Involving people and next of kin as patient partners in research can enhance research quality. Training researchers seems to be an effective way to support meaningful involvement of patient partners. Although guidance is increasingly available, Danish researchers lack support for implementing patient partner involvement. Providing a dedicated training programme for researchers could help them establish meaningful partnerships with patient partners. This study aimed to develop and evaluate the feasibility and acceptability of a training programme designed to assist researchers in involving patient partners. The training programme was co-produced by researchers and patient partners, who are referred to as patient partner teachers. The development and feasibility phases were guided by the Medical Research Council's framework for developing complex interventions and structured according to the six parameters of the didactic relationship model: 'prerequisites for learning', 'learning goals', 'settings and conditions', 'learning process', 'educational content', and 'evaluation of learning'. Feasibility and acceptability were assessed through questionnaires completed by participants before, during, and after the training programme. The didactic relationship model provided a strong pedagogical basis for developing a training programme. The co-production process was effectively managed, with patient partner teachers reporting feeling involved throughout the project, especially in communication and partnership within the development team. A total of 32 participants, including researchers with various job titles, attended the training. Most participants indicated they had extensive research experience but limited knowledge of and confidence in involving patient partners. The training programme - which was customised to meet the needs of diverse participants and delivered in small groups - proved beneficial, boosting their confidence. Overall, the participants expressed satisfaction with the programme and enthusiasm for the patient partner teachers, and 85% would recommend the training to a colleague. This training programme was feasible and addressed participants' needs. The co-production process was essential for both developing and delivering the training. Future research should examine additional factors that encourage meaningful involvement of patient partners in the research process. Including patients and next of kin as research partners can improve the results and make them more relevant to the people they are meant to help. Research conducted with patients and next of kin as patient partners can improve the quality and relevance of research results. Training researchers in this partnership can make the involvement more effective. But researchers do not usually get this kind of training as standard. Training can help researchers meaningfully involve patients and relatives in their projects. This study aimed to develop training and test whether researchers who got the training thought it worked. Two patient partners were a part of developing and delivering the training as patient partner teachers. They reported feeling included in the development process and expressed high satisfaction with communication and teamwork. A total of 32 researchers with different areas of work took part in the training. They filled in questionnaires before, during, and after the training to share their views. Although most researchers had more than 10 years of research experience, they initially reported less experience and confidence about including patients and next of kin in their work. Overall, the researchers who did the training thought it was helpful and liked having the patient partner teachers doing some of the teaching. Inviting a small group of researchers from different backgrounds to take part of the training worked well. Most said they would recommend the training to others. Future research should investigate how other things can help researchers to involve patient partners meaningfully.
There are very few reports of patient and public involvement (PPI) initiatives in cardiovascular disease research and even fewer in heart failure, the eventual end point of many cardiovascular conditions. This report describes and critically appraises a PPI endeavor conducted during a programme of work focused on designing a multi-component diet and exercise intervention for people with Heart Failure with preserved Ejection Fraction (HFpEF). This is a retrospective analysis and critical reflection of field notes and formal communication documents (produced during PPI meetings, n = 3) and transcripts (produced during workshops, n = 3) collected throughout the HFpEF research programme (PRESERVE-HFpEF). PPI had a substantial effect on this project both in terms of the content of the intervention and on the researchers' perceptions and skills in conducting meaningful PPI. For example, the dietary interventions envisioned within the intervention (caloric restriction, low carbohydrate and high protein), which were based on a meta-analysis of effects we (the authors) performed, were not deemed to be appealing nor feasible by PPI contributors. Many of the researcher related learning points we identified during the analysis, for example practical arrangements that maximize participation, allowing for more open dialogue and being mindful of scientific biases, were not obvious until they were subjected to an interrogative 'critical' process. To build a foundation of good practice and evidence of the potential impact of PPI in cardiovascular disease research, we need further descriptions of the involvement process. This reflection is one of very few reports describing how PPI was enacted in heart failure research and what the impacts were. We hope that it will provide other researchers with some insight into how (or how not to) approach and deliver PPI in their research journey. Not applicable. People with heart failure with preserved ejection fraction were involved throughout the lifespan of this project. They participated in the PPI meetings and workshops where the direction of the research was discussed and their opinions and expertise were sought, initially through consultation type methods and later via consultation with co-production overtones. One member (JS) contributed to data analysis and interpretation; and provided critical feedback on emerging ideas and drafts of this report. In this paper the researchers think back on the patient involvement activities they have conducted as part of a study that tried to create a new diet and exercise intervention for people with Heart Failure with preserved Ejection Fraction (HFpEF). HFpEF is the most common type of heart failure. It can be very difficult to diagnose and manage as the symptoms impact on quality of life and there are few treatment options. There is some evidence that suggests combined diet and exercise interventions can be beneficial to people with HFpEF, although the optimal combination remains unclear.People with HFpEF who had been taking part in an ongoing study, were asked to contribute to the development and design of a combined diet and exercise intervention called PRESERVE-HFpEF. The researchers explain what they did to engage with people with HFpEF to shape the research idea and design of the intervention, and consider how their approach could be improved. They also explore what other researchers have said about involvement, and use this to show the weakness of their methods, or where they could have approached things differently.This story of patient involvement shows how important good and meaningful involvement is, and the researchers explain how they missed opportunities to identify a very important belief that patients with HFpEF held. This belief was that diet intervention styles identified by a study of studies (meta-analysis), did not appeal to them and they would be unlikely to either take part in, or stick with, any future intervention that included these designs. This viewpoint, once realized, led to a complete change to the intervention. The contributor informed design focused on recommendations for small changes in shopping and eating habits that could be more easily achieved within everyday life, rather than having to follow complicated and detailed diet prescriptions.
