Recruitment, Retention, and Training of Citizen Scientists in Translational Medicine Research: A Citizen Science Initiative on Non-Alcoholic Fatty Liver Disease.

Citizen science is a participatory science approach in which members of the public (citizens) collaborate with scientists and professional researchers and become involved in research and innovation activities, resulting in the co-creation of scientific knowledge and innovation. Citizen science has been widely applied in research, particularly in the social sciences, environmental sciences, information and communication technologies, and public health. However, the application of this approach in clinical sciences, particularly in translational medicine research, is still nascent. This exploratory study involved members of the public (citizen scientists) in a translational medicine experiment on non-alcoholic fatty liver disease that incorporated a lifestyle and weight-loss intervention. The aim of this paper is to report successful methods and approaches for the recruitment, retention, and training of citizen scientists. For the citizen scientists' recruitment, online calls placed on the websites of our research project and biomedical research center and targeted emails were the most helpful. Of the 14 members of the public who expressed interest in our study, six were recruited as citizen scientists. Citizen scientists were mostly female (n = 5, 83%), white (n = 3, 50%), over 50 years of age (n = 4, 67%), educated to postgraduate level (n = 5, 83%), and either retired or not in employment (n = 5, 83%). The retention rate was 83% (n = 5), and the dropout rate was 17% (n = 1). We arranged instructor-led interactive online training sessions (an hour-long one-on-one session and two-hour group sessions). Research skills training covered ethics in research and qualitative and quantitative data analysis. Citizen scientists were given several incentives, such as reimbursement of travel and care costs, selection as citizen scientists of the month, publications of their blogs and perspective articles, and co-authorship and acknowledgement in papers and project deliverables. To conclude, members of the public (particularly middle-aged white women with postgraduate education) are interested in becoming citizen scientists in translational medicine research. Their retention rate is higher, and they can contribute to different research activities. However, they need training to develop their research skills and expertise. The training should be simple, comprehensive, and flexible to accommodate the schedules of individual citizen scientists. They deserve incentives as they work on a voluntary basis.

Perceptions of gender equity and markers of achievement in a National Institute for Health Research Biomedical Research Centre: a qualitative study.

BACKGROUND: The need to improve gender equity (GE) in academic medicine is well documented. Biomedical Research Centres (BRCs), partnerships between leading National Health Service (NHS) organizations and universities in England, conduct world-class translational research funded by the National Institute for Health and Care Research (NIHR). In 2011, eligibility for BRC funding was restricted to universities demonstrating sustained GE success recognized by the Athena SWAN Charter for Women in Science Silver awards. Despite this structural change, GE research in BRC settings is underdeveloped, yet critical to the acceleration of women's advancement and leadership. To explore both women's and men's perceptions of GE and current markers of achievement in a BRC setting. METHODS: Thematic analysis of data from two research projects: 53 GE survey respondents' free-text comments (34 women, 16 men), and 16 semi-structured interviews with women affiliated to the NIHR Oxford BRC. RESULTS: Four major themes emerged from the analysis: perceptions of the Athena SWAN Charter for Women in Science (GE policy); views on monitoring GE in BRCs; views on current markers of achievement in academia and GE; and recommendations for actions to improve GE in BRC settings. Monitoring of GE in BRCs was deemed to be important, but complex. Participants felt that current markers of achievement were not equitable to women, as they did not take contextual factors into account such as maternity leave and caring responsibilities. BRC-specific organizational policies and metrics are needed in order to monitor and catalyse GE. CONCLUSIONS: Markers of achievement for monitoring GE in BRCs should consider contextual factors specific to BRCs and women's career progression and professional advancement. GE markers of achievement should be complemented with broader aspects of equality, diversity and inclusion.

Translational researchers' training and development needs, preferences, and barriers: A survey in a National Institute for Health Research Biomedical Research Centre in the United Kingdom.

The objective was to identify translational researchers' training and development needs, preferences, and barriers to attending training. This cross-sectional study involved an online questionnaire survey. The research population comprised a convenience sample of translational researchers and support staff (N = 798) affiliated with the National Institute for Health Research Oxford Biomedical Research Centre. The response rate was 24%. Of 189 respondents, 114 were women (60%) and 75 were men (40%). The respondents were mainly research scientists (31%), medical doctors and dentists (17%), and research nurses and midwives (16%). Many of the respondents had attended at least one training course in the last year (68%). Training in statistics and data analysis was the most common training received (20%). Leadership training was the most wanted training (25%). Morning was the most preferred time of training (60%). Half a day was the ideal duration of a training course (41%). The main teaching hospital site was the most preferred location of training (46%). An interactive workshop was the most favored delivery style of training (52%). Most common barriers to attending training were the lack of time (31%), work (21%) and clinical commitments (19%), and family and childcare responsibilities (14%). Some differences in training needs, preferences, and barriers were found by gender and role, though these were not statistically significant. Translational researchers want short, easily accessible, and interactive training sessions during the working day. The training needs, preferences, and barriers to attending training need to be considered while developing inclusive training programs in biomedical research settings.

