Broad Group Of Stakeholders Research Articles

“It’s easier to take a pill than fix a problem:” qualitative analysis of barriers and facilitators to antimicrobial stewardship program implementation in carceral settings

BackgroundWidespread antibiotic prescribing contributes to globally emerging antimicrobial resistance (AMR). Despite stewardship recommendations by the Infectious Diseases Society of America, there is a lack of literature identifying barriers and facilitators to antimicrobial stewardship programs (ASPs) in United States (U.S.) carceral settings.MethodsGuided by the Theoretic Domains Framework, we performed in-depth interviews with 68 key stakeholders in Massachusetts carceral settings to contextualize barriers and facilitators to ASP implementation. We recruited 32 people incarcerated in Massachusetts jails and 36 carceral clinicians, correctional officers/administrators in Massachusetts and other U.S. states, and Massachusetts community clinicians for interviews.ResultsFrom the completed semi-structured in-depth interviews, we identified seven salient themes—four barriers and three facilitators—both specific to and across stakeholder groups. Barriers included the following: (1) jail being viewed as a “dirty place” that increases the risk of infections; (2) variable awareness and knowledge of AMR and ASPs; (3) clinicians’ opposition to change and oversight of their antibiotic prescribing; (4) competing priorities taking precedence over ASP implementation. Facilitators included (5) interest in changing the narrative about carceral healthcare through ASP implementation; (6) opportunities for education about ASP and AMR; and (7) the development of systems, policies, and regulations to improve antibiotic prescribing.ConclusionsTo our knowledge, this is the first qualitative study to leverage broad criminal-legal stakeholder groups to inform the next steps in developing and implementing ASPs in carceral settings in the U.S.

Measles outbreak in 2019: a warning for the post-COVID-19 pandemic period.

Introduction. At the end of 2019 and the year before, there was a significant spread of measles in the World Health Organization (WHO) European Region.Gap statement. Among the countries that reported, a measles outbreak was Bosnia and Herzegovina (BiH).Aim. To describe the measles outbreak in BiH (an entity of the Federation of BiH, FBiH) in 2019.Methodology. Confirmatory IgM serology, measles nucleic acid detection by real-time RT-PCR and virus genotyping were done in the WHO-accredited laboratory for measles and rubella at the Clinical Center of the University of Sarajevo, Unit for Clinical Microbiology. Genotype was determined in all measles-RNA-positive cases by sequence analysis of the 450 nt fragment coding the C-terminal of measles virus nucleoprotein (N).Results. From 1 January to 31 December 2019, 1332 measles cases were reported, with the peak observed in April 2019 (413/1332, 31.01 %). Sarajevo Canton had the highest incidence, number of cases and percentage (206.4; 868/1332; 65.17 %) of measles cases. Around four-fifths of infected persons were unvaccinated (1086/1332, 81.53 %), while 4.58 % of the patients (61/1332) were immunized with one dose of measles-containing vaccine. The highest proportion of cases was found in children 0-6 years of age (738/1332, 55.41 %). Measles IgM positivity was determined in 75.88 % (346/456), while virus RNA was detected in 82.46 % (47/57) of the swab samples. All measles virus sequences belonged to genotype B3. SNP (position 216: C=>T) was detected in 1 of the 40 sequences obtained during this outbreak.Conclusion. Due to suboptimal immunization coverage, BiH belongs to countries at a high risk for measles outbreaks. Post-COVID-19 (coronavirus disease 2019) pandemic, targeted and tailored strategies are required to ensure routine vaccination demand and acceptance and broad partner and stakeholder group participation.

Digitalization of toxicology: improving preclinical to clinical translation.

