Search

This article presents findings from local government projects to realise the benefits of big data for policy. Through participatory action research with two local statutory authorities in the South West of England, we observed the activities of identifying, integrating and analysing multiple and diverse forms of data, including large administrative datasets, to generate insights on live policy priorities and inform decision-making. We reveal the significance of both data production and policymaking contexts in explaining how big data of this kind can be called upon and enacted in policy processes.

Introduction: Food hypersensitivity (FHS), including food allergy, coeliac disease and food intolerance, is a major public health issue. The Food Standards Agency (FSA), an independent UK Government department working to protect public health and consumers’ wider interests in food, sought to identify research priorities in the area of FHS. Methods: A priority setting exercise was undertaken, using a methodology adapted from the James Lind Alliance—the first such exercise with respect to food hypersensitivity. A UK-wide public consultation was held to identify unanswered research questions. After excluding diagnostics, desensitization treatment and other questions which were out of scope for FSA or where FSA was already commissioning research, 15 indicative questions were identified and prioritized by a range of stakeholders, representing food businesses, patient groups, health care and academia, local authorities and the FSA. Results: 295 responses were received during the public consultation, which were categorized into 70 sub-questions and used to define 15 key evidence uncertainties (‘indicative questions’) for prioritization. Using the JLA prioritization framework, this resulted in 10 priority uncertainties in evidence, from which 16 research questions were developed. These could be summarized under the following 5 themes: communication of allergens both within the food supply chain and then to the end consumer (ensuring trust in allergen communication); the impact of socio-economic factors on consumers with FHS; drivers of severe reactions; mechanism(s) underlying loss of tolerance in FHS; and the risks posed by novel allergens/processing. Discussion: In this first research prioritization exercise for food allergy and FHS, key priorities identified to protect the food-allergic public were strategies to help allergic consumers to make confident food choices, prevention of FHS and increasing understanding of socio-economic impacts. Diagnosis and treatment of FHS

The world of Research Methods is always changing and becoming ever more complex. Now completely up to date with the latest innovations, this book engages with recent controversies to give you the best start with your research. In each chapter you will find: · Key concept boxes to help you stay on track and focus on what’s most important · Real life examples which make the theory easier to understand · Exercises to check you’ve understood the chapter · Questions to help you develop your critical thinking. Also available online are: · Multiple choice questions to test your understanding · Datasets to allow you to practice your skills · A flashcard glossary to help with revision. Offering a complete package to anyone taking a research methods course as part of their degree.

In a context of rapidly increasing urbanisation and deepening global inequalities, slum tourism has thrived. This paper presents a discursive analysis of tourists’ online reviews of two township tours in Cape Town, South Africa. We investigate how, and to what ends, tourists collectively construct townships as places of hope on TripAdvisor; we question how these reviews feed into broader narratives of urban poverty in the global south. We show how tourists draw on both neoliberal and colonial discourses to construct townships as places of hope–vibrant cultural spaces, rich in non-material assets, inhabited by happy, hard-working residents. We show that by producing slums as productive cultural spaces, tourists are able to resist the stigma associated with slum tourism and position themselves as ethical, enlightened and morally superior tourists. We argue that neoliberal and colonial discourses operate together to produce sanitised representations of townships that both obscure inequalities between poor residents and wealthy tourists from the global north and depoliticise issues like poor infrastructure in townships. In discussing the broader implications of the study, we highlight the importance of producing nuanced representations of townships that acknowledge residents’ assets and excellence, while also foregrounding how they live within the oppressive constraints inherent in enduring systems of inequality.