Rapid research response to the COVID-19 pandemic: perspectives from a National Institute for Health Biomedical Research Centre.

With over 5 million COVID-19 deaths at the time of writing, the response of research leaders was and is critical to developing treatments to control the global pandemic. As clinical research leaders urgently repurposed existing research programmes and resources towards the COVID-19 pandemic, there is an opportunity to reflect on practices observed in Biomedical Research Centre (BRC) settings. BRCs are partnerships between leading National Health Service organizations and universities in England conducting translational research for patient benefit funded by the National Institute for Health Research (NIHR). Oxford BRC-supported researchers have led the rapid set-up of numerous COVID-19 research studies at record speed with global impact. However, the specific contribution of BRCs to the COVID-19 pandemic in the literature is sparse. Firstly, we reflect on the strategic work of clinical research leaders, creating resilient NIHR research infrastructure to facilitate rapid COVID-19 research. Secondly, we discuss how COVID-19 rapid research exemplars supported by Oxford BRC illustrate "capacity", "readiness" and "capability" at an organizational and individual level to respond to the global pandemic. Rapid response research in turbulent environments requires strategic organizational leadership to create resilient infrastructure and resources. The rapid research exemplars from the Oxford BRC illustrate capability and capacity at an organizational and individual level in a dynamic environment to respond during the COVID-19 public health challenge. This response was underpinned by swift adaptation and repurposing of existing research resources and expertise by the Oxford BRC to deliver rapid research to address different aspects of COVID-19.

A large National Institute for Health Research (NIHR) Biomedical Research Centre facilitates impactful cross-disciplinary and collaborative translational research publications and research collaboration networks: a bibliometric evaluation study.

BACKGROUND: The evaluation of translational health research is important for various reasons such as the research impact assessment, research funding allocation, accountability, and strategic research policy formulation. The purpose of this study was to evaluate the research productivity, strength and diversity of research collaboration networks and impact of research supported by a large biomedical research centre in the United Kingdom (UK). METHODS: Bibliometric analysis of research publications by translational researchers affiliated with the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) from April 2012 to March 2017. RESULTS: Analysis included 2377 translational research publications that were published during the second 5-year funding period of the NIHR Oxford BRC. Author details were available for 99.75% of the publications with DOIs (2359 of 2365 with DOIs), and the number of authors per publication was median 9 (mean = 18.03, SD = 3.63, maximum = 2467 authors). Author lists also contained many consortia, groups, committees, and teams (n = 165 in total), with 1238 additional contributors, where membership was reported. The BRC co-authorship i.e., research collaboration network for these publications involved 20,229 nodes (authors, of which 1606 nodes had Oxford affiliations), and approximately 4.3 million edges (authorship linkages). Articles with a valid DOIs (2365 of 2377, 99.5%) were collectively cited more than 155,000 times and the average Field Citation Ratio was median 6.75 (geometric mean = 7.12) while the average Relative Citation Ratio was median 1.50 (geometric mean = 1.83) for the analysed publications. CONCLUSIONS: The NIHR Oxford BRC generated substantial translational research publications and facilitated a huge collaborative network of translational researchers working in complex structures and consortia, which shows success across the whole of this BRC funding period. Further research involving continued uptake of unique persistent identifiers and the tracking of other research outputs such as clinical innovations and patents would allow a more detailed understanding of large research enterprises such as NIHR BRCs in the UK.

Long-Term Conditions in Older People are Linked with Loneliness, but a Sense of Coherence Buffers the Adverse Effects on Quality of Life: A Cross-Sectional Study.