Though the portfolio of medicines that are extending and improving the lives of patients continues to grow, drug discovery and development remains a challenging business on its best day. Safety liabilities are a significant contributor to development attrition where the costliest liabilities to both drug developers and patients emerge in late development or post-marketing. Animal studies are an important and influential contributor to the current drug discovery and development paradigm intending to provide evidence that a novel drug candidate can be used safely and effectively in human volunteers and patients. However, translational gaps-such as toxicity in patients not predicted by animal studies-have prompted efforts to improve their effectiveness, especially in safety assessment. More holistic monitoring and "digitalization" of animal studies has the potential to enrich study outcomes leading to datasets that are more computationally accessible, translationally relevant, replicable, and technically efficient. Continuous monitoring of animal behavior and physiology enables longitudinal assessment of drug effects, detection of effects during the animal's sleep and wake cycles and the opportunity to detect health or welfare events earlier. Automated measures can also mitigate human biases and reduce subjectivity. Reinventing a conservative, standardized, and traditional paradigm like drug safety assessment requires the collaboration and contributions of a broad and multi-disciplinary stakeholder group. In this perspective, we review the current state of the field and discuss opportunities to improve current approaches by more fully leveraging the power of sensor technologies, artificial intelligence (AI), and animal behavior in a home cage environment.

Developing Guidance for Donor Intervention Randomized Controlled Trials: Initial Discussions From the Canada-United Kingdom 2022 Workshop.

Donor interventions, including medications, protocols, and medical devices administered to donors, can enhance transplantable organ quality and quantity and maximize transplantation success. However, there is paucity of high-quality evidence about their effectiveness, in part because of ethical, practical, and regulatory challenges, and lack of guidance about conduct of donor intervention randomized controlled trials (RCTs). With the vision to develop authoritative guidance for conduct of donor intervention RCTs, we convened a workshop of Canadian-United Kingdom experts in organ donation and transplantation ethics, research, and policy to identify stakeholders, explore unique challenges, and develop research agenda to inform future work in this promising field. Donor intervention trials should consider perspectives of broad group of stakeholders including donors, transplant recipients, and their families; researchers in donation and transplantation; research ethics boards; and healthcare providers and administrators involved in donation and transplantation. Unique challenges include (1) research ethics (living versus deceased status of the donor at the time of intervention, intervention versus outcomes assessment in different individuals, harm-benefit analysis in donors versus recipients, consent, and impact on research bystanders); (2) outcome data standardization and linkage; and (3) regulatory and governance considerations. Donor intervention RCTs hold potential to benefit organ transplantation outcomes but face unique research ethics, outcome data, and regulatory challenges. By developing research agenda to address these challenges, our workshop was an important first step toward developing Canada-United Kingdom guidance for donor intervention RCTs that are poised to improve the quality and availability of transplantable organs.

Marine Stewardship Council’s Fisheries Standard: Updated best practices for promoting sustainable seafood

Eco-labeling can incentivize effective management to sustain productive fisheries, but certification standards occasionally need to be updated to reflect iterative advancement in marine policy. The Marine Stewardship Council (MSC) recently developed a revised standard for fishery certification, and the process provides case studies in policy development that are compiled in this special issue. Consultation with a broad group of international stakeholders identified several aspects of the MSC standard that required re-evaluation. Standards, expressed as performance indictors and scoring criteria, were revised based on current perceptions of best practices in fishery management. The revised standard requires greater evidence of management performance, more rigorous protection of endangered species and vulnerable habitats, more comprehensive mitigation of ghost fishing, explicit harvest strategies, more effective exclusion of shark finning, and socioeconomic performance indicators. Although the implementation of certification standards will continue to be imperfect, the process and results from MSC’s standard review offer methods and case studies for broader application to codify best practices in marine policy as they continually evolve.

Exploring the safety and quality of mobile X-ray imaging in a new infectious disease biocontainment unit: an in situ simulation and video-reflexive study

ObjectivesDuring a precommissioning inspection of a new biocontainment centre, radiographers noted structural features of quarantine rooms that could compromise staff and patient safety and the X-ray image quality, even after...