Background: The lateral epicondyle is a common site for chronic tendinosis (i.e. lateral epicondylitis), a condition characterized by overuse and degeneration of a tendon due to repeated microtrauma. This leads to pain and functional limitations. There is a growing interest in non-surgical forms of treatment for this condition including provision of corticosteroid injections and regenerative injection therapy (provision of autologous blood and platelet rich plasma injections). Objective: We compared the effectiveness of corticosteroids with regenerative injection therapy for the treatment of lateral epicondylitis. Methods: We systematically reviewed randomized controlled trials published in English language from 2008 to 2018. Databases used included PEDro, Scopus, PubMed, and CINAHL. Nine articles met our selection criteria. The PEDRo scale scores helped assess study quality. Cochrane risk of bias criteria helped assess bias. We analyzed results focusing on pain and function using meta-analyses. Results: Six out of 9 studies had low risk of bias. There were no short-term (1 and 2 month) differences in pain scores between the corticosteroid and regenerative injection groups. Participants receiving regenerative injections demonstrated greater long-term improvements lasting for a period of ≈2 years. Conclusion: Regenerative injections provision results in greater long–term pain relief and improved function for people with lateral epicondylitis.

One of the main challenges of emergency management lies in communicating risks to the public. On some occasions, risk communicators might seek to increase awareness over emerging risks, while on others the aim might be to avoid escalation of public reactions. Social media accounts offer an opportunity to rapidly distribute critical information and in doing so to mitigate the impact of emergencies by influencing public reactions. This article draws on theories of risk and emergency communication in order to consider the impact of Twitter as a tool for communicating risks to the public. We analyse 10,020 Twitter messages posted by the official accounts of UK local government authorities (councils) in the context of two major emergencies: the heavy snow of December 2010 and the riots of August 2011. Twitter was used in a variety of ways to communicate and manage associated risks including messages to provide official updates, encourage protective behaviour, increase awareness and guide public attention to mitigating actions. We discuss the importance of social media as means of increasing confidence in emergency management institutions.

UK energy policy contains ambitious goals for increased deployment of renewable energy technologies (RETs), but concern remains about the potential of local opposition to obstruct proposed developments. Despite emerging academic consensus that characterizing opposition to RET siting as NIMBYism is problematic, the discourse remains strong in popular debate. This article responds to calls for sociological research on both ascriptions of NIMBYism and the use of deficit models. Through an analysis of interviews with key actors in the renewable energy industry, we explore the ways in which a discourse of NIMBYism is evident in their descriptions of local wind farm opponents. We conceptualize this discourse as embodying an array of deficit models of the public and public knowledge. This is significant not only because developers' constructions of publics inform their modes of engagement with them, but also because they may influence public responses themselves.

In the past decade, growing public concern about novel technologies with uncertain potential long-term impacts on the environment and human health has moved risk policies toward a more precautionary approach. Focusing on mobile telephony, the effects of precautionary information on risk perception were analyzed. A pooled multinational experimental study based on a 5 x 2 x 2 factorial design was conducted in nine countries. The first factor refers to whether or not information on different types of precautionary measures was present, the second factor to the framing of the precautionary information, and the third factor to the order in which cell phones and base stations were rated by the study participants. The data analysis on the country level indicates different effects. The main hypothesis that informing about precautionary measures results in increased risk perceptions found only partial support in the data. The effects are weaker, both in terms of the effect size and the frequency of significant effects, across the various precautionary information formats used in the experiment. Nevertheless, our findings do not support the assumption that informing people about implemented precautionary measures will decrease public concerns.

Against the backdrop of the imperatives for actors within the institutional framework of energy socio-technical systems to engage with the public, the aim of this paper is to consider interdependencies between the principles and practice of engagement and the nature of the imagined publics with whom engagement is being undertaken. Based on an analysis of 19 interviews with actors in the renewable energy industry, the paper explores how publics are imagined in the construction of the rationales, functions and mechanisms for public engagement. Three main themes are identified. First, the perceived necessity of engagement - which is not contingent on public responsiveness. Second, engagement is primarily conceptualised in terms of instrumental motives of providing information and addressing public concern. Third, preferences for engagement mechanisms were often a function of the specific characteristics attributed to imagined publics. Implications of this analysis for future engagement around siting renewable energy technologies are considered.