BACKGROUND: The impact of disability, long-term conditions, rurality, living alone, and being a carer on health has some evidence base, but the extent to which a strong sense of coherence (SoC), a factor hypothesised to promote wellbeing, may moderate these associations is unknown. A model of physical, environmental and social factors on quality of life was tested, with particular emphasis on whether a strong SoC buffered (mitigated) these determinants of quality of life. MATERIAL AND METHODS: A cross-sectional postal survey was undertaken of a random sample of 1471 respondents aged over 65 years, across a population of rural individuals. Physical, environmental, and psychological variables were assessed against quality of life using ANOVA and a generalised linear model including the interaction effects of SoC. RESULTS: ANOVA demonstrated that age, gender, long-term conditions or disability (LTC-D), living alone, >20 hours unpaid care for others per week, SoC, and loneliness, were associated with lower quality of life (p<0.01). There were strong correlations (p>0.01), between age and LTC-D, living alone, and poor SoC. Living alone was correlated with emotional and social loneliness; but those with higher SoC were less likely to experience loneliness. In an adjusted generalised linear model, significant associations with a lower quality of life were observed from: LTC-D, emotional loneliness and social loneliness (B= -0.44, -0.30, and -0.39, respectively, all p<0.001). The only interaction with SoC that was statistically significant (at p<0.05) was LTC-D. A stronger sense of coherence buffered the negative effects of long-term condition/disability on quality of life. DISCUSSION: The physical, environmental and social factors examined, identified LTC-D and loneliness to be the strongest factors associated with poor quality of life. CONCLUSION: SoC somewhat buffered the adverse effect of LTC-D on quality of life, but did not do so for loneliness.

Evaluation of the Effectiveness of Digital Technology Interventions to Reduce Loneliness in Older Adults: Systematic Review and Meta-analysis.

BACKGROUND: Loneliness is a serious public health issue, and its burden is increasing in many countries. Loneliness affects social, physical, and mental health, and it is associated with multimorbidity and premature mortality. In addition to social interventions, a range of digital technology interventions (DTIs) are being used to tackle loneliness. However, there is limited evidence on the effectiveness of DTIs in reducing loneliness, especially in adults. The effectiveness of DTIs in reducing loneliness needs to be systematically assessed. OBJECTIVE: The objective of this study is to assess the effectiveness of DTIs in reducing loneliness in older adults. METHODS: We conducted electronic searches in PubMed, MEDLINE, CINAHL, Embase, and Web of Science for empirical studies published in English from January 1, 2010, to July 31, 2019. The study selection criteria included interventional studies that used any type of DTIs to reduce loneliness in adults (aged ≥18 years) with a minimum intervention duration of 3 months and follow-up measurements at least 3 months after the intervention. Two researchers independently screened articles and extracted data using the PICO (participant, intervention, comparator, and outcome) framework. The primary outcome measure was loneliness. Loneliness scores in both the intervention and control groups at baseline and at follow-up at 3, 4, 6, and 12 months after the intervention were extracted. Data were analyzed via narrative synthesis and meta-analysis using RevMan (The Cochrane Collaboration) software. RESULTS: A total of 6 studies were selected from 4939 screened articles. These studies included 1 before and after study and 5 clinical trials (4 randomized clinical trials and 1 quasi-experimental study). All of these studies enrolled a total of 646 participants (men: n=154, 23.8%; women: n=427, 66.1%; no gender information: n=65, 10.1%) with an average age of 73-78 years (SD 6-11). Five clinical trials were included in the meta-analysis, and by using the random effects model, standardized mean differences (SMDs) were calculated for each trial and pooled across studies at the 3-, 4-, and 6-month follow-ups. The overall effect estimates showed no statistically significant difference in the effectiveness of DTIs compared with that of usual care or non-DTIs at follow-up at 3 months (SMD 0.02; 95% CI -0.36 to 0.40; P=.92), 4 months (SMD -1.11; 95% CI -2.60 to 0.38; P=.14), and 6 months (SMD -0.11; 95% CI -0.54 to 0.32; P=.61). The quality of evidence was very low to moderate in these trials. CONCLUSIONS: Our meta-analysis shows no evidence supporting the effectiveness of DTIs in reducing loneliness in older adults. Future research may consider randomized controlled trials with larger sample sizes and longer durations for both the interventions and follow-ups. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-032455.

Lessons from the pandemic on the value of research infrastructure.

