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International audience ; Background Contemporary bioscience sometimes demands vast sample sizes and there is often then no choice but to synthesise data across several studies and to undertake an appropriate pooled analysis. This same need is also faced in health-services and socio-economic research. When a pooled analysis is required, analytic efficiency and flexibility are often best served by combining the individual-level data from all sources and analysing them as a single large data set. But ethico-legal constraints, including the wording of consent forms and privacy legislation, often prohibit or discourage the sharing of individual-level data, particularly across national or other jurisdictional boundaries. This leads to a fundamental conflict in competing public goods: individual-level analysis is desirable from a scientific perspective, but is prevented by ethico-legal considerations that are entirely valid. Methods DataSHIELD (Data Aggregation Through Anonymous Summary-statistics from Harmonized Individual-levEL Databases), provides a simple approach to analysing pooled data that circumvents this conflict. This is achieved via parallelized analysis and modern distributed computing and, in one key setting, takes advantage of the properties of the updating algorithm for generalized linear models (GLMs). Results The conceptual use of DataSHIELD is illustrated in two different settings. Conclusions As the study of the aetiological architecture of chronic diseases advances to encompass more complex causal pathways - e.g. to include the joint effects of genes, life-style and environment - sample size requirements will increase further and the analysis of pooled individual-level data will become ever more important. An aim of this conceptual paper is to encourage others to address the challenges and opportunities that DataSHIELD presents, and to explore potential extensions, for example to its use when different data sources hold different data on the same individuals.

Background Despite earlier doubts, a string of recent successes indicates that if sample sizes are large enough, it is possible—both in theory and in practice—to identify and replicate genetic associations with common complex diseases. But human genome epidemiology is expensive and, from a strategic perspective, it is still unclear what 'large enough' really means. This question has critical implications for governments, funding agencies, bioscientists and the tax-paying public. Difficult strategic decisions with imposing price tags and important opportunity costs must be taken.

ABSTRACT
ObjectivesThe effective exploitation of what are often called big data is increasingly important. They provide the evidence in evidence-based health care and underpin scientific progress in many domains including social/economic policy. Typically, an optimal analysis involves working directly with microdata; i.e. the detailed data relating to each individual in the dataset. But there are many ethico-legal and other governance restrictions on physically sharing microdata. Furthermore, researchers or institutions may have an extensive intellectual property investment in complex microdata and although keen for other researchers to analyse their data they may not wish to give them a physical copy. These restrictions can discourage the use of optimum approaches to analysing pivotal data and slow scientific progress. Data science groups across the world are exploring privacy-protected approaches to analysing microdata without having to physically share the data.
ApproachA two day international workshop was arranged focussing on privacy protected approaches to data analysis – particularly federated analysis where raw data remain at their original site of collection. The workshop considered the range of approaches that exist, and those that are currently being developed. It explored the strengths, weaknesses, opportunities and challenges associated with these methods and identified situations where specific approaches have a particularly important role. The workshop included a number of practical sessions where potential users could watch demonstrations of the various approaches in action and run analyses themselves.
ResultsThe Data Analysis with Privacy Protection for Epidemiological Research (DAPPER) workshop was held 22-23rd August 2016, Bristol. We report back to the broader community on the outcomes of this workshop that focussed on exploring current approaches, tools and technical solutions that facilitate sensitive data to be shared and analysed.
ConclusionsThe workshop has helped map out key opportunities and challenges and assisted potential users, developers and other stakeholders (e.g. funders/journals) to recognise the strengths and weaknesses of different privacy protected analytic approaches. The workshop will encourage further methodological work in this field and better informed application of existing methods.

