Stakeholder engagement in European brain research: Experiences of the Lifebrain consortium

Abstract Introduction Stakeholder engagement remains scarce in basic brain research. However, it can greatly improve the relevance of investigations and accelerate the translation of study findings to policy. The Lifebrain consortium investigated risk and protective factors influencing brain health using cognition, lifestyle and imaging data from European cohorts. Stakeholder activities of Lifebrain—organized in a separate work package—included organizing stakeholder events, investigating public perceptions of brain health and dissemination. Here, we describe the experiences of researchers and stakeholders regarding stakeholder engagement in the Lifebrain project. Methods Stakeholder engagement in Lifebrain was evaluated through surveys among researchers and stakeholders and stakeholders' feedback at stakeholder events through evaluation forms. Survey data were analysed using a simple content analysis approach, and results from evaluation forms were summarized after reviewing the frequency of responses. Results Consortium researchers and stakeholders experienced the engagement activities as meaningful and relevant. Researchers highlighted that it made the research and research processes more visible and contributed to new networks, optimized data collection on brain health perceptions and the production of papers and provided insights into stakeholder views. Stakeholders found research activities conducted in the stakeholder engagement work package to be within their field of interest and research results relevant to their work. Researchers identified barriers to stakeholder engagement, including lack of time, difficulties in identifying relevant stakeholders, and challenges in communicating complex scientific issues in lay language and maintaining relationships with stakeholders over time. Stakeholders identified barriers such as lack of budget, limited resources in their organization, time constraints and insufficient communication between researchers and stakeholders. Conclusion Stakeholder engagement in basic brain research can greatly benefit researchers and stakeholders alike. Its success is conditional on dedicated human and financial resources, clear communication, transparent mutual expectations and clear roles and responsibilities. Public Contribution Patient organizations, research networks, policymakers and members of the general public were involved in engagement and research activities throughout the project duration.

translation of study findings to policy. The Lifebrain consortium investigated risk and protective factors influencing brain health using cognition, lifestyle and imaging data from European cohorts. Stakeholder activities of Lifebrain-organized in a separate work package-included organizing stakeholder events, investigating public perceptions of brain health and dissemination. Here, we describe the experiences of researchers and stakeholders regarding stakeholder engagement in the Lifebrain project.
Methods: Stakeholder engagement in Lifebrain was evaluated through surveys among researchers and stakeholders and stakeholders' feedback at stakeholder events through evaluation forms. Survey data were analysed using a simple content analysis approach, and results from evaluation forms were summarized after reviewing the frequency of responses. Research funders increasingly require health projects to engage stakeholders in all phases of research processes and governance to inform decision-making processes, 1-3 promote mutual learning and understanding between researchers and stakeholders 4,5 and facilitate the rapid translation of scientific findings into practical policy, including prevention as well as clinical practice. 6 Stakeholders are 'individuals, organizations or communities directly interested in the processes and outcomes of a project, research or policy endeavour'. 7 In health research, stakeholders usually include healthcare professionals, policymakers, industry representatives, patients and their caregivers and advocates, the research participants and the general public. 8 Stakeholder engagement refers to the process of involving stakeholders in research activities in which they are interested or by which they are affected to support shared understanding and effective decision-making. 7 Stakeholder engagement can take different forms but often includes activities allowing stakeholders to influence the conception, development and dissemination of research projects and facilitate the exchange of views and experiences. 8 Stakeholder engagement in clinical brain research is common and encouraged in contexts where, for instance, the views of patients are BUDIN-LJØSNE ET AL.
| 1319 needed to test the acceptance or efficacy of a treatment to inform clinical practice, [9][10][11] or to understand their experiences of disease progression. 10,12 In stark contrast, stakeholder engagement remains scarce in projects conducting basic science research on the structure and function of the brain. 13 This may partially be due to the nature of the research that, although providing important new and translatable knowledge, often produces findings of limited immediate clinical implications and may thus be perceived by researchers to be less relevant for stakeholders. 13 However, there are a few notable exceptions. The Human Brain Project 14 develops a research infrastructure for investigating brain biology and regularly interacts with stakeholders through the organization of stakeholder boards and citizen meetings to discuss the ethical, social and philosophical implications of neurological research. 15 The Australian Brain Initiative, an alliance of public and private actors in brain sciences, 16 engages researchers, healthcare professionals, policymakers, industry representatives and patient advocates in the development of national guidelines for ethically and socially robust neuroinnovation. 16 Principles and guidelines for Patient and Public Involvement have been developed, thereby providing researchers with concrete guidance on engaging different groups with research into neurodegenerative and brain diseases. 17,18 The guidelines suggest avenues for identifying relevant individuals and stakeholder organizations to engage in research, define their roles in the different phases of research projects and establish working agreements. However, knowledge about how to engage stakeholders in basic brain research in a way that is meaningful and does not put unreasonable demands on the parties involved remains limited. A stakeholder engagement process is highly context-dependent and demands resources in terms of logistical effort, time and funding. 19 It might also prove difficult to We hope that the recommendations will be relevant for future largescale health research projects, also outside the field of brain research.

