Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy.

BACKGROUND: The European Regulation on Health Technology Assessment (EU HTA R), effective since January 2022, aims to harmonize and improve the efficiency of common HTA across Member States (MS), with a phased implementation from January 2025. At "midterms" of the preparation phase for the implementation of the Regulation our aim was to identify and prioritize tangible action points to move forward. METHODS: During the 2023 Spring Convention of the European Access Academy (EAA), participants from different nationalities and stakeholder backgrounds discussed readiness and remaining challenges for the Regulation's implementation and identified and prioritized action points. For this purpose, participants were assigned to four working groups: (i) Health Policy Challenges, (ii) Stakeholder Readiness, (iii) Approach to Uncertainty and (iv) Challenges regarding Methodology. Top four action points for each working group were identified and subsequently ranked by all participants during the final plenary session. RESULTS: Overall "readiness" for the Regulation was perceived as neutral. Prioritized action points included the following: Health Policy, i.e. assess adjustability of MS laws and health policy processes; Stakeholders, i.e. capacity building; Uncertainty, i.e. implement HTA guidelines as living documents; Methodology, i.e. clarify the Population, Intervention, Comparator(s), Outcomes (PICO) identification process. CONCLUSIONS: At "midterms" of the preparation phase, the focus for the months to come is on executing the tangible action points identified at EAA's Spring Convention. All action points centre around three overarching themes: harmonization and standardization, capacity building and collaboration, uncertainty management and robust data. These themes will ultimately determine the success of the EU HTA R in the long run.

Evidence-based practice in traditional persian medicine (TPM): a stakeholder and social network analysis.

BACKGROUND: The utilization of complementary and alternative medicine (CAM) is experiencing a global surge, accompanied by the adoption of national CAM policies in numerous countries. Traditional Persian medicine (TPM) is highly used as CAM in Iran, and the ongoing scientific evaluation of its interventions and the implementation of evidence-based medicine (EBM) encounters various barriers. Therefore, comprehending the characteristics and interactions of stakeholders is pivotal in advancing EBM within TPM policies. In this study, we utilized both classical stakeholder analysis and social network analysis to identify key stakeholders and potential communication patterns, thereby promoting EBM in TPM policy-making. METHODS: A cross-sectional nationwide stakeholder analysis was conducted in 2023 using snowball sampling. The interviews were carried out using a customized version of the six building blocks of health. Data were collected through semi-structured interviews. Stakeholders were assessed based on five factors (power, interest, influence, position, and competency). The connections and structure of the network were analyzed using degree, betweenness, closeness centrality, and modularity index to detect clusters of smaller networks. RESULTS: Among twenty-three identified stakeholders, the Ministry of Health and Medical Education (MOHME) and the Public were the most powerful and influential. The Iranian Academy of Medical Sciences was the most competent stakeholder. Social network analysis revealed a low density of connections among stakeholders. Pharmaceutical companies were identified as key connectors in the network, while the Public, supreme governmental bodies, and guilds acted as gatekeepers or brokers. The MOHME and Maraji were found to be high-ranking stakeholders based on four different centrality measures. CONCLUSION: This study identifies powerful stakeholders in the network and emphasizes the need to engage uninterested yet significant stakeholders. Recommendations include improving competence through education, strengthening international relations, and fostering stronger relationships. Engaging key connectors and gatekeepers is essential for bridging gaps in the network.

The Development of Principles for Patient and Public Involvement (PPI) in Preclinical Spinal Cord Research: A Modified Delphi Study.