Syed Ghulam Sarwar Shah,1 Julie Barnett,1 Jasna Kuljis,2 Kate Hone,2 Richard Kaczmarski31Multidisciplinary Assessment of Technology Centre for Healthcare, 2Department of Information Systems and Computing, Brunel University London, Uxbridge, Middlesex, UK; 3Department of Haematology, Hillingdon Hospital, Uxbridge, Middlesex, UKPurpose: To identify factors that determine patients' intentions to use point-of-care medical devices, ie, portable coagulometer devices for self-testing of the international normalized ratio (INR) required for ongoing monitoring of blood-coagulation intensity among patients on long-term oral anticoagulation therapy with vitamin K antagonists, eg, warfarin.Methods: A cross-sectional study that applied the technology-acceptance model through a self-completed questionnaire, which was administered to a convenience sample of 125 outpatients attending outpatient anticoagulation services at a district general hospital in London, UK. Data were analyzed using descriptive statistics, factor analyses, and structural equation modeling.Results: The participants were mainly male (64%) and aged ≥ 71 years (60%). All these patients were attending the hospital outpatient anticoagulation clinic for INR testing; only two patients were currently using INR self-testing, 84% of patients had no knowledge about INR self-testing using a portable coagulometer device, and 96% of patients were never offered the option of the INR self-testing. A significant structural equation model explaining 79% of the variance in patients’ intentions to use INR self-testing was observed. The significant predictors that directly affected patients' intention to use INR self-testing were the perception of technology (β = 0.92, P < 0.001), trust in doctor (β = −0.24, P = 0.028), and affordability (β = 0.15, P = 0.016). In addition, the perception of technology was significantly affected by trust in doctor (&be

Significant ongoing debate exists amongst stakeholders as to the best front-of-pack labelling approach and emerging evidence suggests that the plethora of schemes may cause confusion for the consumer. To gain a better understanding of the relevant psychological phenomena and consumer perspectives surrounding FoP labelling schemes and their optimal development a Multiple Sort Procedure study involving free sorting of a range of nutritional labels presented on cards was performed in four countries (n = 60). The underlying structure of the qualitative data generated was explored using Multiple Scalogram Analysis. Elicitation of categorisations from consumers has the potential to provide a very important perspective in this arena and results demonstrated that the amount of information contained within a nutrition label has high salience for consumers, as does the health utility of the label although a dichotomy exists in the affective evaluation of the labels containing varying degrees of information aggregation. Classification of exiting front-of-pack labelling systems on a proposed dimension of ‘directiveness’ leads to a better understanding of why some schemes may be more effective than others in particular situations or for particular consumers. Based on this research an enhanced hypothetical front-of-pack labelling scheme which combines both directive and non-directive elements is proposed.

While the rhetoric of public engagement is increasingly commonplace within industry, there has been little research that examines how lay knowledge is conceptualized and whether it is really used within companies. Using the chemicals sector as an example, this paper explores how companies conceive of publics and “public knowledge,” and how this relates to modes of engagement/communication with them. Drawing on qualitative empirical research in four companies, we demonstrate that the public for industry are primarily conceived as “consumers” and “neighbours,” having concerns that should be allayed rather than as groups with knowledge meriting engagement. We conclude by highlighting the dissonance between current advocacy of engagement and the discourses and practices prevalent within industry, and highlight the need for more realistic strategies for industry/public engagement.

The main objective of PACHELBEL is the development, trialling and operationalisation of a tool called STAVE, which will be designed to support the work of policy-making for sustainability in real-world settings. The tool will support processes of knowledge brokerage, promoting the appropriate application of existing research findings, and the generation of new knowledge which is focused on specific policy objectives., L'objectiu principal del projecte PACHELBEL és desenvolupar, provar i operacionalitzar un instrument anomenat STAVE (Systematic Tool for Behavioural Assumption Validation and Exploration), que haurà de servir per a donar suport als dissenyadors de polítiques públiques ambientals i per la sostenibilitat. Aquesta eina servirà per gestionar millor els processos de transmissió de coneixement entre el públic i les institucions polítiques, així com per a integrar millor els resultats de les recerques socials en l'elaboració de polítiques públiques i per a generar nou coneixement al respecte.