The COVID-19 pandemic has shed a spotlight on the resilience of healthcare systems, and their ability to cope efficiently and effectively with unexpected crises. If we are to learn one economic lesson from the pandemic, arguably it is the perils of an overfocus on short-term allocative efficiency at the price of lack of capacity to deal with uncertain future challenges. In normal times, building spare capacity with 'option value' into health systems may seem inefficient, the costs potentially exceeding the benefits. Yet the fatal weakness of not doing so is that this can leave health systems highly constrained when dealing with unexpected, but ultimately inevitable, shocks-such as the COVID-19 pandemic. In this article, we argue that the pandemic has highlighted the potentially enormous option value of biomedical research infrastructure. We illustrate this with reference to COVID-19 response work supported by the United Kingdom National Institute for Health Research Oxford Biomedical Research Centre. As the world deals with the fallout from the most serious economic crisis since the Great Depression, pressure will soon come to review government expenditure, including research funding. Developing a framework to fully account for option value, and understanding the public appetite to pay for it, should allow us to be better prepared for the next emerging problem.

Gender parity in scientific authorship in a National Institute for Health Research Biomedical Research Centre: a bibliometric analysis.

OBJECTIVE: Scientific authorship is a vital marker of achievement in academic careers and gender equity is a key performance metric in research. However, there is little understanding of gender equity in publications in biomedical research centres funded by the National Institute for Health Research (NIHR). This study assesses the gender parity in scientific authorship of biomedical research. DESIGN: Descriptive, cross-sectional, retrospective bibliometric study. SETTING: NIHR Oxford Biomedical Research Centre (BRC). DATA: Data comprised 2409 publications that were either accepted or published between April 2012 and March 2017. The publications were classified as basic science studies, clinical studies (both trial and non-trial studies) and other studies (comments, editorials, systematic reviews, reviews, opinions, book chapters, meeting reports, guidelines and protocols). MAIN OUTCOME MEASURES: Gender of authors, defined as a binary variable comprising either male or female categories, in six authorship categories: first author, joint first authors, first corresponding author, joint corresponding authors, last author and joint last authors. RESULTS: Publications comprised 39% clinical research (n=939), 27% basic research (n=643) and 34% other types of research (n=827). The proportion of female authors as first author (41%), first corresponding authors (34%) and last author (23%) was statistically significantly lower than male authors in these authorship categories (p<0.001). Of total joint first authors (n=458), joint corresponding authors (n=169) and joint last authors (n=229), female only authors comprised statistically significant (p<0.001) smaller proportions, that is, 15% (n=69), 29% (n=49) and 10% (n=23) respectively, compared with male only authors in these joint authorship categories. There was a statistically significant association between gender of the last author with gender of the first author (p<0.001), first corresponding author (p<0.001) and joint last author (p<0.001). The mean journal impact factor (JIF) was statistically significantly higher when the first corresponding author was male compared with female (Mean JIF: 10.00 vs 8.77, p=0.020); however, the JIF was not statistically different when there were male and female authors as first authors and last authors. CONCLUSIONS: Although the proportion of female authors is significantly lower than the proportion of male authors in all six categories of authorship analysed, the proportions of male and female last authors are comparable to their respective proportions as principal investigators in the BRC. These findings suggest positive trends and the NIHR Oxford BRC doing very well in gender parity in the senior (last) authorship category. Male corresponding authors are more likely to publish articles in prestigious journals with high impact factor while both male and female authors at first and last authorship positions publish articles in equally prestigious journals.

Markers of achievement for assessing and monitoring gender equity in a UK National Institute for Health Research Biomedical Research Centre: A two-factor model.

BACKGROUND: The underrepresentation of women in academic medicine at senior level and in leadership positions is well documented. Biomedical Research Centres (BRC), partnerships between leading National Health Service (NHS) organisations and universities, conduct world class translational research funded by the National Institute for Health Research (NIHR) in the UK. Since 2011 BRCs are required to demonstrate significant progress in gender equity (GE) to be eligible to apply for funding. However, the evidence base for monitoring GE specifically in BRC settings is underdeveloped. This is the first survey tool designed to rank and identify new GE markers specific to the NIHR BRCs. METHODS: An online survey distributed to senior leadership, clinical and non-clinical researchers, trainees, administrative and other professionals affiliated to the NIHR Oxford BRC (N = 683). Participants ranked 13 markers of GE on a five point Likert scale by importance. Data were summarised using frequencies and descriptive statistics. Interrelationships between markers and underlying latent dimensions (factors) were determined by exploratory and confirmatory factor analyses. RESULTS: The response rate was 36% (243 respondents). Respondents were more frequently female (55%, n = 133), aged 41-50 years (33%, n = 81), investigators (33%, n = 81) affiliated to the BRC for 2-7 years (39.5%, n = 96). Overall participants ranked 'BRC senior leadership roles' and 'organisational policies on gender equity', to be the most important markers of GE. 58% (n = 141) and 57% (n = 139) respectively. Female participants ranked 'organisational policies' (64.7%, n = 86/133) and 'recruitment and retention' (60.9%, n = 81/133) most highly, whereas male participants ranked 'leadership development' (52.1%, n = 50/96) and 'BRC senior leadership roles' (50%, n = 48/96) as most important. Factor analyses identified two distinct latent dimensions: "organisational markers" and "individual markers" of GE in BRCs. CONCLUSIONS: A two-factor model of markers of achievement for GE with "organisational" and "individual" dimensions was identified. Implementation and sustainability of gender equity requires commitment at senior leadership and organisational policy level.