Despite growing calls for patient and public involvement (PPI) to improve research relevance and inclusivity, it is still too often implemented in a tokenistic way. Health inequalities persist, and vulnerable populations, such as people with chronic conditions and/or limited health literacy (LHL), remain underrepresented as active participants in research. Factors contributing to this underrepresentation include complex research language, unfamiliar settings, and social stigma. To bridge the gap, this study aims to offer practical lessons that provide researchers and policymakers with concrete strategies for creating inclusive and effective research collaboration processes. A participatory action research approach was used, guided by the first three stages of the Participatory Research to Action (PR2A) framework: readiness, discover, and define. Data were collected across five group sessions with ten individuals with type 2 diabetes and various health literacy levels. The analysis focused on process-related data to explore recruitment, facilitation strategies, and participatory experiences. Effective recruitment relied on a multifaceted community outreach approach, combining online and offline channels, which improved group diversity. Clarifying expectations at the outset and balancing structure and flexibility supported meaningful contributions, and allowed sessions to be adapted to individual needs. This approach fostered factors central to motivation and group cohesion, including a collective purpose and mutual respect, while recognising the varied experiences of managing diabetes. Equitable engagement between citizen researchers and PPI facilitators was essential to valuing diverse perspectives and maintaining shared responsibility. Creative co-creation strategies, including sketching and small-group exercises, proved more effective in promoting accessible, inclusive engagement than text-based or plenary-only methods. The study demonstrates that recruiting and engaging citizens with type 2 diabetes and various health literacy levels as citizen researchers is feasible when conditions such as equitable partnership and engagement, clear expectations, and flexible structures are met. Creative co-creation strategies further support accessible and meaningful participation. These insights provide practical guidance for researchers seeking to implement inclusive PPI, contribute to reducing health inequalities, and inform the next stages of the PR2A framework for advancing participatory health research. The online version contains supplementary material available at 10.1186/s40900-026-00873-w. More and more researchers understand that it is important to do research together with people who have chronic conditions. Unfortunately, it still happens too often that they are not listened to enough and are not allowed to help make decisions. This is especially true for people in a vulnerable position, such as people with chronic conditions and people who find it difficult to find, understand, and use health information. Two researchers brought together ten people with a chronic condition (type 2 diabetes). They form a group that shares experiences and talks about what they feel is lacking in their diabetes care. This article describes how to start such a group and how this group can meaningfully participate in research. To find people with a chronic condition, researchers can go to places where they often spend time. Current group members can also encourage others to join. During the five meetings, the group spent a lot of time getting to know each other. This helped everyone feel free to share their thoughts about the group and the group process. It is important that researchers spend enough time creating an open and safe environment, setting clear expectations, and treating each other with respect. Depending on who is in the group, the language used must be adjusted. In this way, people with chronic conditions can take part in research and share their opinions. By doing research together with people in a vulnerable position, we hope to improve healthcare. See Additional file 1 for the Plain Dutch summary.
Effective knowledge mobilization (KM) and meaningful partnerships can improve research relevance, quality, and impact. While guidance for effective KM tool development and successful research partnerships exists, practices are not consistently described or evaluated. To address this gap, we applied a mixed-methods approach to (i) describe and evaluate a set of tailored KM tools and (ii) assess parent-partnership, within a study on caregiver recruitment networks. A custom survey, distributed to participants of the primary study, was used to evaluate KM tools. The Public and Patient Engagement Evaluation Tool 2.0© survey, and a facilitated discussion, was used to evaluate research partnership. Evaluations were conducted in year two of the two-year project. Quantitative data were analyzed descriptively. Qualitative feedback underwent directed content analysis followed by inductive analysis. Data were integrated during analysis and interpretation. KM tool evaluation: Participants reported that their views were adequately reflected in each KM tool, and they were likely to recommend the tools to others. Important messaging, clarity, and visual appeal were noted as positive features across tools. The lay summary and tip sheets were concise, easy to read, yet still full of information. The painting series was described as engaging and emotionally evocative, prompting reflection on one's personal experience and drawing out feelings of "hope, partnership, and a journey". Participants provided tangible feedback on missed messages in the KM tools, or where additional emphasis or clarification was needed to support accuracy. Partnership evaluation: All team members were satisfied with their involvement. Data within the category of "What went well" highlighted knowledge gained, and personal and team-level qualities (humility, balance, honesty, positivity). The category of "What could be improved" drew attention to systemic barriers to sustained partnership (time, finances, and logistics), and lack of diversity within the team. Involving primary participants in KM tool evaluation ensured message accuracy and highlighted the unique power of arts-based KM to evoke emotional resonance. Future research should consider integrating arts-based methods to complement traditional KM tools to enhance engagement with research findings. High partner satisfaction suggests that strong relational foundations can mitigate common logistical pitfalls in research partnerships. Parent-partnership in research, and the need for tools to share research findings, are recognized as important parts of conducting meaningful and impactful research. In a previous study our team, which includes parent partners and researchers, explored the experiences of parent partners who have been asked to use their personal networks to help recruit for research. Based on what we learned from the parent partner participants, we then created tools to share these insights with more people. These tools included a plain language summary, tip sheets for both researchers and for parent partners, and three paintings with write-ups that linked to the three themes uncovered in the study. We then developed a study to evaluate (i) what participants thought of each of the knowledge sharing tools, and (ii) how our team of researchers and parent partners worked together. These evaluations are the focus of the current paper. The feedback that participants provided on the knowledge sharing tools indicated that the lay summary and tip sheets were concise, easy to read, yet still full of information. The painting series was described as engaging, encouraging reflection, and evoking feelings of “hope, partnership, and a journey”. Participants provided feedback on key messages that were missed in the tools as well as where additional emphasis and clarification was needed. This feedback helped us correct and improve these information sharing methods before we released them to the public. We discovered that all research team members were satisfied with their involvement in the collaboration. Our team found that having humility, balance, honesty, and positivity went well when working together. Areas for improvement included time, finances (e.g., compensation), and logistics (e.g., role clarity, decision making). When research teams conduct evaluations on knowledge sharing and partnerships, the team can improve their research outputs and teamwork. We share our findings to encourage other teams to build evaluations into their projects, with the goal of enhancing partnerships and research impact.
Family engagement in mental health service reform, design, treatment, and research is highlighted as important within government and governance guidelines; however, inconsistencies of inclusion continue to be experienced and reported. Within mental health and community research there are calls for the adoption of participatory and co-production methodologies. To add to the informed debate about patient and public involvement and engagement, this article explored the value, outcomes, and benefits of co-production as a way of working with and elevating mental health family carers in research. Thirteen family carer co-researchers participated in one of two focused-conversations alongside two university academics, to reflect upon their experiences of working together across a 9-month co-produced research project. Co-researchers were asked to consider experiences in relation to the meaning of participation, impacts of co-production, and how this co-produced research compared to involvement in other research. The co-researchers were invited to participate in co-analysing the focused-conversations transcriptions, determining the findings, and authoring this paper. Utilising an inductive approach to reflexive thematic analysis, insights into the values and benefits for family carers, academic researchers, research evidence, and outcomes were established. Themes developed about the values and benefits as well as the mechanisms of co-production. Benefits were indicated for the researchers, participants, research process, evidence and outcomes. Mechanisms in relation to people's experiences of co-production included: processes were different to other research experiences, practices were relational, and ethos was collegial and supportive. The value of co-production was seen as privileging family carer voices, creating a sense of community and 'sitting around the kitchen table', leading to belonging and sharing within a space where people were safe, and participants felt validated. In recognising that co-production is fundamentally different to traditional research, this paper revealed the value, outcomes, and benefits of processes, practices and ethos that engaged and elevated family carer leadership in research. Family carer co-researchers experienced feelings of increased capability and identified that co-production, is right if the end result resonates with the whole experience.