<b><i>Background:</i></b> DataSHIELD (Data Aggregation Through Anonymous Summary-statistics from Harmonised Individual levEL Databases) has been proposed to facilitate the co-analysis of individual-level data from multiple studies without physically sharing the data. In a previous paper, we investigated whether DataSHIELD could protect participant confidentiality in accordance with UK law. In this follow-up paper, we investigate whether DataSHIELD addresses a broader range of ethics-related data-sharing concerns. <b><i>Methods:</i></b> Ethics-related data-sharing concerns of Institutional Review Boards, ethics experts, international research consortia and research participants were identified through a literature search and systematically examined at a multidisciplinary workshop to determine whether DataSHIELD proposes mechanisms which can address these concerns. <b><i>Results:</i></b> DataSHIELD addresses several ethics-related data-sharing concerns related to privacy, confidentiality, and the protection of the research participant's rights while sharing data and after the data have been shared. The data remain entirely under the direct management of the study that collected them. Data processing commands are strictly supervised, and the data are queried in a protected environment. Issues related to the return of individual research results when data are shared are eliminated; the responsibility for return remains at the study of origin. <b><i>Conclusion:</i></b> DataSHIELD can provide an innovative and robust solution for addressing commonly encountered ethics-related data-sharing concerns.

Background: Because no single person or group holds knowledge about all aspects of research, mechanisms are needed to support knowledge exchange and engagement. Expertise in the research setting necessarily includes scientific and methodological expertise, but also expertise gained through the experience of participating in research and/or being a recipient of research outcomes (as a patient or member of the public). Engagement is, by its nature, reciprocal and relational: the process of engaging research participants, patients, citizens and others (the many 'publics' of engagement) brings them closer to the research but also brings the research closer to them. When translating research into practice, engaging the public and other stakeholders is explicitly intended to make the outcomes of translation relevant to its constituency of users. Methods: In practice, engagement faces numerous challenges and is often time-consuming, expensive and 'thorny' work. We explore the epistemic and ontological considerations and implications of four common critiques of engagement methodologies that contest: representativeness, communication and articulation, impacts and outcome, and democracy. The ECOUTER (Employing COnceptUal schema for policy and Translation Engagement in Research) methodology addresses problems of representation and epistemic foundationalism using a methodology that asks, "How could it be otherwise?" ECOUTER affords the possibility of engagement where spatial and temporal constraints are present, relying on saturation as a method of 'keeping open' the possible considerations that might emerge and including reflexive use of qualitative analytic methods. Results: This paper describes the ECOUTER process, focusing on one worked example and detailing lessons learned from four other pilots. ECOUTER uses mind-mapping techniques to 'open up' engagement, iteratively and organically. ECOUTER aims to balance the breadth, accessibility and user-determination of the scope of engagement. An ECOUTER exercise comprises four stages: (1) engagement and knowledge exchange; (2) analysis of mindmap contributions; (3) development of a conceptual schema (i.e. a map of concepts and their relationship); and (4) feedback, refinement and development of recommendations. Conclusion: ECOUTER refuses fixed truths but also refuses a fixed nature. Its promise lies in its flexibility, adaptability and openness. ECOUTER will be formed and re-formed by the needs and creativity of those who use it.

Background: Because no single person or group holds knowledge about all aspects of research, mechanisms are needed to support knowledge exchange and engagement. Expertise in the research setting necessarily includes scientific and methodological expertise, but also expertise gained through the experience of participating in research and/or being a recipient of research outcomes (as a patient or member of the public). Engagement is, by its nature, reciprocal and relational: the process of engaging research participants, patients, citizens and others (the many 'publics' of engagement) brings them closer to the research but also brings the research closer to them. When translating research into practice, engaging the public and other stakeholders is explicitly intended to make the outcomes of translation relevant to its constituency of users.Methods: In practice, engagement faces numerous challenges and is often time-consuming, expensive and 'thorny' work. We explore the epistemic and ontological considerations and implications of four common critiques of engagement methodologies that contest: representativeness, communication and articulation, impacts and outcome, and democracy. The ECOUTER (Employing COnceptUal schema for policy and Translation Engagement in Research) methodology addresses problems of representation and epistemic foundationalism using a methodology that asks, "How could it be otherwise?" ECOUTER affords the possibility of engagement where spatial and temporal constraints are present, relying on saturation as a method of 'keeping open' the possible considerations that might emerge and including reflexive use of qualitative analytic methods.Results: This paper describes the ECOUTER process, focusing on one worked example and detailing lessons learned from four other pilots. ECOUTER uses mind-mapping techniques to 'open up' engagement, iteratively and organically. ECOUTER aims to balance the breadth, accessibility and user-determination of the scope of engagement. An ECOUTER exercise comprises four ...

