Objective: To prepare a set of statements for randomised clinical trials (RCT) integrity through an international multi-stakeholder consensus. Methods: The consensus was developed via: multi-country multidisciplinary stakeholder group composition and engagement; evidence synthesis of 55 systematic reviews concerning RCT integrity; anonymised two-round modified Delphi survey with consensus threshold based on the average percentage of majority opinions; and, a final consensus development meeting. Prospective registrations: (https://osf.io/bhncy, https://osf.io/3ursn). Results: There were 30 stakeholders representing 15 countries from five continents including triallists, ethicists, methodologists, statisticians, consumer representatives, industry representatives, systematic reviewers, funding body panel members, regulatory experts, authors, journal editors, peer-reviewers and advisors for resolving integrity concerns. Delphi survey response rate was 86.7% (26/30 stakeholders). There were 111 statements (73 stakeholder-provided, 46 systematic review-generated, 8 supported by both) in the initial long list, with eight additional statements provided during the consensus rounds. Through consensus the final set consolidated 81 statements (49 stakeholder-provided, 41 systematic review-generated, 9 supported by both). The entire RCT life cycle was covered by the set of statements including general aspects (n = 6), design and approval (n = 11), conduct and monitoring (n = 19), reporting of protocols and findings (n = 20), post-publication concerns (n = 12), and future research and development (n = 13). Conclusion: Implementation of this multi-stakeholder consensus statement is expected to enhance RCT integrity.
MULTIFILE
Background: Patient involvement in interprofessional education (IPE) is a new approach in fostering person-centeredness and collaborative competencies in undergraduate students. We developed the Patient As a Person (PAP-)module to facilitate students in learning from experts by experience (EBEs) living with chronic conditions, in an interprofessional setting. This study aimed to explore the experiences of undergraduate students, EBEs and facilitators with the PAP-module and formulate recommendations on the design and organization of patient involvement in IPE. Methods: We collected data from students, EBEs and facilitators, through eight semi-structured focus group interviews and two individual interviews (N = 51). The interviews took place at Maastricht University, Zuyd University of Applied Sciences and Regional Training Center Leeuwenborgh. Conventional content analysis revealed key themes. Results: Students reported that learning from EBEs in an interprofessional setting yielded a more comprehensive approach and made them empathize with EBEs. Facilitators found it challenging to address multiple demands from students from different backgrounds and diverse EBEs. EBEs were motivated to improve the personcentredness of health care and welcomed a renewed sense of purpose. Conclusions: This study yielded six recommendations: (a) students from various disciplines visit an EBE to foster a comprehensive approach, (b) groups of at least two students visit EBEs, (c) students may need aftercare for which facilitators should be receptive, (d) EBEs need clear instruction on their roles, (e) multiple EBEs in one session create diversity in perspectives and (f) training programmes and peer-to-peer sessions for facilitators help them to interact with diverse students and EBEs.
The goal of a local energy community (LEC) is to create a more sustainable, resilient, and efficient energy system by reducing dependence on centralized power sources and enabling greater participation and control by local communities and individuals. LEC requires transformations in local energy systems, and strongly depends on the preferences and actions of the local actors involved. The necessity for extensive stakeholder involvement adds complexity to the energy transition, posing a significant challenge for all involved parties. The municipality of Leidschendam-Voorburg has committed to the national decision for energy transition. It has taken a strategic approach by proceeding De Heuvel/Amstelwijk as the pioneer in this initiative, leading the way for other neighborhoods to follow. It is crucial to devise strategies that effectively facilitate stakeholder engagement. To this end, a thorough stakeholder analysis is needed. Such an analysis can focus on the identification of key stakeholders, their interests, their influence, and their behavioral characteristics in relation to the energy transition. Additionally, it's crucial to uncover the challenges encountered by these stakeholders and finally develop appropriate strategies to address them hence enhance their engagement. This thesis begins with an introduction to the research background, including a presentation of the case study and a statement of the problem identified in the field, followed by the research questions underpinning the study. A thorough literature review ensues, providing a robust synthesis of existing research relating to stakeholder engagement in LECs, with a view to expediting energy transitions. The literature review not only forms the foundation for the research methods adopted in this study but also promotes in the construction of the conceptual model. Subsequent to the literature review, the research method is detailed. The filed research is conducted in five steps: Step 1 - identification of stakeholders, Step 2 - prioritization of stakeholders, Step 3 - interviewing, Step 4 - data analysis, including stakeholder profiling with mapping and addressing challenges, and finally, Step 5 - proposal of strategies for stakeholder engagement enhancement based on the expected and current levels of stakeholders engagement. This research collects necessary information to understand the profiles of stakeholders in De Heuvel/Amstelwijk, tackle challenges faced by different stakeholders, propose strategies to increase stakeholders engagement. It not only aims to enrich the depth of theoretical knowledge on the subject matter but also strives to aid in the development of a localized energy strategy that is optimally suited for the De Heuvel/Amstelwijk neighborhood as good example for other neighborhoods.