Xenotransplantation (XT) is being explored as a potential solution to organ shortages. Driven by revived scientific interest, XT has sparked debates that remain ethically charged. While much literature focuses on why community engagement is needed, this paper examines how XT itself reshapes the public involvement. We reflect on collaboration between researchers and public contributors during development of a national survey on UK public attitudes towards XT. Co-written by researchers and contributors, the paper draws on meeting notes and email exchanges to examine how XT shaped group dynamics. We argue that XT is not only a biomedical innovation but also a disruptive force in public involvement in research in three ways. First, as a distant prospect, it permits asking philosophical rather than merely practical questions. Second, its scientific uncertainty may unsettle the expert-public divide, fostering shared curiosity and speculation. Third, XT's emergent status makes visible how research may shape what XT becomes. Working on the development of the survey, we were thus not only engaging with XT's content but also reflecting on their role in its unfolding. Our reflections highlight how focus on technologies that remain in exploratory phases can reshape researcher-contributor dynamics by flattening hierarchies. While often framed through technological determinism, XT was instead experienced as contingent, something open to questioning, negotiation, and resistance. Rather than being the sole domain of experts, it appeared amenable to influence through research and public involvement. XT, being a novel and controversial technology, unsettles conventional models of public involvement in research, opening new possibilities for participation and challenging assumptions about its purpose and dynamics. There is a persistent global shortage of organs for transplantation that leads to long transplant waiting lists and thousands of deaths each year. One potential solution to this shortage being explored is xenotransplantation (XT), which is the transplantation of living cells, tissues, or organs from animals into humans. Current research focuses on the use of genetically engineered kidneys and hearts from pigs for transplantation. Here, we reflect on collaboration between researchers and public contributors during development of a national survey on UK public attitudes towards XT. We argue that the topic of XT, by being novel and controversial, can reshape familiar dynamics of public involvement and open up new avenues for participation. Firstly, in our experience, the topic gave an opportunity for public contributors to steer the conversation away from the more practical matters (e.g., wording of the survey) to address philosophical questions (e.g. whether humans have the right to use animals to extend human life). Secondly, because of the scientific uncertainty surrounding XT, researchers felt often out of their depth. This disrupted, the often-felt in public involvement, expert–public divide. Thirdly, the novelty of XT, made it apparent how research might shape what XT becomes. Therefore, public contributors were not only engaging with the content of the survey but played a role in establishing what XT was becoming. XT unsettles conventional ways of public involvement in research. It may open new possibilities for participation and challenge assumptions about the purpose and dynamics of public involvement.
Patient and public involvement (PPI) is an expectation and requirement of health and social care research within the United Kingdom. Although there is available guidance on how to practice PPI, to date there have been no frameworks or resources available specifically for PPI in rapid evidence syntheses, where work can be completed in as little as two or three weeks. Our objective was to design a framework to support those doing rapid evidence syntheses to include PPI in their work. We developed the framework across three stages. First, we undertook a scoping review of published PPI frameworks in health and social care (N = 53) and a survey of key interest-holders (N = 101). The results of these alongside an online workshop with 15 interest-holders (researchers, members of the public, policymakers, PPI professionals) in November 2024 informed the initial development of the framework. We evaluated the draft framework at a second online workshop with 16 interest-holders in January 2025. We analysed the findings from this second workshop to further refine the framework. The Rapid Involvement of Patients and the PubLic in Evidence Synthesis (RIPPLES) framework guides PPI in rapid evidence syntheses through three interconnected layers: core guiding principles of the UK Standards for Public Involvement at the centre; building continued approaches to patient, public and community engagement; and steps for embedding PPI into individual rapid evidence synthesis projects. An accompanying guidance document and worksheet to plan PPI activities were also developed to aid researchers in using the framework. RIPPLES is the first framework to provide practical and pragmatic guidance on how to embed PPI within rapid evidence synthesis. The framework will undergo evaluation and refinement, including development of public-facing materials and case studies to supplement current resources. Rapid evidence syntheses are a type of research that brings together all the information about a specific topic to find out what it says overall. They sometimes need to be done in just a couple of weeks. We know involving patients and members of the public in evidence syntheses has benefits for the people involved and the research itself. However, researchers have not had guidance on how to involve people in rapid evidence syntheses. This is why we developed the Rapid Involvement of Patients and the PubLic in Rapid Evidence Synthesis (RIPPLES) framework. We developed RIPPLES by finding common features of already-published frameworks for patient and public involvement, doing a survey and holding two workshops with members of the public, researchers who do evidence syntheses and people who work in public involvement. We brought all three of these pieces of work together to co-develop RIPPLES. RIPPLES builds on the UK Standards for Public Involvement. It encourages researchers to develop relationships with members of the public and communities so they can start involvement in rapid evidence syntheses quickly. Finally, it gives researchers guidance on how to involve people in rapid evidence synthesis projects. The framework comes with a detailed guidance document with links to other useful information and a worksheet to help plan patient and public involvement in rapid evidence syntheses. RIPPLES will help researchers meaningfully involve patients and the public in rapid evidence syntheses. We will also evaluate it in future to make sure it continues to be useful.