| The Lifebrain consortium
Lifebrain was founded in January 2017 by the European Union's Horizon 2020 programme to conduct basic brain research exploring environmental, social, occupational and lifestyle factors affecting brain development, cognitive function and mental health at different stages of life. 21 The consortium investigated neuroscientific data, including brain imaging, demographic, cognitive, lifestyle, physical and mental health, blood markers and genetic data, from approximately 5200 participants across 14 project sites in Europe. 21 The consortium was organized into seven work packages responsible for different components of the project, including a work package dedicated to stakeholder engagement. This work package was allocated 5.8% of the consortium's total salary budget (580,000 EUR) and had approximately 35,000 EUR for organizing stakeholder activities during the 5.5 years of the project. Researchers in the consortium's partner institutions were invited to contribute to the work package voluntarily, and an interdisciplinary work package team led by a researcher with expertise in research ethics and stakeholder engagement was established across countries. Work package members brought expertise within environmental sciences, psychology, neuropsychology, neuroscience, psychiatry, neurology, blood biomarkers and communication.

| Stakeholder engagement in Lifebrain: Objectives and activities
Initially, the consortium aimed to exchange views with stakeholders and thereby benefit from their experiences and perspectives about how to promote brain health, increase public trust in brain research and enable the rapid uptake of research results in healthcare and public health policies. The consortium envisioned building a network of stakeholder organizations interested in brain health, cognition and mental health located in the countries of the project partners (Norway, Sweden, Germany, United Kingdom, Spain, Denmark, The Netherlands and Switzerland) or acting at European level, with whom a relationship was either already established or desirable.
After the project started, several steps were taken to organize the stakeholder engagement process, as summarized in Figure 1. Major stakeholder organizations identified were mandated to work with brain health, such as the national brain councils and brain foundations, or focused on neurogenerative and mental disorders, such as patient organizations and research centres. Finally, information about the stakeholder events, the Global Brain Health Survey, 23 and research results were disseminated with support from stakeholders.

| METHODS
To evaluate our stakeholder engagement in Lifebrain, we collected feedback from consortium researchers and stakeholders. In August 2021, we sent an anonymous online survey, hereafter referred to as the 'researcher survey', to 40 researchers in the consortium. The  useful. If what we ask of them is unspecific or something that we expect them to do in the future, then it can come to nothing.
One respondent noted that benefits are 'difficult to measure' and that 'a more intense stakeholder strategy would have allowed to better assess the impact'.
The researchers identified barriers and limitations to engaging stakeholders, including lack of time, difficulties in selecting relevant stakeholders as 'target stakeholder groups could be potentially many' and addressing the expectations and priorities of stakeholders and lack of common language: some researchers expressed concerns that the questions discussed required a certain scientific background. The translation of research outcomes into stakeholder advice in the form of 'specific messages that have a clear impact' and 'tangible and helpful feedback to clinicians' was also considered 'premature' by several researchers and a hindrance to stakeholder engagement.
Some researchers found it difficult to maintain relationships with stakeholders over time as 'stakeholders are not always institutions, but people representing these institutions, and people change'. One researcher believed that the COVID-19 pandemic had made science outreach more difficult. Engaging with people that are not usually easy to engage, i.e., the people that need it the most (outside of the standard highly motivated and educated people that always find their way into research, and already are able to find the information and help they need) or talking to people that have practice-based experience with these groups

| Results from the stakeholder survey
Seven out of nine stakeholder organizations completed the survey.
Most had agreed to collaborate with us on the Global Brain Health Survey 23 because they found it to be within their field of interest and believed that it had 'theoretical and practical implications for wellbeing and quality of life' and was 'an opportunity to involve volunteers in a multinational study'. The stakeholders thought they could use survey results in future information and lobbying campaigns related to brain health and to better understand the views of their target audience regarding brain health.
Most stakeholders experienced that the collaboration with the Lifebrain researchers was good, 'easy and successful', and appreciated being invited to follow-up workshops about survey results. They expressed interest in attending similar activities with Lifebrain, such as public meetings to disseminate results from the Global Brain Health Survey, 23