Accelerating Light-Duty Fleet Decarbonisation through Energy Efficiency Audits: Results and Methodology Assessment

The transport sector is responsible for 37% of the energy consumption in Portugal (70% of it due to road transportation), supplied almost completely by fossil fuels. Portugal must reduce these sector’s emissions by 98% to achieve carbon neutrality by 2050, thus making transportation a crucial sector for a successful decarbonisation of the economy. This scenario sparked action at ADENE – the Portuguese Energy Agency to create MOVE+, an auditing methodology that incentivises and guides a broad group of stakeholders to act on the decarbonisation of mobility, starting with light duty and freight fleets. It comprises a framework to rate fleets on energy efficiency which enables regular implementation and monitoring of decarbonisation measures in areas such as vehicle technology, telematics, driver training, tyre selection, and maintenance. This paper shows that the application of the MOVE+ methodology helped identify an electrification potential of 24% on average per fleet, according to the Best-in-Class (whereas the analysed sample shows 20% of electrification). A multiple linear regression model validates the correlation between MOVE+ obtained scores, in the evaluated dimensions, and the fleet’s specific CO2 emissions. The methodology also allows us to assess that Portugal is lagging to meet the carbon neutrality target for the transport sector by 2050. Such assessment allows us to estimate that, regarding light-duty fleets, at the current pace zero emissions will only be reached by 2080, thus highlighting the need for public policy adjustments that push towards faster decarbonisation.

Grading of recommendations, assessment, development and evaluations concept 7: issues and insights linking guideline recommendations to trustworthy essential medicine lists

ObjectivesGuidelines and essential medicine lists (EMLs) bear similarities and differences in the process that lead to decisions. Access to essential medicines is central to achieve universal health coverage. The World Health Organization (WHO) EML has guided prioritization of essential medicines globally for nearly 50 years, and national EMLs (NEMLs) exist in over 130 countries. Guideline and EML decisions, at WHO or national levels, are not always coordinated and aligned. We sought to explore challenges, and potential solutions, for decision-making to support trustworthy medicine selection for EMLs from a Grading of Recommendations, Assessment, Development and Evaluations (GRADE) Working Group perspective. We primarily focus on the WHO EML; however, our findings may be applicable to NEML decisions as well. Study Design and SettingWe identified key challenges in connecting the EML to health guidelines by involving a broad group of stakeholders and assessing case studies including real applications to the WHO EML, South Africa NEML, and a multiple sclerosis guideline connected to a WHO EML application for multiple sclerosis treatments. To address challenges, we utilized the results of a survey and feedback from the stakeholders, and iteratively met as a project group. We drafted a conceptual framework of challenges and potential solutions. We presented a summary of the results for feedback to all attendees of the GRADE Working Group meetings in November 2022 (approximately 120 people) and in May 2023 (approximately 100 people) before finalizing the framework. ResultsWe prioritized issues and insights/solutions that addressed the connections between the EML and health guidelines. Our suggested solutions include early planning alignment of guideline groups and EMLs, considering shared participation to strengthen linkage, further clarity on price/cost considerations, and using explicit shared criteria to make guideline and EML decisions. We also provide recommendations to strengthen the connection between WHO EML and NEMLs including through contextualization methods. ConclusionThis GRADE concept article, jointly developed by key stakeholders from the guidelines and EMLs field, identified key conceptual issues and potential solutions to support the continued advancement of trustworthy EMLs. Adopting structured decision criteria that can be linked to guideline recommendations bears the potential to advance health equity and gaps in availability of essential medicines within and between countries.