Myanmar migrant workers in Thailand's seafood processing industry develop work-related musculoskeletal disorders from tasks such as repetitive shrimp peeling and standing for extended periods. These workers remain largely unreached by standard health interventions due to language barriers and cultural isolation. Developing effective study for this vulnerable population requires meaningful involvement of workers in the study design process, recognizing their experiential expertise while acknowledging the distinct roles of researchers and community members. This paper documents how involvement with stakeholders such as migrant workers themselves shaped the co-design of a study testing a culturally appropriate digital health intervention for managing existing symptoms and preventing progression of musculoskeletal disorders. This was a mixed-methods co-design study combining qualitative community engagement with quantitative expert validation. We conducted engagement sessions with 29 Myanmar migrant workers, organized into three groups by length of work experience (less than 2 years, 2-5 years, more than 5 years). We engaged 5 workplace stakeholders (human resource managers and production line supervisors) and consulted 4 international physical therapy experts for validation. Sessions were structured as conversations. Workers provided substantial input on intervention content, delivery methods, and practical requirements for the planned study. We accommodated their 12-hour work schedules, communicated in Myanmar language, and valued their experiential knowledge as essential for culturally appropriate study design. Thematic analysis identified key themes from worker input. Expert validators assessed the co-designed intervention using Content Validity Index (CVI) methodology. All participating workers reported hand symptoms including numbness, tingling, and pain. Workers expressed preferences for health information through platforms they used daily, with Facebook emerging as the clear preference over text-based materials or in-person workshops on their only day off. These insights shaped the study intervention: a 4-week intervention with 12 progressive exercises addressing observed strain patterns: forward-leaning postures and repetitive hand movements. Workers specified practical requirements such as exercises must function in small dormitory spaces, outside work hours, without equipment. The peer challenge format emerged from their suggestions about sustained engagement. The co-designed study intervention achieved strong content validity scores from expert validators (I-CVI: 0.95-1.00; S-CVI/Ave: 0.94). The engagement process also highlighted ethical considerations when working with vulnerable migrant populations, including managing power differentials and protecting workers from potential workplace repercussions. Workers possess essential knowledge about their needs and what works in their circumstances. We found that when research incorporates the input of the intended beneficiaries in study design, the result is a study intervention that is both clinically appropriate and practically usable. The co-designed intervention is now used for evaluation in the implementation research. This paper contributes a documented methodological approach to community involvement with a vulnerable migrant population, demonstrating that structured engagement can produce interventions meeting both worker feasibility requirements and clinical validity standards, while generating an honest account of the ethical tensions such work entails. WHAT IS THE PROBLEM?: Myanmar migrant workers in Thailand’s seafood industry perform repetitive tasks like shrimp peeling while standing for long hours. This leads to pain in their hands, necks, backs, and other body parts. Language barriers, limited healthcare access, and demanding work schedules make it difficult for these workers to get help or learn how to prevent these problems. WHAT DID WE DO?: We worked directly with 29 Myanmar workers, workplace managers, and physical therapy experts to design a study that would test a health program on addressing pain in their hands, necks, backs, and other body parts specifically for this community. We sought input from workers to help shape the study based on what would actually work in their daily lives. We asked about their pain, their access to healthcare, and how they prefer to receive health information. WHAT DID WE FIND?: Every worker we spoke with experienced hand symptoms, and many also had neck, back, or leg pain. Workers told us they prefer getting health information through Facebook videos they can watch during their limited free time, rather than attending workshops on their only day off. They wanted short, practical exercises they could do in their dormitories without special equipment. We also encountered some ethical issues, including ensuring workers felt safe to speak honestly without fear of workplace consequences and addressing the power imbalance between researchers and workers in the co-design process. WHAT DOES THIS MEAN?: By involving stakeholders including migrant workers themselves in designing this study, we created a Facebook-based program with simple exercises and health tips tailored to their needs that is now ready to be tested in a future study. We describe how migrant workers can be effective contributors in developing study that address their unique challenges, and digital platforms offer a practical way to reach people with demanding work schedules.
Undergraduate research engagement plays a pivotal role in promoting evidence-based medical practice, particularly in low-resource and conflict-affected settings such as Yemen. However, multiple structural and academic barriers often limit students' ability to actively participate in research. This study aimed to assess medical students' research knowledge, attitudes, participation, and perceived barriers in a multi-institutional setting in Yemen. A cross-sectional survey was conducted among undergraduate medical students from ten universities in Yemen using a structured online questionnaire assessing research knowledge, attitudes, participation, and perceived barriers. Data were collected between April and July 2025. Statistical analyses included descriptive statistics, independent t-tests, one-way analysis of variance, and linear regression to identify factors associated with research knowledge and attitudes. A total of 1,387 students participated in the study, with a mean age of 23 years; 70.7% were male. Although most students (79.8%) agreed that research should be an integral part of medical education, only 20.5% reported having published a research paper, and 41.5% had never attempted to write one. The mean research knowledge score was low (2.8 out of 10), with no significant difference by gender. Fifth-year students demonstrated the highest knowledge scores (mean = 3.2, SD = 2.0; p = 0.003). Academic performance was a significant predictor of both research knowledge and attitudes (p < 0.001). The most frequently reported barriers were insufficient training in research methods (81.0%), inadequate research facilities and resources (76.0%), limited research opportunities (74.2%), and insufficient faculty guidance (72.3%). Participating medical students demonstrated generally positive attitudes toward research; however, their research knowledge and active involvement remained limited. Persistent institutional and structural barriers, including limited research training, mentorship, and infrastructure, may hinder meaningful research engagement. Strengthening research training and institutional support within undergraduate medical education may help improve research engagement in resource-limited and conflict-affected settings.
Patient engagement, in which patients and their caregivers work together with research teams, can enhance the relevance, quality, and applicability of health research findings. While patient engagement has been successfully integrated into many areas of health research, its application within health economic evaluations remains limited. This commentary explores interest and strategies for patient engagement in economic evaluation, based on our work with 5 patient partners and 12 research centres affiliated with the Ontario Strategy for Patient-Oriented Research SUPPORT Unit (OSSU). We also piloted a co-production approach to develop practical tools and strategies for meaningful engagement. Both patient partners and OSSU centre representatives emphasized the need for clear guidance, targeted training, and sustained investment to enable scalable and equitable engagement in this complex area of research. Key barriers identified included a lack of plain-language resources, limited institutional capacity for facilitating patient partnerships, and the absence of centralized supports across OSSU research centres. Through a series of virtual meetings between patient partners, we co-created a visual flow diagram and a patient activity matrix to support engagement across key stages of economic evaluation. The engagement process was grounded in shared learning, respect for lived experience, and responsiveness to evolving priorities. Our work supports the growing literature on patient engagement in health economics and offers early evidence that co-developed tools can support inclusive, patient-informed economic evaluations. Our findings lay the groundwork for future efforts to create targeted and practical guidance on when and how to embed patient perspectives throughout the economic evaluation process, thereby contributing to more transparent, collaborative, and equitable health policy decision-making. Health economic evaluations are studies that help to decide how to use limited healthcare resources fairly and effectively. They compare the costs and benefits of different treatments or health technologies to identify which options provide the greatest value. Although people with lived experience, such as patients and caregivers, have valuable knowledge about living with illness and navigating healthcare, they are rarely involved in creating these studies. To better understand why patients are infrequently included, we held discussions with researchers specializing in patient engagement in Ontario, Canada, and five patient partners from across the country. Both groups identified uncertainty about when and how to involve patients as a key barrier to meaningful collaboration. In response, researchers and patient partners worked together to develop two tools to support collaboration in economic evaluation projects. These include a visual diagram that explains the main steps of an economic evaluation in plain language and a table that offers suggestions on when and how patients should be involved at each step. These tools aim to make economic evaluations easier for patients to understand and encourage researchers to include patients in their work. Future work will build on this foundation to develop clearer guidance for researchers on how to collaborate effectively in economic evaluations.