'The public' are potentially implicated in processes of sociotechnical change as political actors who welcome or resist technology development in general, or in particular places and settings. We argue in this paper that the potential influence of public subjectivities on sociotechnical change is realised not only through moments of active participation and protest, but also through 'the public' being imagined, given agency, and invoked for various purposes by actors in technical industrial and policy networks. As a case study we explore the significance of an imagined and anticipated public subjectivity for the development of renewable energy technologies in the UK. We use interviews with a diversity of industry and policy actors to explore how imaginaries of the public are constructed from first-hand and mediated experience and knowledge, and the influence these imagined public subjectivitics may have on development trajectories and on actor strategics and activities. We show how the shared expectation of an ever present latent but conditional public hostility to renewable energy project development is seen as shaping the material forms of the technologies, their evolving spatiality, and practices of public engagement involved in obtaining project consent. Implications for the actors we are interested in and for broader questions of democratic practice are considered.

This report describes research carried out over two years (2002 – 2004) on relationships between the Environment Agency and special interest groups, a term used here to describe non-governmental non-profit-making groups with a special interest in areas or issues in which the Environment Agency is involved. The report is aimed primarily at staff who work with special interest groups at the local or national level.

The ability of scientists to apply cloning technology to humans has provoked public discussion and media coverage. The present paper reports on a series of studies examining public attitudes to human cloning in the UK, bringing together a range of quantitative and qualitative methods to address this question. These included a nationally representative survey, an experimental vignette study, focus groups and analyses of media coverage. Overall the research presents a complex picture of attitude to and constructions of human cloning. In all of the analyses, therapeutic cloning was viewed more favourably than reproductive cloning. However, while participants in the focus groups were generally negative about both forms of cloning, and this was also reflected in the media analyses, quantitative results showed more positive responses. In the quantitative research, therapeutic cloning was generally accepted when the benefits of such procedures were clear, and although reproductive cloning was less accepted there was still substantial support. Participants in the focus groups only differentiated between therapeutic and reproductive cloning after the issue of therapeutic cloning was explicitly raised; initially they saw cloning as being reproductive cloning and saw no real benefits. Attitudes were shown to be associated with underlying values associated with scientific progress rather than with age, gender or education, and although there were a few differences in the quantitative data based on religious affiliation, these tended to be small effects. Likewise in the focus groups there was little direct appeal to religion, but the main themes were ‘interfering with nature’ and the ‘status of the embryo’, with the latter being used more effectively to try to close down further discussion. In general there was a close correspondence between the media analysis and focus group responses, possibly demonstrating the importance of media as a resource, or that the media reflect publi

The practice of evaluating interaction with devices is embedded in disciplines such as human-computer interaction and cognitive ergonomics, including concepts such as affordances, error analysis, skill, rule and knowledge based behaviour and decision making biases. This paper considers the way in which the approach that has been routinely applied to displays and control design within the control and transport domains can be transferred to the context of medical devices. The importance of considering the context in which medical devices are used and implemented is presented, and the need for a systems approach to medical device design is emphasised. Five case studies from medical device control and display design are presented as an aide to developing an understanding of the relationship between device design and resultant behaviours. On the basis of these case studies, four types of mediating factors (catalysts, enablers, facilitators and enhancers) are proposed and a model to describe the link between device design, user, context and consequences is presented.

The debate concerning how many participants represents a sufficient number for interaction testing is well-established and long-running, with prominent contributions arguing that five users provide a good benchmark when seeking to discover interaction problems. We argue that adoption of five users in this context is often done with little understanding of the basis for, or implications of, the decision. We present an analysis of relevant research to clarify the meaning of the five-user assumption and to examine the way in which the original research that suggested it has been applied. This includes its blind adoption and application in some studies, and complaints about its inadequacies in others. We argue that the five-user assumption is often misunderstood, not only in the field of Human-Computer Interaction, but also in fields such as medical device design, or in business and information applications. The analysis that we present allows us to define a systematic approach for monitoring the sample discovery likelihood, in formative and summative evaluations, and for gathering information in order to make critical decisions during the interaction testing, while respecting the aim of the evaluation and allotted budget. This approach -- which we call the Grounded Procedure -- is introduced and its value argued.