INTRODUCTION: There is currently limited guidance for researchers on Patient and Public Involvement (PPI) for preclinical spinal cord research, leading to uncertainty about design and implementation. This study aimed to develop evidence-informed principles to support preclinical spinal cord researchers to incorporate PPI into their research. METHODS: This study used a modified Delphi method with the aim of establishing consensus on a set of principles for PPI in spinal cord research. Thirty-eight stakeholders including researchers, clinicians and people living with spinal cord injury took part in the expert panel. Participants were asked to rate their agreement with a series of statements relating to PPI in preclinical spinal cord research over two rounds. As part of Round 2, they were also asked to rate statements as essential or desirable. RESULTS: Thirty-eight statements were included in Round 1, after which five statements were amended and two additional statements were added. After Round 2, consensus (> 75% agreement) was reached for a total of 27 principles, with 13 rated as essential and 14 rated as desirable. The principles with highest agreement related to diversity in representation among PPI contributors, clarity of the purpose of PPI and effective communication. CONCLUSION: This research developed a previously unavailable set of evidence-informed principles to inform PPI in preclinical spinal cord research. These principles provide guidance for researchers seeking to conduct PPI in preclinical spinal cord research and may also inform PPI in other preclinical disciplines. PATIENT AND PUBLIC INVOLVEMENT STATEMENT: This study was conducted as part of a project aiming to develop PPI in preclinical spinal cord injury research associated with an ongoing research collaboration funded by the Irish Rugby Football Union Charitable Trust (IRFU CT) and the Science Foundation Ireland Centre for Advanced Materials and BioEngineering Research (SFI AMBER), with research conducted by the Tissue Engineering Research Group (TERG) at the RCSI University of Medicine and Health Sciences. The project aims to develop an advanced biomaterials platform for spinal cord repair and includes a PPI Advisory Panel comprising researchers, clinicians and seriously injured rugby players to oversee the work of the project. PPI is included in this study through the involvement of members of the PPI Advisory Panel in the conceptualisation of this research, review of findings, identification of key points for discussion and preparation of the study manuscript as co-authors.

The development of a set of key points to aid clinicians and researchers in designing and conducting n-of-1 trials.

INTRODUCTION: n-of-1 trials are undertaken to optimise the evaluation of health technologies in individual patients. They involve a single patient receiving treatments, both interventional and control, consecutively over set periods of time, the order of which is decided at random. Although n-of-1 trials are undertaken in medical research it could be argued they have the utility to be undertaken more frequently. We undertook the National Institute for Health Research (NIHR) commissioned DIAMOND (Development of generalisable methodology for n-of-1 trials delivery for very low volume treatments) project to develop key points to assist clinicians and researchers in designing and conducting n-of-1 trials. METHODS: The key points were developed by undertaking a stakeholder workshop, followed by a discussion within the study team and then a stakeholder dissemination and feedback event. The stakeholder workshop sought to gain the perspectives of a variety of stakeholders (including clinicians, researchers and patient representatives) on the design and use of n-of-1 trials. A discussion between the study team was held to reflect on the workshop and draft the key points. Lastly, the stakeholders from the workshop were invited to a dissemination and feedback session where the proposed key points were presented and their feedback gained. RESULTS: A set of 22 key points were developed based on the insights from the workshop and subsequent discussions. They provide guidance on when an n-of-1 trial might be a viable or appropriate study design and discuss key decisions involved in the design of n-of-1 trials, including determining an appropriate number of treatment periods and cycles, the choice of comparator, recommended approaches to randomisation and blinding, the use of washout periods and approaches to analysis. CONCLUSIONS: The key points developed in the project will support clinical researchers to understand key considerations when designing n-of-1 trials. It is hoped they will support the wider implementation of the study design.

Stakeholder perspectives of immunisation delivery for adolescents with disability in specialist schools in Victoria, Australia: 'we need a vaccination pathway'.

BACKGROUND: Adolescents with disability have lower vaccination rates than the general population, including HPV vaccination. Understanding the multi-level influences on vaccination in specialist schools is crucial to achieve optimal vaccination coverage and vaccination experiences for adolescents living with disability. OBJECTIVE: To identify and improve understanding of the facilitators and barriers of HPV vaccination among adolescents with intellectual disabilities or autism in Victorian specialist schools to inform strategies to increase vaccination acceptance and uptake. METHODS: Qualitative interviews with key stakeholders (adolescents with disabilities, parents, school and council immunisation staff) from six specialist schools in Victoria, Australia. Data were analysed thematically. Inductively derived themes were then deductively mapped across the UNICEF 'Journey to Immunization' model. RESULTS: 32 interviews were conducted with stakeholders (2 adolescents, 7 parents, 13 school staff, 10 council staff). Trust in vaccines was high, but knowledge of the HPV vaccine was limited. Barriers included lack of accessible information for parents, the consent process, behavioural challenges and vaccine-related anxiety among students. The immunisation program in special schools was perceived as convenient, however preparing students for vaccination day and catering to individual student needs were key. Participants expressed a need for more parent information about options and additional support for vaccination outside of the school program. CONCLUSIONS: Our study identified a range of facilitators and barriers to the school immunisation program for students with disabilities in specialist schools. The next phase of this work will use co-design workshops to build on the suggestions for improvement and opportunities that could be leveraged to improve vaccination uptake.