Action for Health and Equity, Addressing medical Deserts (AHEAD)

Abstract The Project AHEAD (Action for Health and Equity, Addressing medical Deserts) aims to support policy makers in their health workforce reforms targeting medical deserts: ‘the end point of a complex ‘medical desertification’ process, that implies continuous and increasing inability of a given population to access health services in a timely and contextually relevant manner’. The AHEAD project is carried out in Italy, Moldova, the Netherlands, Romania and Serbia, highlighting different manifestations of medical deserts. AHEAD features two unique selling points: a medical deserts diagnostic tool (MDDT) and a consensus building methodology. 1. The MDDT intends to support policy makers in identifying and monitoring medical deserts (and areas at risk), by visualising health worker and health services densities, at disaggregated level, on interactive maps. Evaluation findings indicate great interest for this tool among policy makers, as well as challenges in data availability. 2. The Consensus Building (CB) Methodology brings together a broad group of stakeholders playing a role in, or affected by, medical desertification. During a series of interactive workshops, they jointly explore causes and effects of medical desertification, exchange experiences, and develop feasible and context-specific policy solutions. These policy solutions are subsequently discussed during national policy dialogues, where commitments are made by the various actors and duty bearers to implement them. Evaluation findings acknowledge the added value of this participatory, multi-stakeholder approach. Because the policy options are context-specific, policy dialogues yielded a wide variety of policy solutions. However, several common themes emerged relating to the variety of actors needed at the tables, the importance of their different and complementary mandates, and the need to address related power dynamics.

Harnessing Systems Science and Co-Creation Techniques to Develop a Theory of Change towards Sustainable Transport

Integrated transport and land-use planning and reduced car dependency proffers a pathway to mobility justice and reduced transport poverty, whilst providing opportunities for potential health benefits and reducing carbon emissions. In spite of this, smaller cities and towns face opposition to the reallocation of road space away from the private car. Traditionally, transport measures have been responsive to growing car-use. To accelerate a behavioural shift to sustainable modes, an evidence-based, transformative approach is required that is consultative in nature, and inclusive of all relevant stakeholders and nurtures innovation. The study aims to achieve this by co-creating a theory of change, with a broad group of stakeholders and the community. Systems science and co-creation techniques were utilised to enable informed decision-making and foster shared learning, resulting in a theory of change formulated by stakeholders with a shared vision. Sixteen objectives were identified under five broad categories, create sustainable systems; design healthy built environments; engage society; empower people and prioritise road safety, informed by the systems-based framework Global Action Plan on Physical Activity. Assumptions, risks and key performance indicators were key elements of the theory of change. Risks identified for successful implementation of the plan were lack of funding and human resources to deliver actions, political challenges, lengthy planning processes, entrenched social norms and resistance from the community. This process, which was adopted, synthesises scientific evidence, a participatory systems approach, informed decision making and the practical application of the embedded researcher, resulting in a pragmatic theory of change to reduce car-dependency and create a shift to sustainable travel modes. The process highlights the importance of stakeholder and community engagement, from participatory mapping of the system to the development of the theory of change to generate local solutions to identified challenges. The resulting theory of change will form the basis of a Sustainable Urban Mobility Plan for Kilkenny City. The theory of change can be adapted to new settings by the participatory processes outlined.

Establishing a stakeholder group for primary care focused cancer research in Ireland

Introduction: Currently, no group specifically supports and coordinates primary care focused cancer research in Ireland. The aim of this project is to establish an inclusive stakeholder group for primary care focused cancer research in Ireland, to coordinate research efforts and build capacity in researchers and institutions. Methods: We will convene a stakeholder group, recruiting individuals with personal and professional experience of cancer care in a community setting. “Core stakeholders”—patients, clinicians, researchers, and policymakers—will attend regularly. Additional “specialist stakeholders”, such as representatives of secondary care, private healthcare, health insurance, industry, cancer charities, and health research funders, will participate on an ad hoc basis. An e-Delphi consensus process will be used to assess the stakeholders’ views on: (1) the relevance and importance of primary care focused cancer research; (2) the potential role and scope of the stakeholder group; (3) how best to engage with lived experience stakeholders and healthcare professionals affected by the research; (4) how best to disseminate results and advocate for translation of findings into practice. Round 1 will be open-ended and will invite the independent suggestions of stakeholders; in Round 2 and 3, group members will vote on the inclusion of these suggestions in a position statement by the group, with consensus defined as ≥75% agreement. Discussion: The formation of a broad stakeholder group to support primary care focused cancer research will ensure research is relevant, patient centered, and more readily translated into practice. It is also hoped that the group will support capacity building and strategic planning in this important research space.

