Ethics of DNA research on human remains: five globally applicable guidelines.

We are a group of archaeologists, anthropologists, curators and geneticists representing diverse global communities and 31 countries. All of us met in a virtual workshop dedicated to ethics in ancient DNA research held in November 2020. There was widespread agreement that globally applicable ethical guidelines are needed, but that recent recommendations grounded in discussion about research on human remains from North America are not always generalizable worldwide. Here we propose the following globally applicable guidelines, taking into consideration diverse contexts. These hold that: (1) researchers must ensure that all regulations were followed in the places where they work and from which the human remains derived; (2) researchers must prepare a detailed plan prior to beginning any study; (3) researchers must minimize damage to human remains; (4) researchers must ensure that data are made available following publication to allow critical re-examination of scientific findings; and (5) researchers must engage with other stakeholders from the beginning of a study and ensure respect and sensitivity to stakeholder perspectives. We commit to adhering to these guidelines and expect they will promote a high ethical standard in DNA research on human remains going forward.

Difficult climate-adaptive decisions in forests as complex social-ecological systems.

Climate change threatens the social, ecological, and economic benefits enjoyed by forest-dependent communities worldwide. Climate-adaptive forest management strategies such as genomics-based assisted migration (AM) may help protect many of these threatened benefits. However, such novel technological interventions in complex social-ecological systems will generate new risks, benefits, and uncertainties that interact with diverse forest values and preexisting risks. Using data from 16 focus groups in British Columbia, Canada, we show that different stakeholders (forestry professionals, environmental nongovernmental organizations, local government officials, and members of local business communities) emphasize different kinds of risks and uncertainties in judging the appropriateness of AM. We show the difficulty of climate-adaptive decisions in complex social-ecological systems in which both climate change and adaptation will have widespread and cascading impacts on diverse nonclimate values. Overarching judgments about AM as an adaptation strategy, which may appear simple when elicited in surveys or questionnaires, require that participants make complex trade-offs among multiple domains of uncertain and unknown risks. Overall, the highest-priority forest management objective for most stakeholders is the health and integrity of the forest ecosystem from which all other important forest values derive. The factor perceived as riskiest is our lack of knowledge of how forest ecosystems work, which hinders stakeholders in their assessment of AM's acceptability. These results are further evidence of the inherent risk in privileging natural science above other forms of knowledge at the science-policy interface. When decisions are framed as technical, the normative and ethical considerations that define our fundamental goals are made invisible.

Implementing Patient-Centered Outcomes Research Institute Stakeholder Engagement Principles in Models of Palliative Care Delivery and Advance Care Planning Research.

BACKGROUND: Given the many challenges of conducting research that addresses the palliative and end-of-life care needs of patients with serious illnesses, stakeholder engagement starting from the moment of study conceptualization and design is critical to ensure successful participant recruitment, data collection, intervention delivery, data analysis, and dissemination. METHODS: Guided by a conceptual model published by the Patient-Centered Outcomes Research Institute (PCORI) entitled, "Measuring What Matters for Advancing the Science and Practice of Engagement"14 and with the support of a PCORI Engagement Officer, representatives from 9 PCORI-funded study teams formed a working group to survey team members and review, outline, and describe key lessons learned and best practices for promoting stakeholder engagement in palliative care research. RESULTS: Almost all study teams engaged with patients/caregivers, clinicians, researchers, and health care system experts as stakeholder partners. About half the teams also included payers and training institutions as part of their stakeholder advisors as well as a range of content experts. Study teams relied on a variety of support structures and resources, and they employed 10 distinct methods for maintaining engagement. All engagement methods were generally considered to be effective by teams who used the method, though there was some variability in team-rated engagement quality of each method. Nine barriers to stakeholder engagement were identified across the 9 studies as well as 9 strategies (or facilitators) to overcome these barriers. We share examples of how stakeholder engagement impacted studies in all phases, including the preparatory phase, study initiation phase, execution phase, and data analysis/dissemination phase. CONCLUSIONS: Teams utilized a variety of resources and support structures as well as capitalized on multiple engagement methods for fostering stakeholder engagement, resulting in a high level of collaboration and integration.

A protocol for stakeholder engagement in head and neck cancer pragmatic trials.

Meaningful engagement with stakeholders in research demands intentional approaches. This paper describes the development of a framework to guide stakeholder engagement as research partners in a pragmatic trial proposed to evaluate behavioral interventions for dysphagia in head and neck cancer patients. We highlight the core principles of stakeholder engagement including representation of all perspectives, meaningful participation, respectful partnership with stakeholders, and accountability to stakeholders; and describe how these principles were operationalized to engage relevant stakeholders throughout the course of a large clinical trial.

Developing an intervention to support dietary change for shift workers living with type 2 diabetes: A stakeholder consultation.