'It's not making a decision, it's prompting the discussions': a qualitative study exploring stakeholders' views on the acceptability and feasibility of advance research planning (CONSULT-ADVANCE).

BACKGROUND: Health and care research involving people who lack capacity to consent requires an alternative decision maker to decide whether they participate or not based on their 'presumed will'. However, this is often unknown. Advance research planning (ARP) is a process for people who anticipate periods of impaired capacity to prospectively express their preferences about research participation and identify who they wish to be involved in future decisions. This may help to extend individuals' autonomy by ensuring that proxy decisions are based on their actual wishes. This qualitative study aimed to explore stakeholders' views about the acceptability and feasibility of ARP and identify barriers and facilitators to its implementation in the UK. METHODS: We conducted semi-structured interviews with 27 researchers, practitioners, and members of the public who had participated in a preceding survey. Interviews were conducted remotely between April and November 2023. Data were analysed thematically. RESULTS: Participants were supportive of the concept of ARP, with differing amounts of support for the range of possible ARP activities depending on the context. Six main themes were identified: (1) Planting a seed - creating opportunities to initiate/engage with ARP; (2) A missing part of the puzzle - how preferences expressed through ARP could help inform decisions; (3) Finding the sweet spot - optimising the timing of ARP; (4) More than a piece of paper - finding the best mode for recording preferences; (5) Keeping the door open to future opportunities - minimising the risk of unintended consequences; and (6) Navigating with a compass - principles underpinning ARP to ensure safeguarding and help address inequalities. Participants also identified a number of implementation challenges, and proposed facilitative strategies that might overcome them which included embedding advance research planning in existing future planning processes and research-focused activities. CONCLUSIONS: This study provides a routemap to implementing ARP in the UK to enable people anticipating impaired capacity to express their preferences about research, thus ensuring greater opportunities for inclusion of this under-served group, and addressing the decisional burden experienced by some family members acting as proxies. Development of interventions and guidance to support ARP is needed, with a focus on ensuring accessibility.

Impact of stakeholder pressure on digital process innovation: An empirical analysis.

Digital technologies can bring about fundamental changes in corporate processes, which may result in a shift from process innovation to digital process innovation. However, owing to resource constraints and various stakeholders, digital process implementation is extremely challenging for firms. Based on stakeholder theory, this study explores whether and how stakeholder pressure for digitalization can facilitate corporate digital process innovation and unravels the mediating effect of routine reconfiguration and the moderating effect of strategic flexibility. The findings from a survey of 351 firms prove that stakeholder pressure for digitalization can facilitate corporate digital process innovation via routine reconfiguration. Moreover, this study finds that increased strategic flexibility can strengthen the positive mediating effect of routine reconfiguration. The findings contribute to the deep understanding of digital process innovation and offer a boundary condition for the effectiveness of stakeholder pressure.

Stakeholders' views of the Baby Friendly Initiative implementation and impact: a mixed methods study.