Background: Because no single person or group holds knowledge about all aspects of research, mechanisms are needed to support knowledge exchange and engagement. Expertise in the research setting necessarily includes scientific and methodological expertise, but also expertise gained through the experience of participating in research and/or being a recipient of research outcomes (as a patient or member of the public). Engagement is, by its nature, reciprocal and relational: the process of engaging research participants, patients, citizens and others (the many 'publics' of engagement) brings them closer to the research but also brings the research closer to them. When translating research into practice, engaging the public and other stakeholders is explicitly intended to make the outcomes of translation relevant to its constituency of users. Methods: In practice, engagement faces numerous challenges and is often time-consuming, expensive and 'thorny' work. We explore the epistemic and ontological considerations and implications of four common critiques of engagement methodologies that contest: representativeness, communication and articulation, impacts and outcome, and democracy. The ECOUTER (Employing COnceptUal schema for policy and Translation Engagement in Research) methodology addresses problems of representation and epistemic foundationalism using a methodology that asks, "How could it be otherwise?" ECOUTER affords the possibility of engagement where spatial and temporal constraints are present, relying on saturation as a method of 'keeping open' the possible considerations that might emerge and including reflexive use of qualitative analytic methods. Results: This paper describes the ECOUTER process, focusing on one worked example and detailing lessons learned from four other pilots. ECOUTER uses mind-mapping techniques to 'open up' engagement, iteratively and organically. ECOUTER aims to balance the breadth, accessibility and user-determination of the scope of engagement. An ECOUTER exercise comprises four stages: (1) engagement and knowledge exchange; (2) analysis of mindmap contributions; (3) development of a conceptual schema (i.e. a map of concepts and their relationship); and (4) feedback, refinement and development of recommendations. Conclusion: ECOUTER refuses fixed truths but also refuses a fixed nature. Its promise lies in its flexibility, adaptability and openness. ECOUTER will be formed and re-formed by the needs and creativity of those who use it.

Governments around the world are seeing the locality as a key arena for effecting changes in governance, restructuring state/civil society relations and achieving sustainable growth. This is the first book to critically analyse this shift towards localism in planning through exploring neighbourhood planning; one of the fastest growing, most popular and most contentious contemporary planning initiatives. Bringing together original empirical research with critical perspectives on governance and planning, the book engages with broader debates on the purposes of planning, the construction of active citizenship, the uneven geographies of localism and the extent to which power is actually being devolved. Setting this within an international context with cases from the US, Australia and France the book reflects on the possibilities for the emergence of a more progressive form of localism

Directly elected mayors are political leaders who are selected directly by citizens and head multi-functional local government authorities. This book examines the contexts, features and debates around this model of leadership, and how in practice political leadership is exercised through it. The book draws on examples from Europe, the US, and Australasia to examine the impacts, practices, and debates of mayoral leadership in different cities and countries. Themes that recur throughout include the formal and informal powers that mayors exercise, their relationships with other actors in governance - both inside municipalities and in broader governance networks - and the advantages and disadvantages of the mayoral model. Both qualitative and quantitative approaches are used to build a picture of views of and on directly elected mayors in different contexts from across the globe. This book will be a valuable resource for those studying or researching public policy, public management, urban studies, politics, law, and planning

