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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
Our world is increasingly faced with wicked environmental sustainability challenges, requiring entrepreneurs to work in multi-stakeholder initiatives (MSIs) to address these challenges. Network orchestration is essential for these MSIs to realize their sustainability goals and make an impact. The concept of opportunity beliefs is central in understanding the actions taken by these entrepreneurs. However, the current theorization of opportunity beliefs formation is individual-centric. Furthermore, there is little understanding of how orchestration influences the opportunity beliefs formation in multi-stakeholder teams. We build on the framework of McMullen and Shepherd (2016), who presented a two-stage model of how third-person opportunity beliefs transform into first-person opportunity beliefs. We advance two contributions by using a single case study and applying the Gioia method to code and analyze the data. First is a two-stage model consisting of the formation of joint first-person opportunity beliefs that suggests that value-aligning and informing resource orchestration activities are essential in this process. Second, we advance the idea that the resource orchestration activities have both enabling and adversely constraining effects impairing the formation of joint first-person opportunity beliefs under conditions of organizational pressure.
We examine the demise of a multi-stakeholder network that was launched to promote an inclusive dairy market in Ethiopia to better understand why nongovernmental organizations (NGOs) may develop interventions in contexts of poverty that fail to endure after they exit. We identify organizational reflexivity – the capacity to recognize and understand the recursive interplay between an intervention and the local environment – as a key explanatory mechanism for this intervention outcome. Limited reflexivity not only prevented the NGO we studied from properly aligning the intervention with the context (design failures), but also prevented the organization from adjusting its intervention when negative feedback emerged (orchestration failures), which eventually evolved into the demise of the network (maintenance failure). While our study confirms the theoretical premise that NGOs need to contextualize their interventions, we expand current knowledge by highlighting the role of organizational reflexivity in this process. Moreover, by showing how reflexivity deficits can trigger a cascade of failure, especially when intervening in voids where incumbent firms have interests in maintaining the void, our study calls attention to the politicized nature of institutional voids.
This Impuls 2020 proposal of ArtEZ University of the Arts focuses on strengthening the institutional structure and organizational infrastructure of its Research and Outreach Unit, by developing and building ArtEZ Research & Outreach. ArtEZ Research & Outreach is a centralized research incubation and development space to facilitate the large communities of researchers at ArtEZ. Based on the portfolio of diverse practices, disciplinary competences, and domain expertise, it explores and develops common grounds for new ways of shared, de-disciplined research and outreach activities across the university and with relevant external partners and stakeholders. The 2 key areas in which Impuls-activities will be performed are: 1. Strategic Research Programming and Networking – Aligning expertise, combining research resources and developing strategic networks Our first objective is to define a long-term Strategic Research Program, to set the directions of urgent and future-proof research topics, directly related to needs and demands from internal (research, education) and external (societal, industrial) stakeholders, with the ambition to create maximum value and impact for researchers, students and professionals and preserving the power of art. This area also includes networking, to develop diverse multi-stakeholder consortia within and around the selected strategic research topics. Our objective is to create multi-lateral exchanges, bringing people together in diverse communities for building consortia to prepare for joint practices of research, impact, accountability, and intervention towards collective research development. 2. Professional Research Support Infrastructure We need to develop and professionalize our research support infrastructure to facilitate professors and researchers in preparing, performing and managing (organizationally and financially) their research projects. The ambition is to increase ArtEZ’ participation in projects for research in the arts, from networking to dissemination and implementation of the research results and output, by developing a strong and sustainable research portfolio and financing strategy.