BACKGROUND: The Baby Friendly Hospital Initiative (BFHI) was launched in 1991 as an intervention to support healthy infant feeding practices, but its global coverage remains around 10%. This study aimed to explore stakeholders' views of the Baby Friendly Initiative (BFI) programme, the barriers and facilitators to accreditation and its perceived impact. METHODS: A mixed methods approach was used. An online survey was distributed through numerous professional networks from September 2020 to November 2020. Quantitative data were analyzed using descriptive statistics, with simple content analysis undertaken on open-ended responses. Individual semi-structured interviews were also undertaken and analyzed using inductive thematic analysis. RESULTS: A total of 322 respondents completed the survey in part or in full, mainly from the United Kingdom. Fifteen key stakeholders and two maternity service users undertook interviews. Respondents were from various professional backgrounds and currently worked in different roles including direct care of women and their families, public health, education and those responsible for purchasing health services. Survey respondents viewed the BFI to have the greatest impact on breastfeeding initiation, duration, and infant health outcomes. Three overall themes were identified. The first was "BFI as an agent for change". Most participants perceived the need to implement the whole package, but views were mixed regarding its impact and the accreditation process. Secondly, BFI was regarded as only "one part of a jigsaw", with no single intervention viewed as adequate to address the complex cultural context and social and health inequities that impact breastfeeding. Finally, "cultural change and education" around breastfeeding were viewed as essential for women, staff and society. CONCLUSIONS: The BFI is not a magic bullet intervention. To create a more supportive breastfeeding environment within society a holistic approach is required. This includes social and cultural changes, increased education ideally starting at school age, and advancing positive messaging around breastfeeding within the media, as well as fully banning breastmilk substitute advertising. Although the BFI comprises a whole package, few survey respondents rated all aspects as equally important. Additional evidence for the effectiveness of each element and the importance of the whole package need to be established and communicated.

How to strengthen societal impact of research and innovation? Lessons learned from an explanatory research-on-research study on participatory knowledge infrastructures funded by the Netherlands Organization for Health Research and Development.

BACKGROUND: Scientific research and innovation can generate societal impact via different pathways. Productive interactions, such as collaboration between researchers and relevant stakeholders, play an important role and have increasingly gained interest of health funders around the globe. What works, how and why in research partnerships to generate societal impact in terms of knowledge utilisation is still not well-known. To explore these issues, the Netherlands Organization for Health Research and Development (ZonMw) initiated an exploratory research-on-research study with a focus on participatory knowledge infrastructures (PKIs) that they fund in the field of public health and healthcare. PKIs are sustainable infrastructures in which knowledge production, dissemination and utilisation takes place via committed collaboration between researchers and stakeholders from policy, practice and/or education. Examples are learning networks, academic collaborative centres, care networks and living labs. The aim of the study was twofold: to gain insights in what constitutes effective collaboration in PKIs; and to learn and improve the research governance, particularly of ZonMw as part of their dissemination and implementation activities. METHODS: During 2020-2022, we conducted a literature review on long-term research partnerships, analysed available documentation of twenty ZonMw-funded PKIs, surveyed participants of the 2021 European Implementation Event, interviewed steering committee members, organized a Group Decision Room with lecturers, and validated the findings with key experts. RESULTS: We identified eight mechanisms ('how and why') that are conditional for effective collaboration in PKIs: transdisciplinary collaboration; defining a shared ambition; doing justice to everyone's interests; investing in personal relationships; a professional organisation or structure; a meaningful collaborative process; mutual trust, sufficient time for and continuity of collaboration. Several factors ('what') may hinder (e.g., lack of ownership or structural funding) or facilitate (e.g., stakeholder commitment, embeddedness in an organisation or policy) effective collaboration in research partnerships. CONCLUSION: To use the study results in policy, practice, education, and/or (further) research, cultural and behavioural change of all stakeholders is needed. To facilitate this, we provide recommendations for funding organisations, particularly ZonMw and its partners within the relevant knowledge ecosystem. It is meant as a roadmap towards the realisation and demonstration of societal impact of (health) research and innovation in the upcoming years.

Assessing AI Awareness and Identifying Essential Competencies: Insights From Key Stakeholders in Integrating AI Into Medical Education.

Background: The increasing importance of artificial intelligence (AI) in health care has generated a growing need for health care professionals to possess a comprehensive understanding of AI technologies, requiring an adaptation in medical education. Objective: This paper explores stakeholder perceptions and expectations regarding AI in medicine and examines their potential impact on the medical curriculum. This study project aims to assess the AI experiences and awareness of different stakeholders and identify essential AI-related topics in medical education to define necessary competencies for students. Methods: The empirical data were collected as part of the TüKITZMed project between August 2022 and March 2023, using a semistructured qualitative interview. These interviews were administered to a diverse group of stakeholders to explore their experiences and perspectives of AI in medicine. A qualitative content analysis of the collected data was conducted using MAXQDA software. Results: Semistructured interviews were conducted with 38 participants (6 lecturers, 9 clinicians, 10 students, 6 AI experts, and 7 institutional stakeholders). The qualitative content analysis revealed 6 primary categories with a total of 24 subcategories to answer the research questions. The evaluation of the stakeholders' statements revealed several commonalities and differences regarding their understanding of AI. Crucial identified AI themes based on the main categories were as follows: possible curriculum contents, skills, and competencies; programming skills; curriculum scope; and curriculum structure. Conclusions: The analysis emphasizes integrating AI into medical curricula to ensure students' proficiency in clinical applications. Standardized AI comprehension is crucial for defining and teaching relevant content. Considering diverse perspectives in implementation is essential to comprehensively define AI in the medical context, addressing gaps and facilitating effective solutions for future AI use in medical studies. The results provide insights into potential curriculum content and structure, including aspects of AI in medicine.