The COVID-19 Pandemic: A Pandemic of Lockdown Loneliness and the Role of Digital Technology.

The focus of this perspective is on lockdown loneliness, which we define as loneliness resulting from social disconnection as a result of enforced social distancing and lockdowns during the COVID-19 pandemic. We also explore the role of digital technology in tackling lockdown loneliness amid the pandemic. In this regard, we highlight and discuss a number of the key relevant issues: a description of lockdown loneliness, the burden of lockdown loneliness during the COVID-19 pandemic, characteristics of people who are more likely to be affected by lockdown loneliness, factors that could increase the risk of loneliness, lockdown loneliness as an important public health issue, tackling loneliness during the pandemic, digital technology tools for social connection and networking during the pandemic, assessment of digital technology tools from the end users' perspectives, and access to and use of digital technology for tackling lockdown loneliness during the COVID-19 pandemic. We suggest that the most disadvantaged and vulnerable people who are more prone to lockdown loneliness are provided with access to digital technology so that they can connect socially with their loved ones and others; this could reduce loneliness resulting from social distancing and lockdowns during the COVID-19 crisis. Nonetheless, some key issues such as access to and knowledge of digital technology tools must be considered. In addition, the involvement of all key stakeholders (family and friends, social care providers, and clinicians and health allied professionals) should be ensured.

Understanding the Athena SWAN award scheme for gender equality as a complex social intervention in a complex system: analysis of Silver award action plans in a comparative European perspective.

BACKGROUND: Given the complex mix of structural, cultural and institutional factors that produce barriers for women in science, an equally complex intervention is required to understand and address them. The Athena SWAN Award Scheme for Gender Equality has become a widespread means to address barriers for women's advancement and leadership in the United Kingdom, Ireland, Australia, the United States of America and Canada, while the European Commission is exploring the introduction of a similar award scheme across Europe. METHODS: This study analyses the design and implementation of 16 departmental Athena SWAN Silver Action Plans in Medical Sciences at one of the world's leading universities in Oxford, United Kingdom. Data pertaining to the design and implementation of gender equality interventions were extracted from the action plans, analysed thematically, coded using categories from the 2015 Athena SWAN Charter Awards Handbook and synthesised against a typology of gender equality interventions in the European Research Area. The results were further analysed against the complexity research literature framework, where research organisations are perceived as dynamic systems that adapt, interact and co-evolve with other systems. RESULTS: Athena SWAN is a complex contextually embedded system of action planning within the context of universities. It depends on a multitude of contextual variables that relate in complex, non-linear ways and dynamically adapt to constantly moving targets and new emergent conditions. Athena SWAN Silver Action Plans conform to the key considerations of complexity - (1) multiple actions and areas of intervention with a focus on the complex system being embedded in local dynamics, (2) the non-linearity of interventions and the constantly emerging conditions, and (3) impact in terms of contribution to change, improved conditions to foster change and the increased probability that change can occur. CONCLUSIONS: To enact effective sustainable structural and cultural change for gender equality, it is necessary to acknowledge and operationalise complexity as a frame of reference. Athena SWAN is the single most comprehensive and systemic gender equality scheme in Europe. It can be further strengthened by promoting the integration of sex and gender analysis in research and education. Gender equality policies in the wider European Research Area can benefit from exploring Athena SWAN's contextually embedded systemic approach to dynamic action planning and inclusive focus on all genders and categories of staff and students.

Effectiveness of digital technology interventions to reduce loneliness in adults: a protocol for a systematic review and meta-analysis.