Patient and Public Involvement and Engagement (PPIE) is integral to ensuring health research remains grounded in patient priorities and lived experience. This is especially critical for underrepresented groups, such as adults aged 90 and over considering elective total hip replacement (THR). This demographic experiences a small but meaningful risk of postoperative mortality, yet conventional numeric risk communication often fails to align with their values, communication preferences, and the existential context of very advanced age. Traditional PPIE methods, like focus groups, may inadvertently exclude this group due to sensory, mobility, or digital barriers. This PPIE activity engaged eight public contributors aged 90-96 years with lived experience of total hip replacement or caring for someone who underwent it (including two carers) through semi-structured one-to-one telephone conversations, aligned with the GRIPP2 Short Form and UK Standards for Public Involvement. We detail our approach to building rapport and facilitating nuanced conversations remotely, focusing on three domains: research context, communication preferences, and decision-making. Our methodology was designed to prioritise relationship-building and flexibility to overcome barriers to participation. Inductive review of facilitator notes identified three central themes: 1.A Pragmatic Conceptualisation of Risk: Participants framed mortality risk as an acceptable "chance you take," shaped by life experience and advanced age.2.Values-Based Decision-Making: Quality of life outcomes: mobility, independence, and maintaining an optimistic outlook were prioritised over longevity alone.3.The Imperative for Compassionate Communication: Participants emphasised a need for clear, respectful, and multi-modal communication, while explicitly rejecting ageist or overly clinical language. Contributors unanimously affirmed the importance of this topic, feeling that as an underserved community, their perspectives on mortality were both valuable in decision making and long overdue. This PPIE activity involved a small number of contributors and used telephone-only engagement. While this ensured accessibility, it may limit transferability to other contexts. Future work should test alternative formats and include larger, more diverse samples to enhance generalisability to the nonagenarian populations. Nonetheless, the rich feedback insights from this unrepresented group provide a valuable foundation for future work. The findings challenge the primacy of numerical risk presentation for this demographic, underscoring that communication must prioritise dignity, optimism, and clarity. Crucially, contributors affirmed that discussing mortality is a necessary part of informed consent, countering assumptions that this topic should be avoided. These insights directly inform more sensitive and relevant research design and clinical communication tools, ensuring they are grounded in the values and priorities of the patients they are meant to serve. This project involved talking directly to eight contributors aged 90 and over — including people who had undergone total hip replacement (THR) and their carers — to understand their views on the risk of dying from this operation. THR can greatly improve mobility and quality of life, but it carries a small risk of death. Patients and families need this information explained clearly and sensitively. We spoke individually with each contributor by telephone. They told us that:They see the risk of surgery as a normal part of life.Improving their quality of life, by reducing pain and keeping them mobile, is more important than just living longer.Doctors should talk about the risks of hip replacement honestly, respectfully, and using simple words and pictures.The contributors felt they were part of an age group that is often underrepresented and overlooked in healthcare, making their input especially valuable. Their feedback is being used to create better information leaflets and communication guides, ensuring that future patients and their families can have supportive and understandable conversations about surgery.
A core tenet of implementation science is early planning for implementation with invested partners. For health systems, aligning workflows and strategies to the local context and ensuring that the intervention's change mechanism meets local priorities are critical for successful implementation. This paper describes a participatory engagement method to design and adapt cancer prevention and control tools (interventions) to promote whole-health and aligned workflows and strategies, focusing on health equity, termed Co-creation for health equity (CO-4 Health Equity). We illustrate this novel method with primary care (prevention) and oncology (treatment) case examples. The CO-4 Health Equity method included a set of parallel online workshop sessions with clinic providers/staff and patient partners. This method is guided by the Core Functions and Forms approach to the implementation of complex interventions. That is, we actively worked with partners to co-create clinical workflows and other activities (i.e.,. the intervention's forms) that were tailored to clinical contexts, while preserving the intervention's core function(s), linked to how the intervention brings about change. Through four to five sessions, participants identified and refined the intervention's core purposes (functions) to ensure alignment with clinic priorities. Sessions focused on refining and adapting concrete forms (how) to meet those functions, such as clinical workflows and implementation strategies. We used similar co-creation methods in primary care and oncology settings. In primary care and oncology, patients and clinical partners with diverse roles across clinics (e.g., clinicians, nurses, care managers, medical assistants, operations leaders, and electronic medical records informaticists) participated in 45-90-minute co-creation workshops. Sessions with clinic partners (n = 13 primary care partners; n = 15 oncology partners) and patients (n = 5 primary care patients; n = 7 oncology patients) were held separately and included summaries of patient recommendations and vice versa. Sessions focused on: (1) refining the core goals of each tool (e.g., identifying patients' priority cancer risk factors); (2) refining and adapting the workflows and strategies for intervention delivery; (3) user testing of tool prototypes; and (4) consensus-building on options for clinical workflows. We used iPRISM webtool for implementation planning, and developed matrices to track actions taken in response to partner recommendations. This CO-4 Health Equity methodology leverages input from invested partners to refine and adapt workflows and strategies for implementing cancer prevention and control tools in primary care and oncology settings. Future directions include further testing this participatory methodology and applying it to other clinical innovations to increase health equity. A growing field in research takes projects that have shown positive impact in a lab and focus on their delivery into a real-world setting, such as in a medical clinic. This field is called implementation science. It is known that for a new project to be successful in a new setting, individuals who deliver that project and those who benefit from it need to provide their thoughts and actively work with researchers on how the project is set up in local contexts. These individuals are called invested partners, and include doctors, nurses, medical assistants, clinical office staff, and patients. This paper describes a novel way, or method, of engaging with invested partners called Co-creation for health equity or CO-4 Health Equity. The method used separate meetings, or workshops, for clinical staff and patients. Partners provided their thoughts on the project during four or five workshops. Each workshop was on a different area of the project and were facilitated by the research team. This paper describes the CO-4 Health Equity in two different medical clinics. The first type of clinic was a primary care clinic where the research team was introducing a patient questionnaire for cancer prevention purposes. The second type of clinic was a cancer clinic where the research team was introducing an aging patient questionnaire. The CO-4 Health Equity method provided a road map for researchers to engage with invested partners, and an opportunity for partners to share their preferences and priorities so projects can be better for them.