Ten Priorities for Research Addressing the Intersections of Brain Injury, Mental Health and Addictions: A Stakeholder-Driven Priority-Setting Study.

OBJECTIVES: The purpose of this study was to engage key stakeholders in a health research priority-setting process to identify, prioritize and produce a community-driven list of research questions addressing intersectional issues on mental health and addictions (MHA) in acquired brain injury (ABI). METHODS: A multiphasic health research priority-setting process was co-designed and executed with community-based stakeholders, including researchers, health professionals, clinicians, service providers, representatives from brain injury associations, policy makers and people with lived experience of ABI and MHA, including patients and their family members. Stakeholders' ideas led to the generation of research questions, which were prioritized at a 1-day workshop. RESULTS: Fifty-nine stakeholders participated in the priority-setting activity during the workshop, which resulted in a rank-ordered list of the top 10 questions for research addressing the intersections of ABI and MHA. Questions identified touched on several pressing issues (e.g., opioid crisis, homelessness), encompassed multiple subtypes of ABI (e.g., hypoxic-ischaemic, mild traumatic), and involved different domains (e.g., identification, intervention) of health research. CONCLUSIONS: This community-driven health research priority-setting study identified and prioritized research questions addressing the intersections of ABI and MHA. Researchers and funding agencies should use this list to inform their agendas and address stakeholders' most urgent needs, fostering meaningful improvements to clinical services. PATIENT OR PUBLIC CONTRIBUTION: An 11-person working group comprised of people with lived experience, service providers, researchers, healthcare professionals and other key stakeholders collaboratively developed and informed the scope, design, methodology and interpretation of this study. Over 50 community-based stakeholders contributed to the research priority-setting activity. One co-author is a person with lived experience.

Integrating virtual patients into undergraduate health professions curricula: a framework synthesis of stakeholders' opinions based on a systematic literature review.

BACKGROUND: Virtual patients (VPs) are widely used in health professions education. When they are well integrated into curricula, they are considered to be more effective than loosely coupled add-ons. However, it is unclear what constitutes their successful integration. The aim of this study was to identify and synthesise the themes found in the literature that stakeholders perceive as important for successful implementation of VPs in curricula. METHODS: We searched five databases from 2000 to September 25, 2023. We included qualitative, quantitative, mixed-methods and descriptive case studies that defined, identified, explored, or evaluated a set of factors that, in the perception of students, teachers, course directors and researchers, were crucial for VP implementation. We excluded effectiveness studies that did not consider implementation characteristics, and studies that focused on VP design factors. We included English-language full-text reports and excluded conference abstracts, short opinion papers and editorials. Synthesis of results was performed using the framework synthesis method with Kern's six-step model as the initial framework. We appraised the quality of the studies using the QuADS tool. RESULTS: Our search yielded a total of 4808 items, from which 21 studies met the inclusion criteria. We identified 14 themes that formed an integration framework. The themes were: goal in the curriculum; phase of the curriculum when to implement VPs; effective use of resources; VP alignment with curricular learning objectives; prioritisation of use; relation to other learning modalities; learning activities around VPs; time allocation; group setting; presence mode; VPs orientation for students and faculty; technical infrastructure; quality assurance, maintenance, and sustainability; assessment of VP learning outcomes and learning analytics. We investigated the occurrence of themes across studies to demonstrate the relevance of the framework. The quality of the studies did not influence the coverage of the themes. CONCLUSIONS: The resulting framework can be used to structure plans and discussions around implementation of VPs in curricula. It has already been used to organise the curriculum implementation guidelines of a European project. We expect it will direct further research to deepen our knowledge on individual integration themes.