Background: It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. Methods: A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. Results: A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. Conclusion: There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision making processes may assist man

Background Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. Conclusions Medical device manufacturers often d

The practice of evaluating interaction with devices is embedded in disciplines such as human-computer interaction and cognitive ergonomics, including concepts such as affordances, error analysis, skill, rule and knowledge based behaviour and decision making biases. This paper considers the way in which the approach that has been routinely applied to displays and control design within the control and transport domains can be transferred to the context of medical devices. The importance of considering the context in which medical devices are used and implemented is presented, and the need for a systems approach to medical device design is emphasised. Five case studies from medical device control and display design are presented as an aide to developing an understanding of the relationship between device design and resultant behaviours. On the basis of these case studies, four types of mediating factors (catalysts, enablers, facilitators and enhancers) are proposed and a model to describe the link between device design, user, context and consequences is presented.

Background: It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. Methods: A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. Results: A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. Conclusion: There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision making processes may assist man

The debate concerning how many participants represents a sufficient number for interaction testing is well-established and long-running, with prominent contributions arguing that five users provide a good benchmark when seeking to discover interaction problems. We argue that adoption of five users in this context is often done with little understanding of the basis for, or implications of, the decision. We present an analysis of relevant research to clarify the meaning of the five-user assumption and to examine the way in which the original research that suggested it has been applied. This includes its blind adoption and application in some studies, and complaints about its inadequacies in others. We argue that the five-user assumption is often misunderstood, not only in the field of Human-Computer Interaction, but also in fields such as medical device design, or in business and information applications. The analysis that we present allows us to define a systematic approach for monitoring the sample discovery likelihood, in formative and summative evaluations, and for gathering information in order to make critical decisions during the interaction testing, while respecting the aim of the evaluation and allotted budget. This approach -- which we call the Grounded Procedure -- is introduced and its value argued.

Background Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. Conclusions Medical device manufacturers often d

Access to reliable and timely information ensures that decision-makers can operate effectively. The motivations and challenges of parliamentarians and policy-makers in accessing evidence have been well documented in the policy literature. However, there has been little focus on research-providers. Understanding both the demand- and the supply-side of research engagement is imperative to enhancing impactful interactions. Here, we examine the broader experiences, motivations and challenges of UK-based research professionals engaging with research-users relevant to policy-making and scrutiny in the UK using a nationwide online questionnaire. The context of the survey partly involved contributing to the UK Evidence Information Service (EIS), a proposed rapid match-making service to facilitate interaction between parliamentary arenas that use evidence and research-providers. Our findings reveal, at least for this sub-sample who responded, that there are gender-related differences in policy-related experience, motivations, incentives and challenges for research professionals to contribute to evidence-informed decision-making through initiatives such as the EIS. Male and female participants were equally likely to have policy experience; however, males reported both significantly broader engagement with the research-users included in the survey and significantly higher levels of engagement with each research-user. Reported incentives for engagement included understanding what the evidence will be used for, guidance on style and content of contribution, and acknowledgement of contributions by the policymaker or elected official. Female participants were significantly more likely to select the guidance-related options. The main reported barrier was workload. We discuss how academia-policy engagement initiatives can best address these issues in ways that enhance the integration of research evidence with policy and practice across the UK.

Background: It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. Methods: A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. Results: A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. Conclusion: There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision making processes may assist man

The practice of evaluating interaction with devices is embedded in disciplines such as human-computer interaction and cognitive ergonomics, including concepts such as affordances, error analysis, skill, rule and knowledge based behaviour and decision making biases. This paper considers the way in which the approach that has been routinely applied to displays and control design within the control and transport domains can be transferred to the context of medical devices. The importance of considering the context in which medical devices are used and implemented is presented, and the need for a systems approach to medical device design is emphasised. Five case studies from medical device control and display design are presented as an aide to developing an understanding of the relationship between device design and resultant behaviours. On the basis of these case studies, four types of mediating factors (catalysts, enablers, facilitators and enhancers) are proposed and a model to describe the link between device design, user, context and consequences is presented.