INTRODUCTION: Loneliness is an emerging public health problem that is associated with social, emotional, mental and physical health issues. The application of digital technology (DT) interventions to reduce loneliness has significantly increased in the recent years. The effectiveness of DT interventions needs to be assessed systematically. METHODS AND ANALYSIS: Aim: To undertake a systematic review and meta-analysis on the effectiveness of DT interventions to reduce loneliness among adults. DESIGN: Systematic review and meta-analysis. DATA SOURCES: PubMed, Medline, CINAHL, EMBASE and Web of Science.Publication period: 1 January 2010 to 31 July 2019. INCLUSION CRITERIA: Primary studies involving the application of DT interventions to reduce loneliness, involving adult participants (aged ≥18 years), follow-up period ≥3 months and published in the English language.Synthesis and meta-analysis: A narrative summary of the characteristics of included studies, findings by the type of DT intervention, and the age, gender and ethnicity of participants. A meta-analysis by the study design and duration of follow-up and determination of random effects size using the RevMan V.5 software.Quality of evidence and bias: Quality of evidence assessed the RoB V.2.0 (revised tool for Risk of Bias in randomized trials) and ROBINS-I (Risk Of Bias in Non-randomized Studies-of Interventions) tools for randomised control trials and non-randomised studies, respectively. Heterogeneity between studies will be determined by the I2 and Cochran's Q statistics and publication bias checked with funnel plots and the Egger's test. ETHICS AND DISSEMINATION: Ethics approval was not required for this protocol. The findings will be disseminated through journal articles and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42019131524.

Correction: A macroeconomic assessment of the impact of medical research expenditure: A case study of NIHR Biomedical Research Centres.

[This corrects the article DOI: 10.1371/journal.pone.0214361.].

A macroeconomic assessment of the impact of medical research expenditure: A case study of NIHR Biomedical Research Centres.

Quantifying the value of investment in medical research can inform decision-making on the prioritisation of research programmes. Existing methodologies to estimate the rate of return of medical research are inappropriate for early-phase translational research due to censoring of health benefits and time lags. A strategy to improve the process of translational research for patient benefit has been initiated as part of the UK National Institute for Health Research (NIHR) investment in Biomedical Research Centres (BRCs) in England. By providing a platform for partnership between universities, NHS trusts and industry, successful BRCs should reduce time lags within translational research whilst also providing an impetus for local economic growth through industry collaboration. We present a novel contribution in the assessment of early-phase biomedical research by estimating the impact of the Oxford Biomedical Research Centre (OxBRC) on income and job creation following the initial NIHR investment. We adopt a macroeconomic assessment approach using Input-Output Analysis to estimate the value of medical research in terms of income and job creation during the early pathway towards translational biomedical research. Inter-industry linkages are assessed by building a model economy for the South East England region to estimate the return on investment of the OxBRC. The results from the input-output model estimate that the return on investment in biomedical research within the OxBRC is 46%. Each £1 invested in the OxBRC generates an additional £0.46 through income and job creation alone. Multiplicative employment effects following a marginal investment in the OxBRC of £98m during the period 2007-2017 result in an estimated additional 196 full time equivalent positions being created within the local economy on top of direct employment within OxBRC. Results from input-output analyses can be used to inform the prioritisation of biomedical research programmes when compared against national minimum thresholds of investment.

Structural Transformation to Attain Responsible BIOSciences (STARBIOS2): Protocol for a Horizon 2020 Funded European Multicenter Project to Promote Responsible Research and Innovation.

BACKGROUND: Promoting Responsible Research and Innovation (RRI) is a major strategy of the "Science with and for Society" work program of the European Union's Horizon 2020 Framework Programme for Research and Innovation. RRI aims to achieve a better alignment of research and innovation with the values, needs, and expectations of society. The RRI strategy includes the "keys" of public engagement, open access, gender, ethics, and science education. The Structural Transformation to Attain Responsible BIOSciences (STARBIOS2) project promotes RRI in 6 European research institutions and universities from Bulgaria, Germany, Italy, Slovenia, Poland, and the United Kingdom, in partnership with a further 6 institutions from Brazil, Denmark, Italy, South Africa, Sweden, and the United States. OBJECTIVE: The project aims to attain RRI structural change in 6 European institutions by implementing action plans (APs) and developing APs for 3 non-European institutions active in the field of biosciences; use the implementation of APs as a learning process with a view to developing a set of guidelines on the implementation of RRI; and develop a sustainable model for RRI in biosciences. METHODS: The project comprises interrelated research and implementation designed to achieve the aforementioned specific objectives. The project is organized into 6 core work packages and 5 supporting work packages. The core work packages deal with the implementation of institutional APs in 6 European institutions based on the structural change activation model. The supporting work packages include technical assistance, learning process on RRI-oriented structural change, monitoring and assessment, communication and dissemination, and project management. RESULTS: The project is funded by Horizon 2020 and will run for 4 years (May 2016-April 2020). As of June 2018, the initial phase has been completed. The participating institutions have developed and approved APs and commenced their implementation. An observation tool has been launched by the Technical Assistance Team to collect information from the implementation of APs; the Evaluation & Assessment team has started monitoring the advancement of the project. As part of the communication and dissemination strategy, a project website, a Facebook page, and a Twitter account have been launched and are updated periodically. The International Scientific Advisory Committee has been formed to advise on the reporting and dissemination of the project's results. CONCLUSIONS: In the short term, we anticipate that the project will have a considerable impact on the organizational processes and structures, improving the RRI uptake in the participating institutions. In the medium term, we expect to make RRI-oriented organizational change scalable across Europe by developing guidelines on RRI implementation and an RRI model in biosciences. In the long term, we expect that the project would help increase the ability of research institutions to make discoveries and innovations in better alignment with societal needs and values. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11745.