Applying the WHO-INTEGRATE evidence-to-decision framework in the development of WHO guidelines on parenting interventions: step-by-step process and lessons learnt.

BACKGROUND: Development of guidelines for public health, health system, and health policy interventions demands complex systems thinking to understand direct and indirect effects of interventions within dynamic systems. The WHO-INTEGRATE framework, an evidence-to-decision framework rooted in the norms and values of the World Health Organization (WHO), provides a structured method to assess complexities in guidelines systematically, such as the balance of an intervention's health benefits and harms and their human rights and socio-cultural acceptability. This paper provides a worked example of the application of the WHO-INTEGRATE framework in developing the WHO guidelines on parenting interventions to prevent child maltreatment, and shares reflective insights regarding the value added, challenges encountered, and lessons learnt. METHODS: The methodological approach comprised describing the intended step-by-step application of the WHO-INTEGRATE framework and gaining reflective insights from introspective sessions within the core team guiding the development of the WHO guidelines on parenting interventions and a methodological workshop. RESULTS: The WHO-INTEGRATE framework was used throughout the guideline development process. It facilitated reflective deliberation across a broad range of decision criteria and system-level aspects in the following steps: (1) scoping the guideline and defining stakeholder engagement, (2) prioritising WHO-INTEGRATE sub-criteria and guideline outcomes, (3) using research evidence to inform WHO-INTEGRATE criteria, and (4) developing and presenting recommendations informed by WHO-INTEGRATE criteria. Despite the value added, challenges, such as substantial time investment required, broad scope of prioritised sub-criteria, integration across diverse criteria, and sources of evidence and translation of insights into concise formats, were encountered. CONCLUSIONS: Application of the WHO-INTEGRATE framework was crucial in the integration of effectiveness evidence with insights into implementation and broader implications of parenting interventions, extending beyond health benefits and harms considerations and fostering a whole-of-society-perspective. The evidence reviews for prioritised WHO-INTEGRATE sub-criteria were instrumental in guiding guideline development group discussions, informing recommendations and clarifying uncertainties. This experience offers important lessons for future guideline panels and guideline methodologists using the WHO-INTEGRATE framework.

Moving from idea to reality: The barriers and enablers to implementing Child and Family Hubs policy into practice in NSW, Australia.

BACKGROUND: Adverse childhood experiences can impact physical and mental health throughout the lifespan. To support families experiencing adversity and improve child health and developmental equity, an integrated, multi-sector response is required. Child and Family Hubs (Hubs) are a feasible and acceptable approach to providing such a response. In the Australian context, a number of federal and New South Wales (NSW) state policies support an integrated, multi-sector response using Hubs to support families experiencing adversity. This study examined NSW policy stakeholder and health service manager perspectives on the barriers and enablers to translating policy into practice in the implementation of Child and Family Hubs. METHODS: Semi-structured interviews were conducted with 11 NSW government policy stakeholders and 13 community health service managers working in child and family policy and planning or child and family community-based services. Interviews were of 30-60 min duration and explored stakeholder knowledge, perspectives and experiences around childhood adversity, and barriers and enablers to operationalizing policies supporting Hubs. Analysis of barriers and facilitators to implementation of Hub models of care was undertaken using the Consolidated Framework for Implementation Research (CFIR). RESULTS: Key barriers that emerged included short-term and inconsistent funding, lack of resourcing for a Hub co-ordinator, limited support for evaluation and insufficient time to plan for Hub implementation. Key enablers included flexibility and adaptability of Hub models to meet local needs, formal change management processes, strong governance structures and engagement among Hub practitioners. Key insights included the importance of targeted strategies to support sustained individual practice change and the need for organization-wide commitment to enable the successful adoption and maintenance of the Hub model of care. CONCLUSIONS: This study provides valuable insights and contributes evidence around what is needed to strengthen and support the operationalization and scalability of the Hub model of care. Key recommendations for Hub practitioners include the importance of formal change management processes and establishment of strong governance structures, while key recommendations for policymakers include the need for sustainable Hub funding and a standardized, evidence-based framework to support Hub implementation and evaluation.