Regional economic disparities in the United Kingdom lead to large differences in health. Previous attempts to address this issue have had limited success. Community Wealth Building is an economic strategy that aims to address these inequalities by redirecting wealth back into the local economy and increasing community control over the economy. The City of Preston initiated a Community Wealth Building strategy in 2012. We investigate the health impact of this approach in Preston up to 2019, a period during which their strategy largely focused on progressive procurement and the adoption of the Living Wage by employers within Preston. We estimate the impact of Community Wealth Building in Preston on mental health problems as measured by the Small Area Mental Health Index and its constituent components (antidepressants, depression diagnoses and mental health-related hospital attendances), self-reported life satisfaction, wages, employment and the number of non-profit enterprises. We use matching and difference-in-differences analysis to compare changes in outcomes in Preston before and after the intervention with changes in the outcomes in comparison areas. We use data on invoices and contracts issued by local authorities to compare procurement by Preston City Council with other similar local authorities, assessing the impact of local procurement on employment, wages and the cost of contracts. Finally, we use a combination of interviews and workshops to understand the process of change that has taken place in Preston and what has helped or hindered this. We found that, in Preston, the introduction of Community Wealth Building was associated with a reduction in mental health problems (-0.11 reduction in Small Area Mental Health Index, 95% confidence interval -0.16 to -0.06) alongside improvements in life satisfaction (0.06, 95% confidence interval 0.01 to 1.3), wages (£38 per week, 95% confidence interval £6.8 to £62.1), employment (4.1%, 95% confidence interval 2.3% to 5.8%) and a growth in non-profit enterprises (additional 20 enterprises 95% confidence interval 6 to 50). These economic improvements tended to be greatest among more disadvantaged groups, reducing inequalities. Preston City Council was much more likely to procure services from local suppliers compared to other similar local authorities, and this practice is likely to have contributed to these economic benefits. We found no evidence that procuring locally increased costs. Stakeholders in Preston highlighted that economic pathways to health impact were the most developed particularly in relation to procurement policy, while the community pathways to impact were less developed. Lack of widespread public involvement and engagement with smaller Voluntary, Community, Faith and Social Enterprise organisations in Preston had arguably limited the potential impact of Community Wealth Building in Preston. Despite this, appreciation for the approach and its aims remains strong. Community Wealth Building in Preston has led to economic gains that disproportionately benefited less advantaged groups, and this led to improvements in mental health and well-being. This seems to have been largely driven by changes in procurement practices of anchor institutions alongside policies to improve working conditions - such as the Living Wage. Future development should aim to shift the balance toward bottom-up civic engagement, which will help enhance sustainability of the approach. This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR130808. Economic differences between places lead to large differences in health, with poorer areas having poorer health. Community Wealth Building in Preston aimed to boost the economy for more disadvantaged groups by encouraging public sector and large charitable organisations to buy more services from local suppliers, help develop new charities and co-operatives and improve wages. By improving wages and reducing employment, which are important for good health, these changes could lead to improvements in health. We compared changes in mental health problems, well-being, wages, employment and the numbers of new charities established, in Preston, following this initiative, to changes in comparison areas with similar characteristics. We looked at contracts and invoices from local authorities across England to understand whether procurement practices were different in Preston compared to similar areas, whether this explained changes in the local economy and whether buying from local suppliers costs councils more than buying from further afield. We spoke to people from across Preston to understand what has helped or hindered these changes. Community Wealth Building in Preston led to a reduction in mental health problems, improved well-being, wages, employment and the establishment of new charities in Preston compared to the comparison areas. These improvements tended to be greatest in more disadvantaged groups. Preston City Council was more likely to buy services from local suppliers compared to other similar local authorities, and this practice is likely to have contributed to economic benefits. We found no evidence that procuring locally increased costs. People interviewed highlighted that the programme had initially focused on changes in how institutions spent their money, involvement of the public and community groups had been more limited. Community Wealth Building offers an effective strategy for promoting inclusive economic growth that improves mental health and well-being and reduces inequalities. Future development should aim for greater civic engagement.
Adolescents and young adults (AYAs) are frequently excluded from efforts to include patient research partners due to systemic and procedural barriers and lack of awareness by both researchers and patients. For meaningful collaboration to occur, patient partners must be prepared with appropriate knowledge, skills, and confidence. To co-design a model that trains AYAs with autoimmune conditions to be research partners and to evaluate feasibility for future application in other settings. Together with the Project Team, 12 AYAs with autoimmune conditions (16-22 years old) co-created the Young Patients' Autoimmune Research and Empowerment Alliance (YP AREA), a council aimed at elevating young patients' voices in research. AYA Council Members (CMs) completed two stages of training: (1) Educate (exposure to the research process) and (2) Empower (practice with advocating) and received 1-1 mentoring focused on individual goals. Two surveys (the Patient Engagement in Research Scale and the Research and Empowerment Survey) and qualitative interviews were conducted at the end of each stage to assess research readiness, empowerment, and perceptions of meaningful collaboration. After training activities, CMs reported personal growth and feeling like they were ready to partner with researchers. CMs highlighted the importance of community with like-minded peers. Survey scores showed that CMs felt highly engaged in the group process and had high levels of psychological empowerment and research readiness after trainings. Young patients can obtain high levels of engagement in the research process. This intentional training process was designed to meet AYAs at their developmental stage through individual mentoring, hands-on group activities, and community building. As a result, AYAs were empowered to advocate within research and academia for the healthcare needs of their communities. All Project Team Members and Council Members identify as patients with autoimmune conditions. Young patients co-designed all the activities included in this manuscript unless otherwise stated, co-conducted the evaluation, and co-authored this manuscript.