The All of Us Data and Research Center: Creating a Secure, Scalable, and Sustainable Ecosystem for Biomedical Research.

The All of Us Research Program's Data and Research Center (DRC) was established to help acquire, curate, and provide access to one of the world's largest and most diverse datasets for precision medicine research. Already, over 500,000 participants are enrolled in All of Us, 80% of whom are underrepresented in biomedical research, and data are being analyzed by a community of over 2,300 researchers. The DRC created this thriving data ecosystem by collaborating with engaged participants, innovative program partners, and empowered researchers. In this review, we first describe how the DRC is organized to meet the needs of this broad group of stakeholders. We then outline guiding principles, common challenges, and innovative approaches used to build the All of Us data ecosystem. Finally, we share lessons learned to help others navigate important decisions and trade-offs in building a modern biomedical data platform.

Knowledge coproduction on the impact of decisions for waterbird habitat in a changing climate.

Scientists, resource managers, and decision makers increasingly use knowledge coproduction to guide the stewardship of future landscapes under climate change. This process was applied in the California Central Valley (USA) to solve complex conservation problems, where managed wetlands and croplands are flooded between fall and spring to support some of the largest concentrations of shorebirds and waterfowl in the world. We coproduced scenario narratives, spatially explicit flooded waterbird habitat models, data products, and new knowledge about climate adaptation potential. We documented our coproduction process, and using the coproduced models, we determined when and where management actions make a difference and when climate overrides these actions. The outcomes of this process provide lessons learned on how to cocreate usable information and how to increase climate adaptive capacity in a highly managed landscape. Actions to restore wetlands and prioritize their water supply created habitat outcomes resilient to climate change impacts particularly in March, when habitat was most limited; land protection combined with management can increase the ecosystem's resilience to climate change; and uptake and use of this information was influenced by the roles of different stakeholders, rapidly changing water policies, discrepancies in decision-making time frames, and immediate crises of extreme drought. Although a broad stakeholder group contributed knowledge to scenario narratives and model development, to coproduce usable information, data products were tailored to a small set of decision contexts, leading to fewer stakeholder participants over time. A boundary organization convened stakeholders across a large landscape, and early adopters helped build legitimacy. Yet, broadscale use of climate adaptation knowledge depends on state and local policies, engagement with decision makers that have legislative and budgetary authority, and the capacity to fit data products to specific decision needs.

Critical reflections on sustainability reporting standard setting

PurposeThe aim of this paper is to provide critical reflections on the role of standard setters and the endeavours of various organisations to provide sustainability reporting standards.Design/methodology/approachThe authors’ critical reflections are informed by the literature and websites of IASB, International Sustainability Standards Board (ISSB), global reporting initiative (GRI) and other relevant organisations. The authors use Bourdieu’s concept of field to support their analysis and critique.FindingsThe authors highlight how a disrupted standard-setting field will be a distraction from efforts to address real sustainability issues and concerns. Determining the “legitimate” sustainability reporting standards is likely to be an outcome of struggles between occupants in the sustainability standard-setting field. Accordingly, the shape of legitimate standards will be defined by those with power. The concern is the priority and the motive underpinning the endeavours of those with power. The authors propose that it is important for both the ISSB and GRI to serve the interest of a broad range of actors, including those who are not likely to have a say in sustainability reporting standard setting.Practical implicationsThis paper contributes to sustainability reporting practice by putting forward a case for strengthening current sustainability reporting practices with appropriate changes to overcome some of the criticisms of the GRI.Social implicationsThe authors highlight that there is a much broader group of stakeholders who require sustainability information and that it is important that the sustainability reporting standards serve the information needs of all stakeholders and not just those of the dominant actors. However, the ISSB with its economic focus will inevitably focus on the concern of investors and market participants.Originality/valueThe originality in this paper is the use of Bourdieu’s concept of field to theoretically highlight how a new standard setter may disrupt the sustainability standard-setting field and act as a distraction from efforts to address sustainability issues and concerns that the world faces.