Theory of change for addressing sex and gender bias, invisibility and exclusion in Australian health and medical research, policy and practice.

Sex and gender are inadequately considered in health and medical research, policy and practice, leading to preventable disparities in health and wellbeing. Several global institutions, journals, and funding bodies have developed policies and guidelines to improve the inclusion of diverse participants and consideration of sex and gender in research design and reporting and the delivery of clinical care. However, according to recent evaluations, these policies have had limited impact on the inclusion of diverse research participants, adequate reporting of sex and gender data and reducing preventable inequities in access to, and quality provision of, healthcare. In Australia, the Sex and Gender Policies in Medical Research (SGPMR) project aims to address sex and gender bias in health and medical research by (i) examining how sex and gender are currently considered in Australian research policy and practice; (ii) working with stakeholders to develop policy interventions; and (iii) understanding the wider impacts, including economic, of improved sex and gender consideration in Australian health and medical research. In this paper we describe the development of a theory of change (ToC) for the SGPMR project. The ToC evolved from a two-stage process consisting of key stakeholder interviews and a consultation event. The ToC aims to identify the pathways to impact from improved consideration of sex and gender in health and medical research, policy and practice, and highlight how key activities and policy levers can lead to improvements in clinical practice and health outcomes. In describing the development of the ToC, we present an entirely novel framework for outlining how sex and gender can be appropriately considered within the confines of health and medical research, policy and practice.

"This can certainly work ": stakeholder perspectives of the feasibility of a caregiver-led training program for caregivers of children with cerebral palsy in a rural setting in Malawi.

Introduction: Caregiver training is a key component of rehabilitation for children with complex lifelong disabilities such as cerebral palsy. However critical shortages of therapists in low- and middle-income countries like Malawi, reduce access to therapy. Introducing expert caregivers to assist with the provision of basic training on the condition for fellow caregivers offers a potential solution. However, there is a paucity of evidence regarding the implementation of such strategies in low-resource settings. The aim of this study was to explore perspectives of stakeholders regarding the feasibility of implementing a caregiver-led and delivered training program for caregivers of children with cerebral palsy in Malawi. Methods: Over 5 days in January 2023, a caregiver-led training program, the "Malamulele Onward Carer-to-Carer Training Program," was conducted in Blantyre, Malawi. A South African master trainer traveled to Malawi and delivered the program to potential stakeholders including caregivers of children with cerebral palsy; physiotherapists; and community-based organization representatives. Stakeholder perspectives regarding the acceptability, demand, practicality and adaptation of the program were obtained through a combination of focus group discussions, in-depth interviews, and daily field notes. Data from the focus group discussions and in-depth interviews were analyzed using thematic analysis. Results: The caregiver-led training program was deemed acceptable despite two areas identified as potential areas of concern; that the expert caregivers may cross practice boundaries and that their fellow caregivers may look down upon them. A demand for this program was expressed because of perceived relative advantages and relevance to caregiver needs. Participants indicated that the intervention could be easily delivered using local materials, absorbed and supported by existing community structures. Conclusion: A caregiver-led training program offers an innovative way of supporting caregivers of children with complex disabilities such as cerebral palsy in low-resource settings. The stakeholder engagement demonstrated the positive perspectives of all stakeholders. The areas for modification and adaptation highlighted by the stakeholders will be useful in strengthening the implementation of the program in Malawi.

Palliative care national plan implementation through stakeholder analysis.