The debate concerning how many participants represents a sufficient number for interaction testing is well-established and long-running, with prominent contributions arguing that five users provide a good benchmark when seeking to discover interaction problems. We argue that adoption of five users in this context is often done with little understanding of the basis for, or implications of, the decision. We present an analysis of relevant research to clarify the meaning of the five-user assumption and to examine the way in which the original research that suggested it has been applied. This includes its blind adoption and application in some studies, and complaints about its inadequacies in others. We argue that the five-user assumption is often misunderstood, not only in the field of Human-Computer Interaction, but also in fields such as medical device design, or in business and information applications. The analysis that we present allows us to define a systematic approach for monitoring the sample discovery likelihood, in formative and summative evaluations, and for gathering information in order to make critical decisions during the interaction testing, while respecting the aim of the evaluation and allotted budget. This approach -- which we call the Grounded Procedure -- is introduced and its value argued.

Background Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. Conclusions Medical device manufacturers often d

The practice of evaluating interaction with devices is embedded in disciplines such as human-computer interaction and cognitive ergonomics, including concepts such as affordances, error analysis, skill, rule and knowledge based behaviour and decision making biases. This paper considers the way in which the approach that has been routinely applied to displays and control design within the control and transport domains can be transferred to the context of medical devices. The importance of considering the context in which medical devices are used and implemented is presented, and the need for a systems approach to medical device design is emphasised. Five case studies from medical device control and display design are presented as an aide to developing an understanding of the relationship between device design and resultant behaviours. On the basis of these case studies, four types of mediating factors (catalysts, enablers, facilitators and enhancers) are proposed and a model to describe the link between device design, user, context and consequences is presented.

The debate concerning how many participants represents a sufficient number for interaction testing is well-established and long-running, with prominent contributions arguing that five users provide a good benchmark when seeking to discover interaction problems. We argue that adoption of five users in this context is often done with little understanding of the basis for, or implications of, the decision. We present an analysis of relevant research to clarify the meaning of the five-user assumption and to examine the way in which the original research that suggested it has been applied. This includes its blind adoption and application in some studies, and complaints about its inadequacies in others. We argue that the five-user assumption is often misunderstood, not only in the field of Human-Computer Interaction, but also in fields such as medical device design, or in business and information applications. The analysis that we present allows us to define a systematic approach for monitoring the sample discovery likelihood, in formative and summative evaluations, and for gathering information in order to make critical decisions during the interaction testing, while respecting the aim of the evaluation and allotted budget. This approach -- which we call the Grounded Procedure -- is introduced and its value argued.

Background: It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. Methods: A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. Results: A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. Conclusion: There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision making processes may assist man

Background Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. Conclusions Medical device manufacturers often d

The practice of evaluating interaction with devices is embedded in disciplines such as human-computer interaction and cognitive ergonomics, including concepts such as affordances, error analysis, skill, rule and knowledge based behaviour and decision making biases. This paper considers the way in which the approach that has been routinely applied to displays and control design within the control and transport domains can be transferred to the context of medical devices. The importance of considering the context in which medical devices are used and implemented is presented, and the need for a systems approach to medical device design is emphasised. Five case studies from medical device control and display design are presented as an aide to developing an understanding of the relationship between device design and resultant behaviours. On the basis of these case studies, four types of mediating factors (catalysts, enablers, facilitators and enhancers) are proposed and a model to describe the link between device design, user, context and consequences is presented.

Background: It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. Methods: A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. Results: A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. Conclusion: There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision making processes may assist man

The debate concerning how many participants represents a sufficient number for interaction testing is well-established and long-running, with prominent contributions arguing that five users provide a good benchmark when seeking to discover interaction problems. We argue that adoption of five users in this context is often done with little understanding of the basis for, or implications of, the decision. We present an analysis of relevant research to clarify the meaning of the five-user assumption and to examine the way in which the original research that suggested it has been applied. This includes its blind adoption and application in some studies, and complaints about its inadequacies in others. We argue that the five-user assumption is often misunderstood, not only in the field of Human-Computer Interaction, but also in fields such as medical device design, or in business and information applications. The analysis that we present allows us to define a systematic approach for monitoring the sample discovery likelihood, in formative and summative evaluations, and for gathering information in order to make critical decisions during the interaction testing, while respecting the aim of the evaluation and allotted budget. This approach -- which we call the Grounded Procedure -- is introduced and its value argued.

Background Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. Conclusions Medical device manufacturers often d