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An increased use of medical devices has been assumed to be a major cause of rising healthcare expenditures. Nations around the world are trying to keep costs down, but strong incentives still exist for the development and use of new devices. Innovation is, however, never exclusively good or bad and it is not easy to evaluate the net effect. Theories and empirical research on innovation have been produced for more than 100 years. In this, the diffusion of innovations has attracted the most interest, while other areas, such as the integration of technologies, have been less thoroughly researched. This thesis presents a model of medical device innovation in hospitals – from the first idea and invention effort to regular use of a new technology. The suggested model is built on three fundaments: (1) academic innovation literature, (2) empirical studies, and (3) observations of on-going innovation processes. The model is a synthesis of the accumulated knowledge in different innovation research traditions, and of empirical studies of the Swedish healthcare system and the medical device industry. The aim is to give a comprehensive picture of the innovation process, and to provide a theoretical model, which can be used for studying and influencing the paths of medical device innovations into healthcare practice. In order to achieve a balanced rate of change, with long-term societal benefits, an inter-disciplinary approach is necessary in the planning and regulation of medical device innovation. The new model combines academic views with political/entrepreneurial and healthcare views. Innovation, in this model, is suggested to occur in three integrated activity domains: invention, diffusion, and deployment. A great number of factors that influence these activities are investigated and described, and different roles and incentives are discussed. Deviations from traditional innovation theory are for example: (a) integration of invention activities as having an impact on later events; (b) inclusion of the inventor/developer as a main actor also in the diffusion and deployment domains; (c) increased focus of the concept of technology cluster innovation, and (d) the rationality of use and abandonment of knowledge as factors to be included in the estimation of consequences of innovation. Finally, the thesis suggests a number of model and methodology improvements and policy implications for management of innovation in hospitals.

Background: Sweden has undertaken many national, regional, and local initiatives to improve patient safety since the mid-2000s, but solid evidence of effectiveness for many solutions is often lacking. Nurses play a vital role in patient safety, constituting 71% of the workforce in Swedish health care. This interview study aimed to explore perceived facilitators and barriers influencing patient safety among nurses involved in the direct provision of care. Considering the importance of nurses with regard to patient safety, this knowledge could facilitate the development and implementation of better solutions. Methods: A qualitative study with semi-structured individual interviews was carried out. The study population consisted of 12 registered nurses at general hospitals in Sweden. Data were analyzed using qualitative content analysis. Results: The nurses identified 22 factors that influenced patient safety within seven categories: 'patient factors', 'individual staff factors', 'team factors', 'task and technology factors', 'work environment factors', 'organizational and management factors', and 'institutional context factors'. Twelve of the 22 factors functioned as both facilitators and barriers, six factors were perceived only as barriers, and four only as facilitators. There were no specific patterns showing that barriers or facilitators were more common in any category. Conclusion: A broad range of factors are important for patient safety according to registered nurses working in general hospitals in Sweden. The nurses identified facilitators and barriers to improved patient safety at multiple system levels, indicating that complex multifaceted initiatives are required to address patient safety issues. This study encourages further research to achieve a more explicit understanding of the problems and solutions to patient safety. ; CC BY 2.0 Correspondence: mikaela.ridelberg@liu.se Department of Medical and Health Sciences, Division of Health Care Analysis, Linköping University, Linköping 581 83, Sweden This work was supported financially by the Swedish Association of Local Authorities and Regions (SALAR) [SKR]. The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

Background There is widespread recognition of the problem of unsafe care and extensive efforts have been made over the last 15 years to improve patient safety. In Sweden, a new patient safety law obliges the 21 county councils to assemble a yearly patient safety report (PSR). The aim of this study was to describe the patient safety work carried out in Sweden by analysing the PSRs with regard to the structure, process and result elements reported, and to investigate the perceived usefulness of the PSRs as a tool to achieve improved patient safety. Methods The study was based on two sources of data: patient safety reports obtained from county councils in Sweden published in 2014 and a survey of health care practitioners with strategic positions in patient safety work, acting as key informants for their county councils. Answers to open-ended questions were analysed using conventional content analysis. Results A total of 14 structure elements, 31 process elements and 23 outcome elements were identified. The most frequently reported structure elements were groups devoted to working with antibiotics issues and electronic incident reporting systems. The PSRs were perceived to provide a structure for patient safety work, enhance the focus on patient safety and contribute to learning about patient safety. Conclusion Patient safety work carried out in Sweden, as described in annual PSRs, features a wide range of structure, process and result elements. According to health care practitioners with strategic positions in the county councils' patient safety work, the PSRs are perceived as useful at various system levels. ; Funding agencies: Swedish National Board of Health and Welfare

Background: There is widespread recognition of the problem of unsafe care and extensive efforts have been made over the last 15 years to improve patient safety. In Sweden, a new patient safety law obliges the 21 county councils to assemble a yearly patient safety report (PSR). The aim of this study was to describe the patient safety work carried out in Sweden by analysing the PSRs with regard to the structure, process and result elements reported, and to investigate the perceived usefulness of the PSRs as a tool to achieve improved patient safety. Methods: The study was based on two sources of data: patient safety reports obtained from county councils in Sweden published in 2014 and a survey of health care practitioners with strategic positions in patient safety work, acting as key informants for their county councils. Answers to open-ended questions were analysed using conventional content analysis. Results: A total of 14 structure elements, 31 process elements and 23 outcome elements were identified. The most frequently reported structure elements were groups devoted to working with antibiotics issues and electronic incident reporting systems. The PSRs were perceived to provide a structure for patient safety work, enhance the focus on patient safety and contribute to learning about patient safety. Conclusion: Patient safety work carried out in Sweden, as described in annual PSRs, features a wide range of structure, process and result elements. According to health care practitioners with strategic positions in the county councils' patient safety work, the PSRs are perceived as useful at various system levels. ; CC BY 4.0 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Correspondence: siw.carlfjord@liu.se