Demonstration of a Fair Level of Agreement Between Escalation Scores Reported by Hospital Managers and Analysis of Stress-Related Hospital Metrics.

BACKGROUND: The National Health System in Wales has developed a novel national electronic dashboard which reports a daily "escalation score," reflecting management's opinion of the pressure each hospital is facing, primarily due to unscheduled care. The aim of this study was to examine the possibility of replacing human scores with a quantitative model, based on the relationship between reported escalation scores and selected hospital metrics. METHODS: Generalized linear mixed models were used to model the association between hospital metrics and escalation scores between October one year and October the next year utilizing hospital bed occupancy rate, ambulance hours lost waiting outside emergency departments, number of "boarded out" patients in the hospital, and the daily ratio of admissions to discharges in the hospital. These models were tested against a subsequent period (December unto May the following year), using three models: "general," "hospital-specific," and "group-specific." The model generated by the initial time frame was tested against data from the subsequent time frame using weighted κ. RESULTS: Across 16 hospitals, using 3343 escalation scores, the rates of agreement and weighted κ were: general model (48.8%; 0.16), hospital-specific model (45.0%; 0.25), and group-specific model (43.1%; 0.25). A 17th small hospital was excluded due to missing data. CONCLUSIONS: This is novel research as no similar studies were identified, although the topic is important as it addresses a major current health-care challenge. Automated scores can be derived which have the advantage of being derived objectively, avoiding human inter- and intraindividual variation. Prospective testing is recommended to assess potential service planning benefit.

An examination of user costs in relation to smokers using a cessation service based in the UK.

BACKGROUND: Smoking cessation services provide support to smokers who desire to quit. Published studies to date have looked at the cost and benefit of service provision but typically focus on clinical trial data. Using routinely collected observational data, this study examined the costs involved in providing a service in terms of average health care expenditure per successful quit attempt in addition to population - level cost-effectiveness measures. METHODS: Data were analysed from Quit-51 smoking cessation service across five English regions between March 2013 and March 2016 (n = 9116). For each user, costs were estimated in relation to: (i) time spent with advisers; (ii) prescription of pharmacotherapy. The total costs compared against self-reported quit at 12 weeks, which represents the time period for which the service is offered. Cost per quit (CPQ), with 95% confidence interval (CI), was calculated by relating total expenditure to the number of quitters, firstly for the whole dataset and then by subgroups of key categorical variables, namely; gender, age group, the Fagerstrom test for nicotine dependence (FTND) and Index of Multiple Deprivation (IMD). Confidence intervals (CIs) for the mean estimates were derived using a non-parametric bootstrap procedure. Parameters derived from the calculation in relation to treatment were used to estimate potential long-term population outcomes under a scenario where the Quit 51 prescription was rolled out nationally. RESULTS: The overall mean CPQ for this sample as estimated at 12 weeks was £403.51 (95% CI = £393.36 to £413.76). The estimated CPQs at this time point were comparable for those aged 12-19 (£423.56, 95% CI = £369.45 to £492.60) and those aged 20-29 (£430.76, 95% CI = £395.95 to £470.56). Differences were also seen in relation to other subgroups considered. The treatment parameters translated to a projected increase of 1.5 quality-adjusted life years (QALYs) per 1000 smokers in the short-term and 23.4 QALYS per 1000 smokers based on a lifetime horizon. CONCLUSIONS: These figures throw light on service expenditure for each successful quit over the timeframe for which the service is offered in addition to highlighting variability in these costs across different subgroups of the user population.

