Suchergebnisse

Part 3: Section 2: Sustainable and Responsible Innovation ; International audience ; Healthcare is of central importance to all communities and generally has a high political profile. Access and availability of care, rising costs, and emerging new relationships between experts (doctors and nurses) and users (patients, citizens) pose new challenges. ICT-based innovation is often proposed as a solution, accompanied by optimistic accounts of its transformative potential, both for the developing world and the developed. These ambitions also implicitly endorse new social agreements and business models. In this respect, as in others, technology is not neutral or simple in the service of modernization; it has its own politics. This paper discusses ICT innovation in healthcare in these terms focused on issues of sustainability and responsibility adapting two economic concepts: redistribution and externalities. The analysis reveals ICT innovation in health care as essentially raising 'trans-scientific' questions – matters of policy and intergenerational ethics rather than narrow science

To evaluate the implementation and adoption of the NHS detailed care records service in "early adopter" hospitals in England.Theoretically informed, longitudinal qualitative evaluation based on case studies.12 "early adopter" NHS acute hospitals and specialist care settings studied over two and a half years.Data were collected through in depth interviews, observations, and relevant documents relating directly to case study sites and to wider national developments that were perceived to impact on the implementation strategy. Data were thematically analysed, initially within and then across cases. The dataset consisted of 431 semistructured interviews with key stakeholders, including hospital staff, developers, and governmental stakeholders; 590 hours of observations of strategic meetings and use of the software in context; 334 sets of notes from observations, researchers' field notes, and notes from national conferences; 809 NHS documents; and 58 regional and national documents.Implementation has proceeded more slowly, with a narrower scope and substantially less clinical functionality than was originally planned. The national strategy had considerable local consequences (summarised under five key themes), and wider national developments impacted heavily on implementation and adoption. More specifically, delays related to unrealistic expectations about the capabilities of systems; the time needed to build, configure, and customise the software; the work needed to ensure that systems were supporting provision of care; and the needs of end users for training and support. Other factors hampering progress included the changing milieu of NHS policy and priorities; repeatedly renegotiated national contracts; different stages of development of diverse NHS care records service systems; and a complex communication process between different stakeholders, along with contractual arrangements that largely excluded NHS providers. There was early evidence that deploying systems resulted in important learning within and between ...

To describe and evaluate the implementation and adoption of detailed electronic health records in secondary care in England and thereby provide early feedback for the ongoing local and national rollout of the NHS Care Records Service.A mixed methods, longitudinal, multisite, socio-technical case study.Five NHS acute hospital and mental health trusts that have been the focus of early implementation efforts and at which interim data collection and analysis are complete. Data sources and analysis Dataset for the evaluation consists of semi-structured interviews, documents and field notes, observations, and quantitative data. Qualitative data were analysed thematically with a socio-technical coding matrix, combined with additional themes that emerged from the data. Main results Hospital electronic health record applications are being developed and implemented far more slowly than was originally envisioned; the top-down, standardised approach has needed to evolve to admit more variation and greater local choice, which hospital trusts want in order to support local activity. Despite considerable delays and frustrations, support for electronic health records remains strong, including from NHS clinicians. Political and financial factors are now perceived to threaten nationwide implementation of electronic health records. Interviewees identified a range of consequences of long term, centrally negotiated contracts to deliver the NHS Care Records Service in secondary care, particularly as NHS trusts themselves are not party to these contracts. These include convoluted communication channels between different stakeholders, unrealistic deployment timelines, delays, and applications that could not quickly respond to changing national and local NHS priorities. Our data suggest support for a "middle-out" approach to implementing hospital electronic health records, combining government direction with increased local autonomy, and for restricting detailed electronic health record sharing to local health communities.Experiences ...

Objective : Human and Organizational Factors (HOF) studies in health technology involve human beings and thus require Institutional Review Board (IRB) approval. Yet HOF studies have specific constraints and methods that may not fit standard regulations and IRB practices. Gaining IRB approval may pose difficulties for HOF researchers. This paper aims to provide a first overview of HOF study challenges to get IRB review by exploring differences and best practices across different countries. Methods : HOF researchers were contacted by email to provide a testimony about their experience with IRB review and approval. Testimonies were thematically analyzed and synthesized to identify and discuss shared themes. Results : Researchers from seven European countries, Argentina, Canada, Australia, and the United States answered the call. Four themes emerged that indicate shared challenges in legislation, IRB inefficiencies and inconsistencies, general regulation and costs, and lack of HOF study knowledge by IRB members. We propose a model for IRB review of HOF studies based on best practices. Conclusion : International criteria are needed that define low and high-risk HOF studies, to allow identification of studies that can undergo an expedited (or exempted) process from those that need full IRB review. Enhancing IRB processes in such a way would be beneficial to the conduct of HOF studies. Greater knowledge and promotion of HOF methods and evidence-based HOF study designs may support the evolving discipline. Based on these insights, training and guidance to IRB members may be developed to support them in ensuring that appropriate ethical issues for HOF studies are considered.

OBJECTIVE: Human and Organizational Factors (HOF) studies in health technology involve human beings and thus require Institutional Review Board (IRB) approval. Yet HOF studies have specific constraints and methods that may not fit standard regulations and IRB practices. Gaining IRB approval may pose difficulties for HOF researchers. This paper aims to provide a first overview of HOF study challenges to get IRB review by exploring differences and best practices across different countries. METHODS: HOF researchers were contacted by email to provide a testimony about their experience with IRB review and approval. Testimonies were thematically analyzed and synthesized to identify and discuss shared themes. RESULTS: Researchers from seven European countries, Argentina, Canada, Australia, and the United States answered the call. Four themes emerged that indicate shared challenges in legislation, IRB inefficiencies and inconsistencies, general regulation and costs, and lack of HOF study knowledge by IRB members. We propose a model for IRB review of HOF studies based on best practices. CONCLUSION: International criteria are needed that define low and high-risk HOF studies, to allow identification of studies that can undergo an expedited (or exempted) process from those that need full IRB review. Enhancing IRB processes in such a way would be beneficial to the conduct of HOF studies. Greater knowledge and promotion of HOF methods and evidence-based HOF study designs may support the evolving discipline. Based on these insights, training and guidance to IRB members may be developed to support them in ensuring that appropriate ethical issues for HOF studies are considered. ; Peer reviewed

Objective: Human and Organizational Factors (HOF) studies in health technology involve human beings and thus require Institutional Review Board (IRB) approval. Yet HOF studies have specific constraints and methods that may not fit standard regulations and IRB practices. Gaining IRB approval may pose difficulties for HOF researchers. This paper aims to provide a first overview of HOF study challenges to get IRB review by exploring differences and best practices across different countries. Methods: HOF researchers were contacted by email to provide a testimony about their experience with IRB review and approval. Testimonies were thematically analyzed and synthesized to identify and discuss shared themes. Results: Researchers from seven European countries, Argentina, Canada, Australia, and the United States answered the call. Four themes emerged that indicate shared challenges in legislation, IRB inefficiencies and inconsistencies, general regulation and costs, and lack of HOF study knowledge by IRB members. We propose a model for IRB review of HOF studies based on best practices. Conclusion: International criteria are needed that define low and high-risk HOF studies, to allow identification of studies that can undergo an expedited (or exempted) process from those that need full IRB review. Enhancing IRB processes in such a way would be beneficial to the conduct of HOF studies. Greater knowledge and promotion of HOF methods and evidence-based HOF study designs may support the evolving discipline. Based on these insights, training and guidance to IRB members may be developed to support them in ensuring that appropriate ethical issues for HOF studies are considered.