Background: The introduction of biological drugs involved a fundamental change in the treatment of rheumatoid arthritis (RA). The extent to which biological drugs are prescribed to RA patients in different regions in Sweden varies greatly. Previous research has indicated that differences in health care practice at the regional level might obscure differences at the individual level. The objective of this study is to explore what influences individual rheumatologists decisions when prescribing biological drugs. Method: Semi-structured interviews, utilizing closed-and open-ended questions, were conducted with senior rheumatologists, selected through a mix of random and purposive sampling. The interview questions consisted of two parts, with a "parallel mixed method" approach. In the first and main part, open-ended exploratory questions were posed about factors influencing prescription. In the second part, the rheumatologists were asked to rate predefined factors that might influence their prescription decisions. The Consolidated Framework for Implementation Research (CFIR) was used as a conceptual framework for data collection and analysis. Results: Twenty-six rheumatologists were interviewed. A constellation of various factors and their interaction influenced rheumatologists prescribing decisions, including the individual rheumatologists experiences and perceptions of the evidence, the structure of the department including responsibility for costs, peer pressure, political and administrative influences, and participation in clinical trials. The patient as an actor emerged as an important factor. Hence, factors both at organizational and individual levels influenced the prescribing of biological drugs. The factors should not be seen as individual influences but were described as influencing prescription in an interactive, nonlinear way. Conclusions: Potential factors explaining differences in prescription practice are experience and perception of the evidence on the individual level and the structure of the department and participation in clinical trials on the organizational level. The influence of patient attitudes and preferences and interpretation of scientific evidence seemed to be somewhat contradictory in the qualitative responses as compared to the quantitative rating, and this needs further exploration. An implication of the present study is that in addition to scientific knowledge, attempts to influence prescription behavior need to be multifactorial and account for interactions of factors between different actors.

Background Many of society's health problems require research-based knowledge acted on by healthcare practitioners together with implementation of political measures from governmental agencies. However, there has been limited knowledge exchange between implementation science and policy implementation research, which has been conducted since the early 1970s. Based on a narrative review of selective literature on implementation science and policy implementation research, the aim of this paper is to describe the characteristics of policy implementation research, analyze key similarities and differences between this field and implementation science, and discuss how knowledge assembled in policy implementation research could inform implementation science. Discussion Following a brief overview of policy implementation research, several aspects of the two fields were described and compared: the purpose and origins of the research; the characteristics of the research; the development and use of theory; determinants of change (independent variables); and the impact of implementation (dependent variables). The comparative analysis showed that there are many similarities between the two fields, yet there are also profound differences. Still, important learning may be derived from several aspects of policy implementation research, including issues related to the influence of the context of implementation and the values and norms of the implementers (the healthcare practitioners) on implementation processes. Relevant research on various associated policy topics, including The Advocacy Coalition Framework, Governance Theory, and Institutional Theory, may also contribute to improved understanding of the difficulties of implementing evidence in healthcare. Implementation science is at a relatively early stage of development, and advancement of the field would benefit from accounting for knowledge beyond the parameters of the immediate implementation science literature. Summary There are many common issues in policy implementation research and implementation science. Research in both fields deals with the challenges of translating intentions into desired changes. Important learning may be derived from several aspects of policy implementation research.

Background: National, regional and local activities to improve patient safety in Sweden have increased over the last decade. There are high ambitions for improved patient safety in Sweden. This study surveyed health care professionals who held key positions in their county council's patient safety work to investigate their perceptions of the conditions for this work, factors they believe have been most important in reaching the current level of patient safety and factors they believe would be most important for achieving improved patient safety in the future. Methods: The study population consisted of 218 health care professionals holding strategic positions in patient safety work in Swedish county councils. Using a questionnaire, the following topics were analysed in this study: profession/occupation; number of years involved in a designated task on patient safety issues; knowledge/overview of the county council's patient safety work; ability to influence this work; conditions for this work; and the importance of various factors for current and future levels of patient safety. Results: The response rate to the questionnaire was 79%. The conditions that had the highest number of responses in complete agreement were "patients' involvement is important for patient safety" and "patient safety work has good support from the county council's management". Factors that were considered most important for achieving the current level of patient safety were root cause and risk analyses, incident reporting and the Swedish Patient Safety Law. An organizational culture that encourages reporting and avoids blame was considered most important for improved patient safety in the future, closely followed by improved communication between health care practitioners and patients. Conclusion: Health care professionals with important positions in the Swedish county councils' patient safety work believe that conditions for this work are somewhat constrained. They attribute the current levels of patient safety to a broad range of factors and believe that many different solutions can contribute to enhanced patient safety in the future, suggesting that this work must be multifactorial. ; CC BY 2.0 Correspondence: mikaela.nygren@liu.se Department of Medical and Health Sciences, Division of Health Care Analysis, Linköping University, 581 83 Linköping, Sweden This work was financially supported by the Swedish Association of Local Authorities and Regions (SALAR) [SKR].