Factors moderating the relative effectiveness of varenicline and nicotine replacement therapy in clients using smoking cessation services.

AIMS: To assess how far the greater effectiveness of varenicline over nicotine replacement therapy (NRT) is moderated by characteristics of the smokers or setting in clinical practice. DESIGN: We used observational data from 22 472 treatment episodes between 2013 and 2016 from smoking cessation services in England to assess whether differences between varenicline and NRT were moderated by a set of smoker and setting characteristics: these included level of social deprivation, age, gender, ethnic group, nicotine dependence and treatment context. From the above, 15 640 episodes were analysed in relation to 4-week quit and 14 273 episodes at 12 weeks. All two-way interactions involving pharmacotherapy were fitted in addition to the main effects and a parsimonious model identified using a backwards stepwise selection procedure. SETTING: England PARTICIPANTS: Clients of smoking cessation service (number of individuals in 4-week quit analysis = 15 640). MEASUREMENTS: Four-week carbon monoxide-validated (primary outcome) and 12-week self-reported (secondary outcome) quit success/failure. FINDINGS: At both follow-up points, varenicline was associated with higher success rates overall [P < 0.001 at both 4 and 12 weeks; adjusted odds ratio (OR) varenicline versus NRT = 1.82 (95% confidence interval (CI) = 1.61, 2.06) and 2.58 (95% CI = 2.26, 2.94) at 4 and 12 weeks, respectively]. At 12 weeks, the relative benefits of varenicline were found to be influenced by the setting in which advice was provided [P < 0.001 for interaction pharmacotherapy × setting; adjusted odds ratio for varenicline × pharmacy setting = 0.53 (95% CI = 0.42, 0.69) and for varenicline × general practice (GP) setting = 0.79 (95% CI = 0.64, 0.98) against a baseline of 1 for varenicline × community setting]. The same trends were evident at 4 weeks, but this did not translate to statistical significance. There was inconclusive evidence for moderating effects of other variables. CONCLUSIONS: Varenicline use was associated with higher smoking cessation rates than nicotine replacement therapy in routine clinical practice, irrespective of a wide range of smoker characteristics, but the difference was less in certain intervention settings, most notably pharmacy but also GP practice, compared with community setting.

Maximising value from a United Kingdom Biomedical Research Centre: study protocol.

BACKGROUND: Biomedical Research Centres (BRCs) are partnerships between healthcare organisations and universities in England. Their mission is to generate novel treatments, technologies, diagnostics and other interventions that increase the country's international competitiveness, to rapidly translate these innovations into benefits for patients, and to improve efficiency and reduce waste in healthcare. As NIHR Oxford BRC (Oxford BRC) enters its third 5-year funding period, we seek to (1) apply the evidence base on how best to support the various partnerships in this large, multi-stakeholder research system and (2) research how these partnerships play out in a new, ambitious programme of translational research. METHODS: Organisational case study, informed by the principles of action research. A cross-cutting theme, 'Partnerships for Health, Wealth and Innovation' has been established with multiple sub-themes (drug development, device development, business support and commercialisation, research methodology and statistics, health economics, bioethics, patient and public involvement and engagement, knowledge translation, and education and training) to support individual BRC research themes and generate cross-theme learning. The 'Partnerships' theme will support the BRC's goals by facilitating six types of partnership (with patients and citizens, clinical services, industry, across the NIHR infrastructure, across academic disciplines, and with policymakers and payers) through a range of engagement platforms and activities. We will develop a longitudinal progress narrative centred around exemplar case studies, and apply theoretical models from innovation studies (Triple Helix), sociology of science (Mode 2 knowledge production) and business studies (Value Co-creation). Data sources will be the empirical research studies within individual BRC research themes (who will apply separately for NHS ethics approval), plus documentary analysis and interviews and ethnography with research stakeholders. This study has received ethics clearance through the University of Oxford Central University Research Ethics Committee. DISCUSSION: We anticipate that this work will add significant value to Oxford BRC. We predict accelerated knowledge translation; closer alignment of the innovation process with patient priorities and the principles of responsible, ethical research; reduction in research waste; new knowledge about the governance and activities of multi-stakeholder research partnerships and the contexts in which they operate; and capacity-building that reflects the future needs of a rapidly-evolving health research system.