BACKGROUND: National palliative care plans depend upon stakeholder engagement to succeed. Assessing the capability, interest, and knowledge of stakeholders is a crucial step in the implementation of public health initiatives, as recommended by the World Health Organisation. However, utilising stakeholder analysis is a strategy underused in public palliative care. OBJECTIVE: To conduct a stakeholder analysis characterising a diverse group of stakeholders involved in implementing a national palliative care plan in three rural regions of an upper-middle-income country. METHODS: A descriptive cross-sectional study design, complemented by a quantitative stakeholder analysis approach, was executed through a survey designed to gauge stakeholders' levels of interest and capability in relation to five fundamental dimensions of public palliative care: provision of services, accessibility of essential medicines, palliative care education, financial support, and palliative care vitality. Stakeholders were categorised as promoters (high-power, high-interest), latent (high-power, low-interest), advocates (low-power, high-interest), and indifferent (low-power and low-interest). Stakeholder self-perceived category and knowledge level were also assessed. RESULTS: Among the 65 surveyed stakeholders, 19 were categorised as promoters, 34 as advocates, 9 as latent, and 3 as indifferent. Stakeholders' self-perception of their category did not align with the results of the quantitative analysis. When evaluated by region and palliative care dimensions the distribution of stakeholders was nonuniform. Palliative care funding was the dimension with the highest number of stakeholders categorised as indifferent, and the lowest percentage of promoters. Stakeholders categorised as promoters consistently reported a low level of knowledge, regardless of the dimension, region, or their level of interest. CONCLUSIONS: Assessing the capability, interest, and knowledge of stakeholders is a crucial step when implementing public health initiatives in palliative care. It allows for a data-driven decision-making process on how to delegate responsibilities, administer financial resources, and establish governance boards that remain engaged and work efficiently.

What leadership role should University Medical Centers take in regional primary prevention networks? An interdisciplinary, multi-method analysis of a crowded stakeholder environment.

Advancing public health through prevention necessitates collaboration among public, private, and community actors. Only together can these different actors amass the resources, knowledge, and community outreach required to promote health. Recent studies have suggested that university medical centres (UMCs) can play a key role in regional prevention networks, given their capacity to initiate, coordinate, drive, and monitor large partnerships. Yet, the literature often refers to prevention activities in general, leaving underexplored what UMCs can add to primary, universal prevention networks specifically. Moreover, UMCs operate in a crowded field of other organizations with extensive experience in primary prevention, who will already have an idea about what role UMCs should play in the network. This article presents a case study examining the potential role of a UMC within a densely interconnected stakeholder environment in the surroundings of a large city in the Netherlands. Combining insights from public health studies and network governance research, and integrating data from various methods, this study concludes that UMCs can enhance their contributions to prevention by assuming the role of network servants rather than network leaders. Stakeholders consider public health authorities or municipal governments as more logical candidates for coordinating the network. Moreover, partners often perceive-deservedly or not-UMCs as overly focused on the medical aspects of prevention, potentially neglecting social interventions, and as favouring universal treatments over tailor-made community interventions. At the same time, partner organizations hope that the UMCs join collaborations within the community, using their expertise to measure the impact of interventions and leveraging their prestige to generate attention for primary prevention. By synthesizing theoretical insights from multiple disciplines and analysing the empirics of network leaderships through multiple methods, this study offers UMCs a contextually-informed perspective on how to position themselves effectively within primary prevention networks.

2021 Community Engagement Studio Virtual Training Summit: Increasing the Diversity of Stakeholders Engaged in Research.

BACKGROUND: There are few methods that focus on engaging racial and ethnic minorities in research. The Meharry-Vanderbilt Community Engaged Research Core partnered with the University of Utah, the University of Michigan, and community/patient partners to convene a virtual summit to share the Community Engagement Studio (CE Studio) model, a structured and widely-used approach that facilitates community engagement in research. OBJECTIVES: The CE Studio Virtual Training Summit (Summit) goal was to prepare multi-stakeholder (e.g., researchers, community members) research teams to engage more racial/ethnic minorities in CE studios. METHODS: Summit planning included (1) agenda development, including CE Studio training and a live CE Studio demonstration; (2) summit advertisement across several networks, including minority-serving institutions; and (3) development of pre-and post-Summit evaluations. RESULTS: Among 50 registrants (76.7% academicians) that completed evaluations, more than 65% planned to increase engagement of racial/ethnic minorities in research and implement CE Studios as a result of the Summit. Increased confidence in all CE training areas was reported, including in conducting an effective CE Studio planning meeting (32.1% pre-Summit/90.3% post-Summit) and identifying and preparing patient/community stakeholders for engagement as CE Studio experts (46.4% pre-Summit/93.6% post-Summit). CONCLUSIONS: Virtual CE Studio training that includes multi-stakeholder planning partners can be an effective method for introducing the CE Studio model and preparing multi-stakeholder research teams to engage racial and ethnic minorities in CE Studios. This is particularly salient given that effective community engaged research methods and best practices are not currently being distributed through research programs at a pace consistent with the demands.