Coastal nourishments, where sand from offshore is placed near or at the beach, are nowadays a key coastal protection method for narrow beaches and hinterlands worldwide. Recent sea level rise projections and the increasing involvement of multiple stakeholders in adaptation strategies have resulted in a desire for nourishment solutions that fit a larger geographical scale (O 10 km) and a longer time horizon (O decades). Dutch frontrunner pilot experiments such as the Sandmotor and Ameland inlet nourishment, as well as the Hondsbossche Dunes coastal reinforcement project have all been implemented from this perspective, with the specific aim to encompass solutions that fit in a renewed climate-resilient coastal protection strategy. By capitalizing on recent large-scale nourishments, the proposed Coastal landSCAPE project C-SCAPE will employ and advance the newly developed Dynamic Adaptive Policy Pathways (DAPP) approach to construct a sustainable long-term nourishment strategy in the face of an uncertain future, linking climate and landscape scales to benefits for nature and society. Novel long-term sandy solutions will be examined using this pathways method, identifying tipping points that may exist if distinct strategies are being continued. Crucial elements for the construction of adaptive pathways are 1) a clear view on the long-term feasibility of different nourishment alternatives, and 2) solid, science-based quantification methods for integral evaluation of the social, economic, morphological and ecological outcomes of various pathways. As currently both elements are lacking, we propose to erect a Living Lab for Climate Adaptation within the C-SCAPE project. In this Living Lab, specific attention is paid to the socio-economic implications of the nourished landscape, as we examine how morphological and ecological development of the large-scale nourishment strategies and their design choices (e.g. concentrated vs alongshore uniform, subaqueous vs subaerial, geomorphological features like artificial lagoons) translate to social acceptance.
In Amsterdam's neighbourhoods, much of the waste that is disposed has the potential of becoming something else by means of recycling or upcycling. Zero Waste lab –which is part of the organization De Gezonde Stad- is a place where inhabitants can bring their own separated waste in exchange for value coins. Now, Zero Waste Lab now wants to take this a step forward and further develop their own project: from recycling to upcycling waste. In this endeavour, HvA will collaborate by researching the possibilities for upcycling a local waste stream by means of digital production pro-cesses, as well as ways of involving the neighbourhood. Because it is of vital importance for the project not only to be technically possible, but also scalable and economically feasible, Zero Waste Lab and HvA have asked for partnership to the company Verdraaid Goed. This partnership and specific case study, presented here as ‘Wood for the neighborhood’ can be summa-rized in four main goals: • (Production) Explore the design and manufacturing possibilities of using digital production to upcycle a local wood waste stream (with an industrial robotic arm) • (Design) Show how explorative research, when carried on from the beginning of the de-sign process, can bring great added value to the development of project concepts. • (Social) Demonstrate that involving stakeholders early in the process of reusing and de-signing with waste materials can shape the future in new directions • (All three) Highlight how this case study is relevant and fits the principles of the circular economy.
Single-Use Plastics (SUPs) are at the centre of European Union Agenda aiming at reducing the plastic soup with the EU Directive 2019/904. SUPs reduction is pivotal also in the Dutch Government Agenda for the transition to a Circular Economy by 2050. Worldwide the data on SUPs use and disposal are impressive: humans use around 1.2 million plastic bottles per minute; approximately 91% of plastic is not recycled (www.earthday.org/fact-sheet-single-use-plastics/). While centralised processes of waste collection, disposal, and recycling strive to cope with such intense use of SUPs, the opportunities and constraints of establishing a networked grid of facilities enacting processes of SUPs collection and recycling with the active involvement of local community has remained unexplored. The hospitality sector is characterised by a widespread capillary network of small hospitality firms nested in neighbourhoods and rural communities. Our research group works with small hospitality firms, different stakeholders, and other research groups to prompt the transition of the hospitality sector towards a Circular Economy embracing not only the environmental and economic dimensions but also the social dimension. Hence, this project explores the knowledge and network needed to build an innovative pilot allowing to close the plastic loop within a hospitality facility by combining a 3D printing process with social inclusiveness. This will mean generating key technical and legal knowledge as well as a network of strategic experts and stakeholders to be involved in an innovative pilot setting a 3D printing process in a hospitality facility and establishing an active involvement of the local community. Such active involvement of the local inhabitants will be explored as SUPs collectors and end-users of upcycled plastics items realised with the 3D printer, as well as through opportunities of vocational training and job opportunities for citizens distant from the job market.