Engaging young people (10-24 years old) in research has been shown to improve the uptake and impact of HIV interventions in youth. However, how youth are engaged in Youth Advisory Boards (YABs) in low- and middle-income countries (LMICs) remains under-explored. Therefore, we conducted a scoping review and reflected on YAB members' experiences to examine YABs in youth HIV research. We conducted this study using a two-phase process. In phase one, we conducted a scoping review searching seven literature databases for peer-reviewed articles published in English between 2014 and 2024 that reported on YABs embedded within youth HIV research focused on people aged 10-24 years in LMICs. Data were synthesised to describe YAB composition, roles, and activities as well as the extent and timing of youth engagement. Phase two included integrating the lived experiences of co-authors, youth advocates and early-career researchers with prior YAB involvement, to supplement and contextualise the findings. Of 248 unique citations, 10 studies from five countries met the inclusion criteria. Most YABs (67%) included more than 10 members, and the majority (87%) consisted exclusively of youth. Membership age, where specified, ranged mostly 10-24 years old (80%). YAB activities included providing feedback on intervention design, community engagement, and implementation activities. Most studies reflected shared decision-making between youth and adults. However, youth involvement was typically limited to the 'Planning' and 'Conducting' phases of research. Youth engagement was not formally evaluated in any study. YABs are often used to support youth HIV research in LMICs, yet the nature and influence of their engagement remain under-evaluated. By integrating youth co-author reflections with published findings, this review highlights the need for more intentional, theory-informed, and sustained youth participation across all stages of research, as well as for the development and practical application of tailored evaluation frameworks.
This study explores a collaborative co-design process undertaken with people with lived experience expertise (PLEE), to develop a survey investigating experiences of social media and anxiety. The research is the first step in a larger project across five countries (Australia, the United Kingdom, India, Canada and Singapore) that will seek to validate whether passive smartphone analytics and codesigned ethical protocols can underpin a scalable culturally inclusive AI chatbot that detects and mitigates anxiety based on smartphone use. Through three iterative co-design workshops, conducted in Australia, facilitated by and involving people with lived experience of mental health conditions, insights were gathered on psychological, social, and structural mechanisms by which social-media use influences anxiety. Co-design workshop members strongly challenged the research team within five important themes: (1) reframing risk and safety that involved 'calling out' disempowering and discriminatory language inherent in survey processes and existing validated measures; (2) social media as both harm and Haven that emphasised social media as both a source of anxiety and a lifeline for connection for this population; (3) designing for inclusion, accessibility, and safety to ensure survey usability and psychological safety for future participants; (4) transparency, power, and representation to ensure lived experience involvement meant shared ownership, avoided tokenism, included First Nations leadership; and (5) broadening the lens - cultural, physical, and socio-economic factors involved urging a holistic view of the person and a systems view of anxiety and technology. By involving people with mental health lived experience expertise in the design process, this study was able to co-create recommendations to strengthen the project's survey design, ethical framework, and implementation plan. The co-design approach ensured the social media and anxiety survey met the specific needs of the target group and was trauma-informed, promoting trust, engagement and feasibility. Future research will aim to focus on gathering insights from similar lived experience co-design workshops in the United Kingdom, India, Canada and Singapore to refine the AI Chatbot prototype and evaluating its effectiveness in a broader study. This study underscores the crucial role of mental health lived experience expertise in research that seeks to test digital solutions for people who experience anxiety exacerbated by social media use. People with lived experience of a mental health condition contributed throughout the design, analysis and write-up of this work as members of a Lived Experience Advisory Panel (LEAP) which met over a series of co-design sessions. The co-design was led by a mental health lived experience researcher who was also a key member of the research team for the larger project. They led the reflexive thematic analysis, and writing and reviewing of the manuscript, in partnership with the co-design group members and the wider research team. Whilst some members of the academic research team identified as having mental health lived experience, they did not undertake their research roles from this perspective.
Registered dietitians (RDs) play a critical role in delivering family-centered care by engaging both fathers and mothers to support children's optimal long-term growth and development. Although fathers use distinct feeding practices and play an important role in shaping children's diet and growth, existing evidence suggests that they may be less engaged in pediatric nutrition care and services than mothers. Given that RDs are uniquely positioned to promote caregiver alignment in feeding practices and strengthen children's dietary and health outcomes, this study aimed to explore Canadian RDs' perceived confidence, facilitators, barriers, and resource needs related to father engagement in pediatric nutrition care and services. A cross-sectional online survey was distributed to RDs across Canada between November 2024 and July 2025. The survey included six 5-point Likert scale items assessing RDs' perceived confidence in engaging fathers in pediatric nutrition care and services, informed by the Connect, Attend, Participate, Enact (CAPE) model of parental engagement, as well as closed-ended questions on resource and training needs. Additionally, open-text questions assessed RDs' perceived facilitators and barriers to father engagement. Quantitative data were analyzed descriptively, while qualitative data were examined using an inductive content analysis approach to identify the major facilitator and barrier themes. A total of 129 RDs (96.9% female; 91.2% white; 69.0% ≥ 6 years of pediatric nutrition experience) participated in this study. While most RDs reported they felt very confident in inviting fathers to appointments (85.3%), encouraging their participation (83.7%), and contribution to care planning work (81.4%), fewer felt confident in retaining fathers in ongoing pediatric nutrition care and services (67.5%). Based on qualitative content analysis of open-text responses, the most commonly reported facilitators to father engagement included fathers' presence and availability (40.4%), interest and openness (35.1%), and high caregiving involvement (23.7%), while the most commonly reported barriers included fathers' absence at appointments (33.3%), limited caregiving roles (33.3%), fathers' limited availability due to work schedule (23.3%), and traditional gender norms undermining father engagement (16.7%). Only 3.1% RDs had received prior training in father-engagement practices. The top three selected resource needs were webinars (92.1%), websites with practice guidelines (66.7%), and self-assessment tools (44.4%). While RDs reported confidence in various aspects of father engagement, few had received formal training in this area. Study findings highlighted opportunities for targeted professional development resources within dietetics to enhance facilitators and address barriers to engaging fathers in pediatric nutrition care and services.