Points to consider: EULAR–UEMS standards for the training of European rheumatologists

BackgroundPostgraduate rheumatology training programmes are already established at a national level in most European countries. However, previous work has highlighted a substantial level of heterogeneity in the organisation and, in...

"To Be Honest, You Probably Would Have to Read It 50 Times": Stakeholders Views on Using the Opt-Out Approach for Vaccination in Jails.

Despite national guidelines on infectious disease testing and vaccination in prisons, there is heterogeneity on the implementation of these practices in jails. We sought to better understand perspectives on the implementation of opt-out vaccination for infectious diseases in jails by interviewing a broad group of stakeholders involved in infectious diseases vaccination, testing, and treatment in Massachusetts jails. The research team conducted semistructured interviews with people incarcerated in Hampden County Jail (Ludlow, Massachusetts), clinicians working in jail and community settings, corrections administrators, and representatives from public health, government, and industry between July 2021 and March 2022. Forty-eight people were interviewed, including 13 people incarcerated at the time of interview. Themes that emerged included the following: misunderstandings of what opt-out means, indifference to the way vaccines are offered, belief that using the opt-out approach will increase the number of individuals who receive vaccination, and that opt-out provides an easy way for vaccine rejection and reluctance to accept vaccination. There was a clear divide in stakeholders' support of the opt-out approach, which was more universally supported by those who work outside of jails compared to those who work within or are incarcerated in jails. Compiling the perspectives of stakeholders inside and outside of jail settings on the opt-out approach to vaccination is the first step to develop feasible and effective strategies for implementing new health policies in jail settings.

Involving stakeholders in scenario-building: Lessons from a case study of the global context of Norway’s climate policies

This paper assesses the relevance and outcome of involving a transdisciplinary group of stakeholders in a scenario-building research project. The scenarios describe plausible external, long-term conditions with the aim to improve the knowledge basis of a national (Norwegian) government pursuing climate policy targets for 2030 and 2050 under uncertainty. The scenario process has two phases with quite different roles for the participants. In the first, the aim is to create broad engagement and participation in exploring narratives for how key external conditions might develop and form premises for the national climate strategies for Norway. The ambition in this phase is to deduce a handful of wide-ranging and distinctly different, qualitative scenarios. The second phase is devoted to translating the narratives into quantitative projections for the Norwegian economy and greenhouse gas emissions by means of linking global and national largescale models. We claim that research projects building and using scenarios have significant potential to benefit from involving a broad stakeholder group in developing qualitative narratives. The second phase involves complex quantitative simulations. In order to provide scientific rigor and credibility to the scenarios, this phase primarily calls for scholars with technical skills, knowledge on the research frontier and modelling experience. Nevertheless, later use of these scenarios in numerical policy studies can gain from resumed researcher-stakeholder interaction.