At a time when neoliberal and conservative politics are again in the ascendency and social democracy is waning, Australian public policy re-engages with the values and goals of progressive public policy in Australia and the difficulties faced in re-affirming them. It brings together leading authors to explore economic, environmental, social, cultural, political and indigenous issues. It examines trends and current policy directions and outlines progressive alternatives that challenge and extend current thinking. While focused on Australia, the contributors offer valuable insights for people in other countries committed to social justice and those engaged in the ongoing contest between neo-liberalism and social democracy. This is essential reading for policy practitioners, researchers and students as well those with an interest in the future of public policy

At a time when neoliberal and conservative politics are again in the ascendency and social democracy is waning, Australian public policy re-engages with the values and goals of progressive public policy in Australia and the difficulties faced in re-affirming them. It brings together leading authors to explore economic, environmental, social, cultural, political and indigenous issues. It examines trends and current policy directions and outlines progressive alternatives that challenge and extend current thinking. While focused on Australia, the contributors offer valuable insights for people in other countries committed to social justice and those engaged in the ongoing contest between neo-liberalism and social democracy. This is essential reading for policy practitioners, researchers and students as well those with an interest in the future of public policy

Biobanks can have a pivotal role in elucidating disease etiology, translation, and advancing public health. However, meeting these challenges hinges on a critical shift in the way science is conducted and requires biobank harmonization. There is growing recognition that a common strategy is imperative to develop biobanking globally and effectively. To help guide this strategy, we articulate key principles, goals, and priorities underpinning a roadmap for global biobanking to accelerate health science, patient care, and public health. The need to manage and share very large amounts of data has driven innovations on many fronts. Although technological solutions are allowing biobanks to reach new levels of integration, increasingly powerful data-collection tools, analytical techniques, and the results they generate raise new ethical and legal issues and challenges, necessitating a reconsideration of previous policies, practices, and ethical norms. These manifold advances and the investments that support them are also fueling opportunities for biobanks to ultimately become integral parts of health-care systems in many countries. International harmonization to increase interoperability and sustainability are two strategic priorities for biobanking. Tackling these issues requires an environment favorably inclined toward scientific funding and equipped to address socio-ethical challenges. Cooperation and collaboration must extend beyond systems to enable the exchange of data and samples to strategic alliances between many organizations, including governmental bodies, funding agencies, public and private science enterprises, and other stakeholders, including patients. A common vision is required and we articulate the essential basis of such a vision herein.

Background: studies examining associations of early-life cat and dog ownership with childhood asthma have reported inconsistent results. Several factors could explain these inconsistencies, including type of pet, timing, and degree of exposure. Objective: our aim was to study associations of early-life cat and dog ownership with asthma in school-aged children, including the role of type (cat vs dog), timing (never, prenatal, or early childhood), and degree of ownership (number of pets owned), and the role of allergic sensitization. Methods: we used harmonized data from 77,434 mother-child dyads from 9 birth cohorts in the European Union Child Cohort Network when the child was 5 to 11 years old. Associations were examined through the DataSHIELD platform by using adjusted logistic regression models, which were fitted separately for each cohort and combined by using random effects meta-analysis. Results: the prevalence of early-life cat and dog ownership ranged from 12% to 45% and 7% to 47%, respectively, and the prevalence of asthma ranged from 2% to 20%. There was no overall association between either cat or dog ownership and asthma (odds ratio [OR] = 0.97 [95% CI = 0.87-1.09] and 0.92 [95% CI = 0.85-1.01], respectively). Timing and degree of ownership did not strongly influence associations. Cat and dog ownership were also not associated with cat- and dog-specific allergic sensitization (OR = 0.92 [95% CI = 0.75-1.13] and 0.93 [95% CI = 0.57-1.54], respectively). However, cat- and dog-specific allergic sensitization was strongly associated with school-age asthma (OR = 6.69 [95% CI = 4.91-9.10] and 5.98 [95% CI = 3.14-11.36], respectively). There was also some indication of an interaction between ownership and sensitization, suggesting that ownership may exacerbate the risks associated with pet-specific sensitization but offer some protection against asthma in the absence of sensitization. Conclusion: our findings do not support early-life cat and dog ownership in themselves increasing the risk of school-age ...