Practice-based research networks (PBRNs) rely on sustainable and interoperable IT infrastructures to support coordination, data management, and long-term collaboration across geographically distributed primary care practices. Large federated initiatives, such as the German DESAM-ForNet (Initiative of German Practice-Based Research Networks) program, face substantial sociotechnical challenges, as diverse user groups, heterogeneous local systems, and multiple governance levels must align around shared digital solutions. The aim of this study was to design and evaluate a participatory, consensus-driven process for developing a sustainable and interoperable IT solution that supports the coordination of multiple regional PBRNs, and to identify the sociotechnical factors that influence how such a process unfolds. A qualitative participatory multimethod design combined an iterative consensus-based IT development process in a central working group, interdisciplinary domain-driven design workshops (N=40 stakeholders from 6 PBRNs), and qualitative content analysis of internal documents (2020-2025). Members of the IT working group were nominated by networks based on IT responsibility and strategic involvement; workshop participants represented general practitioners, study nurses, researchers, and coordinators. Documents (meeting minutes, workshop artifacts, and decision logs) were coded inductively by 2 authors to trace sociotechnical dynamics and decision trajectories. The analysis revealed pronounced differences in IT ambitions, resources, and established practices across the 6 PBRNs (ranging from 2 to 90 person-months), which resulted in divergent expectations and uneven readiness for joint development. This heterogeneity-spanning objectives from simple REDCap (Research Electronic Data Capture; Vanderbilt University) databases to comprehensive digitization strategies-necessitated network-specific bounded contexts within a federated architecture. Through iterative development, stakeholders reached consensus on 6 core use cases (base data management, screening or recruitment processes, study or event participation tracking, management of event participation, accreditation procedures, and standardized communication or data exchange) and 2 national proofs-of-concept: quarterly key performance indicator reporting and pseudonymized practice queries based on a shared core dataset. This collaborative process culminated in a 3-tier practice relationship management infrastructure that integrates local autonomy with central metadata management and connectors to the Medical Informatics Initiative and REDCap, and was endorsed by the steering committee as a scalable compromise balancing interoperability and data sovereignty. The study shows that developing a national, interoperable IT infrastructure for PBRNs depends as much on social and organizational alignment as it does on technical solutions. Iterative participatory collaboration, transparent governance, and early stakeholder engagement were essential for building shared understanding and trust. Strengthening these relational and organizational elements will be crucial for sustaining future implementation efforts and fully realizing the potential of federated data infrastructures in primary care research.
Heterogeneity in outcome reporting and inconsistent use of outcome measurement instruments in allergy and clinical immunology research affects the comparability, synthesis, and clinical applicability of study findings. Harmonisation efforts, particularly Core Outcome Set (COS) development, aim to address these challenges by establishing standardised, evidence-based and consensus-driven outcome recommendations. This systematic review aims to map available COS and other harmonisation processes (HP) in allergy and clinical immunology, evaluate their methodological approaches, and assess their alignment with established development standards. We systematically searched MEDLINE, EMBASE, and the COMET Initiative database until June 7, 2024 to identify COS and HP. We included studies if they provided recommendations on 'core' outcomes and/or outcome measurement instruments. Data extraction included disease focus, methodological approach, stakeholder involvement, and adherence to the Core Outcome Set-STAndards for Development criteria. We synthesised the data at the initiative (process) level rather than the publication level because harmonisation initiatives are frequently iterative and reported across multiple papers (e.g., protocol, Delphi rounds, consensus statement, and subsequent instrument-selection outputs). A total of 15,612 records were identified, with 44 studies (representing 22 initiatives both finished and in development) meeting inclusion criteria. The majority of initiatives focused on asthma (n = 9), followed by eczema (atopic dermatitis n = 2; hand eczema = 1; eczema = 1), urticaria (n = 2), allergic rhinitis (n = 2), chronic rhinosinusitis (n = 1), celiac disease (n = 1), Immunoglobulin E (IgE)-mediated food allergy (n = 1), eosinophilic esophagitis (n = 1), and hereditary angioedema (n = 1). No COS or HP addressed drug allergy, anaphylaxis, or other immune-mediated allergic conditions. 'Quality of life' was consistently included in all COS with 'signs and symptoms', 'exacerbations' and 'disease control' frequently selected as well. Methodological approaches to COS development varied widely, with most employing Delphi surveys, consensus meetings, and stakeholder involvement, though levels of engagement differed. COS developers inconsistently adhered to Core Outcome Set-STAndards for Development criteria, with some initiatives demonstrating rigorous methodology while others lacked transparency in key developmental steps. This review highlights growing efforts to harmonise outcome assessment in allergy and clinical immunology. Major gaps remain in coverage and methodological rigour. Quality of life and patient-reported symptoms are frequently recommended outcomes, yet definitions and measurement tools are inconsistent. Strengthening methodological consistency and expanding COS development to neglected areas are critical next steps to improve outcome reliability and comparability in the field.
Digital health tools integrating electronic patient-reported outcome and experience measures (ePROMs/ePREMs) enable longitudinal monitoring of health-related quality of life (HRQoL), psychological well-being, and treatment satisfaction in pre-exposure prophylaxis (PrEP) users. However, determinants of sustained engagement with digital follow-up platforms remain insufficiently characterized. To describe the feasibility of the Naveta-Phemium digital platform for longitudinal monitoring of safety, HRQoL, and treatment satisfaction among PrEP users, and to develop and internally validate a machine learning framework to characterize and predict engagement with digital follow-up. A prospective observational study was conducted using the Naveta digital follow-up platform. HIV-negative adults at high risk of HIV infection received tenofovir disoproxil fumarate (245 mg) plus emtricitabine (200 mg). Clinical safety, HRQoL, and satisfaction were assessed using laboratory parameters and validated ePROMs/ePREMs (Hospital Anxiety and Depression Scale, Patient-Reported Outcome Measurement Information System Profile-29, Treatment Satisfaction Questionnaire for Medication, and Person-Centered Coordinated Care Experience Questionnaire). Engagement was defined at the questionnaire level and analyzed using the ALGOPROMIA-Classification framework with repeated stratified cross-validation. Model explainability was assessed using permutation-based Shapley Additive Explanations. A total of 81 participants contributed repeated questionnaire-level observations (mean PrEP duration 689 d). PrEP was well tolerated, with no moderate or severe adverse events; mild transient symptoms were mainly gastrointestinal (31/45, 68.9%) and neurological (26/45, 57.8%). Renal function remained stable (creatinine: 0.86 [SD 0.13] mg/dL; estimated glomerular filtration rate: P=.498). Psychological well-being and HRQoL remained stable (Hospital Anxiety and Depression Scale<7; Patient-Reported Outcome Measurement Information System Profile-29 near population norms). Treatment satisfaction was consistently high (Treatment Satisfaction Questionnaire for Medication≈85-87), and satisfaction with the NAVETA telemedicine model remained stable (8/10). Engagement showed clear sociodemographic and behavioral gradients. Ensemble-based machine learning models achieved good discrimination in predicting engagement (area under the curve≈0.82) across ≈12,300 questionnaire-level observations. Random forest was retained for robustness and consistency. Shapley Additive Explanations analysis highlighted lifestyle-related variables as the most influential predictors, with heterogeneous individual-level effects. Naveta enabled feasible telemedicine-based PrEP follow-up with preserved HRQoL, high satisfaction, and stable safety. Combining longitudinal ePROMs/ePREMs with explainable machine learning allowed detailed characterization of digital engagement, supporting digitally supported PrEP care optimization and informing future comparative and cost-effectiveness studies.