Employees’ perceptions and earnings benchmarks

PurposeEmployees, as internal stakeholders, not only play significant roles in a company’s operations but are also important users of a company’s financial information. However, prior accounting research to date has not explored whether employees incorporate a firm’s ability to meet earnings benchmarks in forming and revising their perceptions of firms. This study aims to focus on whether a firm’s ability to meet relevant earnings benchmarks impacts employees’ perceptions.Design/methodology/approachThe authors use employees’ perception scores from the 100 Best Companies to Work for from 1998 to 2015. The authors conduct an empirical study to examine the impact of beating earnings benchmarks on the perceptions of employees by estimating regression analyses. The dependent variable is employee perceptions of the firm. The variables of interest are the earnings growth and the analyst forecast benchmarks. The authors control for earnings performance and other determinants of employees’ perceptions.FindingsThe authors find that beating the earnings benchmarks is relevant for employees but has different impacts on the employees’ perceptions of firms. Specifically, both level and change analyses suggest that a firm’s ability to beat the earnings growth benchmark affects employees’ perceptions. However, the authors find no associations between employees’ perceptions and the analyst forecast benchmarks.Research limitations/implicationsThe authors recognize the amount of variation among the two groups’ perceptions from the binary variable creates an inherent limitation that the authors examine the best firms in terms of employee perceptions compared to the second-best firms. Therefore, the authors create another measure, EMPLOYEE_PERCEPTION2, which equals one if the firm’s ranking is within the top quartile and zero if the firm’s ranking is within the bottom quartile. This new variable increases the variation of employees’ perceptions in the sample to address the inherent limitation by allowing us to compare the best firms to the worst firms in the sample.Originality/valueThe study highlights the importance of beating earnings benchmarks for employees as a broader group of stakeholders. The study contributes to accounting benchmarks literature by exploring a different group of earnings benchmarks users. The authors also contribute to psychology studies by providing empirical evidence on the previously untested, intuitive prediction that employees’ views depend on a firm’s ability to meet relevant earnings benchmarks.

RoBDEMAT: A risk of bias tool and guideline to support reporting of pre-clinical dental materials research and assessment of systematic reviews

ObjectivesTo develop a risk of bias tool for pre-clinical dental materials research studies that aims to support reporting of future investigations and improve assessment in systematic reviews. MethodsA four-stage process following EQUATOR network recommendations was followed, which included project launch, literature review, Delphi process and the tool finalization. With the support of the European Federation of Conservative Dentistry (EFCD) and the Dental Materials Group of the International Association for Dental Research (DMG-IADR), a total of 26 expert stakeholders were included in the development and Delphi vote of the initial proposal. The proposal was built using data gathered from the literature review stage. During this stage, recent systematic reviews featuring dental materials research, and risk of bias tools found in the literature were comprehensively scanned for bias sources. The experts thus reached a consensus for the items, domains and judgement related to the tool, allowing a detailed guide for each item and corresponding signalling questions. ResultsThe tool features nine items in total, spread between 4 domains, pertaining to the following types of bias: bias related to planning and allocation (D1), specimen preparation (D2), outcome assessment (D3) and data treatment and outcome reporting (D4). RoBDEMAT, as presented, features signalling questions and a guide that can be used for RoB judgement. Its use as a checklist is preferred over a final summary score. ConclusionRoBDEMAT is the first risk of bias tool for pre-clinical dental materials research, supported and developed by a broad group of expert stakeholders in the field, validating its future use. Clinical significanceThis new tool will contribute the study field by improving the scientific quality and rigour of dental materials research studies and their systematic reviews. Such studies are the foundation and support of future clinical research and evidence-based decisions.

The NIDDK Diabetic Foot Consortium.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Diabetic Foot Consortium (DFC) was established in September 2018 by the NIDDK to build an organization to facilitate the highest quality of clinical research on diabetic foot ulcers (DFUs) that will answer clinically significant questions to improve DFU healing and prevent amputations. The initial focus of the DFC is to develop and validate biomarkers for DFUs that can be used in clinical care and research. The DFC consists of a data coordinating center (DCC) for operational oversight and statistical analysis, clinical sites for participant recruitment and evaluation, and biomarker analysis units (BAUs). The DFC is currently studying biomarkers to predict wound healing and recurrence and is collecting biosamples for future studies through a biorepository. The DFC plans to address the challenges of recruitment and eligibility criteria for DFU clinical trials by taking an approach of "No DFU Patient Goes Unstudied." In this platform approach, clinical history, DFU outcome, wound imaging, and biologic measurements from a large number of patients will be captured and the in-depth longitudinal data set will be analyzed to develop a computational-based DFU risk factor profile to facilitate scientifically sound clinical trial design. The DFC will expand its platform to include studies of the role of social determinants of health, such as food insecurity, housing instability, limited health literacy, and poor social support. The DFC is starting partnerships with the broad group of stakeholders in the wound care community.