| Results from the evaluation forms shared at stakeholder events
In total, 104 evaluation forms were collected. Overall, the stakeholders found the stakeholder events interesting, informative, useful, and of appropriate duration. They believed participating in the events helped them gain a good overview of challenges and opportunities in the field of brain health and were willing to participate in future Lifebrain activities. As in other projects, we early on realized that stakeholder engagement required significant effort and that we had to limit our ambitions due to constraints on time and human resources. 1,2 Thus, we collaborated closely with only a restricted number of stakeholders, mostly umbrella patient organizations, as these had resources to engage with us and could make real contributions. 8 Engaging stakeholders in basic brain research is challenging as study findings often have limited direct practical implications. 13 In the stakeholder engagement work package, the research on public perceptions of brain health complemented our basic research efforts and provided additional knowledge of translational value and practical relevance to healthcare and public health policies. Inviting stakeholders to collaborate on investigating public perceptions of brain health, providing them with visibility as co-organizers of the research, and enabling them to use findings to inform their work, was a strong motivator for engagement. There are usually few incentives encouraging researchers to engage with stakeholders. 20 Developing the Global Brain Health Survey 23 enabled researchers in the consortium to engage with audiences and professionals they typically would not interact with directly while collecting research data. Future projects should consider conducting research that bridges basic science and the stakeholders' mandate to address societal health challenges.

| DISCUSSION
Recommendations have been made to establish clear ground rules for engagement activities and inform stakeholders about these rules. 1,30 This may include delineating stakeholder roles, responsibilities and expectations, establishing well-articulated plans for engagement activities and decision-making processes, 30 determining levels of engagement for each stakeholder group, outlining strategies for resolving conflicts and power imbalance issues and informing stakeholders about how their input will be integrated. 31,32 At the project start, we developed a stakeholder engagement plan, although it primarily outlined activities we aimed to conduct and did not articulate stringent rules for engagement. For each planned activity, we approached the relevant local stakeholders, discussed mutual expectations and made agreements for their contributions. This provided the stakeholders with sufficient flexibility to engage depending on their availability, interest, competence, resources and level of ambition and helped create an environment of trust and reciprocal respect. 6 Such flexibility was useful when the COVID-19 pandemic led to lockdowns and stringent restrictions on the organization of face-to-face meetings. Although we had to reduce on-site activities, we managed to pursue contact with stakeholders digitally and organized stakeholder events online, thus limiting the impact of the pandemic on our activities.
Overall, we did not encounter conflicts in our interactions with stakeholders. However, researchers raised concerns that results from the Global Brain Health Survey 23 may be rendered public when sharing aggregate results with stakeholders before publication in scientific journals, thus bypassing regular peer-review and quality assurance processes. Such concerns were not due to a lack of trust of the co-organizers but rather grounded in the thoughts that nonscientific stakeholders may not be familiar with rules and practices for scientific publication and may have an interest in acting immediately on new knowledge or by selecting specific outcomes. In the absence of detailed written agreements regarding their role and responsibilities in the research, the stakeholders found it to be at times unclear which survey data would be accessible for their use, and some stakeholders, not being scientists themselves, were uncomfortable in participating in the writing of scientific papers. In future projects, research activities are planned, it would be important already to clarify the respective responsibilities and contributions of stakeholders and researchers in the early stages of the project.
Finding good tools to evaluate the full impact of stakeholder engagement is difficult. Engagement activities are often interconnected, linked to several stages of the research process, and difficult to measure. 4 This may cause scepticism or indifference to the potential value of stakeholder engagement. In Lifebrain, we used surveys and evaluation forms to assess our stakeholder engagement.
This gave some insight into the perceived value of interactions between researchers and stakeholders, although it cannot be seen as a complete assessment of our stakeholder engagement. 33 Frameworks 34 and guidelines for stakeholder engagement exist, emphasizing the importance of predefined and validated evaluation tools, but such tools are not tailored to stakeholder engagement conducted in basic science. Future research is needed to develop specific tools to evaluate engagement activities. When planning future projects, researchers may use such tools early on, a priori, as an embedded component of the research process to support more intentional planning, development and reporting of stakeholder engagement activities.
It is particularly challenging for brain researchers in basic science to ensure academic excellence and societal impact simultaneously. Our experience from the Lifebrain project illustrates that stakeholder engagement is possible and can have a beneficial impact. The Norwegian Health Directorate recently published a report summarizing the experiences of 3 years with a national brain health strategy and outlined future steps. 35 The report relied on results from the Global Brain Health Survey 23 as a basis for outlining future work to increase brain health awareness. Achieving such an impact on health policy would not have been possible without the support and engagement of stakeholders. Engagement activities are more likely to be successful if they benefit both researchers and stakeholders.