own values and those of others, the quality of the collective deliberation that lies at the heart of policymaking may itself improve.

Introduction of shared electronic records: multi-site case study using diffusion of innovation theory.

OBJECTIVE: To explore the introduction of a centrally stored, shared electronic patient record (the summary care record (SCR)) in England and draw wider lessons about the implementation of large scale information technology projects in health care. DESIGN: Multi-site, mixed method case study applying utilisation focused evaluation. SETTING: Four early adopter sites for the SCR in England-three in urban areas of relative socioeconomic deprivation and the fourth in a relatively affluent rural area. Data sources and analysis Data included 250 staff interviews, 1500 hours of ethnographic observation, interviews and focus groups with 170 patients and carers, 2500 pages of correspondence and documentary evidence, and incorporation of relevant surveys and statistics produced by others. These were analysed by using a thematic approach drawing on (and extending) a theoretical model of complex change developed in a previous systematic review. Main findings The mixed fortunes of the SCR programme in its first year were largely explained by eight interacting influences. The first was the SCR's material properties (especially technical immaturity and lack of interoperability) and attributes (especially the extent to which potential adopters believed the benefits outweighed the risks). The second was adopters' concerns (especially about workload and the ethicality of sharing "confidential" information on an implied consent model). The third influence was interpersonal influence (for example, opinion leaders, champions, facilitators), and the fourth was organisational antecedents for innovation (for example past experience with information technology projects, leadership and management capacity, effective data capture systems, slack resources). The fifth was organisational readiness for the SCR (for example, innovation-system fit, tension for change, power balances between supporters and opponents, baseline data quality). The sixth was the implementation process (including the nature of the change model and the extent to which new routines associated with the SCR aligned with existing organisational routines). The seventh influence was the nature and quality of links between different parts of the system, and the final one was the wider environment (especially the political context of the programme). CONCLUSION: Shared electronic records are not plug-in technologies. They are complex innovations that must be accepted by individual patients and staff and also embedded in organisational and inter-organisational routines. This process is heavily influenced at the micro-level by the material properties of the technology, individuals' attitudes and concerns, and interpersonal influence; at the meso-level by organisational antecedents, readiness, and operational aspects of implementation; and at the macro-level by institutional and socio-political forces. A case study approach and multi-level theoretical analysis can illuminate how contextual factors shape, enable, and constrain new, technology supported models of patient care.