BACKGROUND: Shift workers, compared to day workers, are more likely to be diagnosed with type 2 diabetes (T2D). Currently, there is no tailored programme of dietary support available to either shift workers living with T2D or employers. METHODS: An intervention development consultation workshop was convened in June 2023 with the aim of evaluating potential interventions to identify those with a potential to take forward for further development. Findings from prior formative research into factors influencing dietary behaviour in shift workers with T2D were mapped to potential interventions addressing the barriers and enablers to healthy eating reported by shift workers with T2D. The findings of the Shift-Diabetes Study were presented in the context of the COM-B (Capability, Opportunity, Motivation, Behaviour) theoretical framework of behaviour change. Three interventions in turn were presented to attendees: (1) Educational resources and structured education, (2) Increasing availability and accessibility of food on a night shift and (3) Biofeedback and tailored advice. Seven workshop attendees were invited to express their thoughts, using the APEASE criteria (Affordability, Practicability, Effectiveness, Acceptability, Side-effects/Safety, Equity) to guide the discussion. The workshop was conducted online and recorded, and transcripts were thematically coded to the APEASE framework. RESULTS/CONCLUSIONS: The workshop highlighted the importance of multilevel interventions to support dietary behaviour change in this occupational group. Priority actions identified include (i) understanding barriers to 24/7 food availability, (ii) including shift workers in clinical diabetes studies and (iii) research to understand the effectiveness of continuous glucose monitoring in shift workers with T2D.

A crowdsourcing open platform for literature curation in UniProt.

The UniProt knowledgebase is a public database for protein sequence and function, covering the tree of life and over 220 million protein entries. Now, the whole community can use a new crowdsourcing annotation system to help scale up UniProt curation and receive proper attribution for their biocuration work.

Implementation of post-discharge malaria chemoprevention (PDMC) in Benin, Kenya, Malawi, and Uganda: stakeholder engagement meeting report.

A Stakeholder engagement meeting on the implementation of post-discharge malaria chemoprevention (PDMC) in Benin, Kenya, Malawi, and Uganda was held in Nairobi, Kenya, on 27 September 2023. Representatives from the respective National Malaria Control Programmes, the World Health Organization (WHO) Geneva, Africa Regional and Kenya offices, research partners, non-governmental organizations, and the Medicines for Malaria Venture participated. PDMC was recommended by the WHO in June 2022 and involves provision of a full anti-malarial treatment course at regular intervals during the post-discharge period in children hospitalized with severe anaemia in areas of moderate-to-high malaria transmission. The WHO recommendation followed evidence from a meta-analysis of three clinical trials and from acceptability, delivery, cost-effectiveness, and modelling studies. The trials were conducted in The Gambia using monthly sulfadoxine-pyrimethamine during the transmission season, in Malawi using monthly artemether-lumefantrine, and in Kenya and Uganda using monthly dihydroartemisinin-piperaquine, showing a significant reduction in all-cause mortality by 77% (95% CI 30-98) and a 55% (95% CI 44-64) reduction in all-cause hospital readmissions 6 months post-discharge. The recommendation has not yet been implemented in sub-Saharan Africa. There is no established platform for PDMC delivery. The objectives of the meeting were for the participating countries to share country contexts, plans and experiences regarding the adoption and implementation of PDMC and to explore potential delivery platforms in each setting. The meeting served as the beginning of stakeholder engagement within the PDMC Saves Lives project and will be followed by formative and implementation research to evaluate alternative delivery strategies in selected countries. Meeting highlights included country consensus on use of dihydroartemisinin-piperaquine for PDMC and expansion of the target group to "severe anaemia or severe malaria", in addition to identifying country-specific options for PDMC delivery for evaluation in implementation research. Further exploration is needed on whether the age group should be extended to school-age children.

Multistakeholder Perceptions of Additional Value Elements for United States Value Assessment of Health Interventions.

OBJECTIVES: Limitations in conventional cost-effectiveness methods have led to calls for incorporation of additional value elements in assessments of health technologies. However, gaps remain in how additional value elements may inform decision making. This study aimed to prioritize additional value elements from the perspective of healthy individuals without a specific condition or indicated for a specific treatment in the United States among a multistakeholder panel and compare the importance of perspective-specific value elements. METHODS: Additional value elements were prioritized in 2 phases: (1) we identified and categorized additional value elements in a targeted literature review, and (2) we convened a multistakeholder group-based preference elicitation study (N = 28) to evaluate the description of each value element and rank and generate normalized weights of each value element for its significance in value assessment. The importance of additional value elements was also weighted relative to patient-centric value elements. RESULTS: The rank and weight of contextual value elements among 28 stakeholders were "severity of the disease" (26.2%), "disadvantaged and vulnerable target populations highly represented" (21.8%), "broader economic impact" (17.3%), "risk protection" (13.8%), "rarity of the disease" (11.3%), and "novel mechanism of action" (9.7%). Relative weight of the additional value elements versus patient-centric value elements was 52% and 48%, respectively. CONCLUSIONS: Study findings may inform priority setting for value frameworks and emerging US government assessments. The group-based elicitation method is repeatable and useful for structured deliberative processes in value assessment and may help improve the consistency and predictability of what is important to stakeholders.

Toward the Implementation of a Value Framework for Diagnostic Technologies: Operationalization, Piloting, and Validation in Latin America.

OBJECTIVES: In 2020, a group of 30 stakeholders from Latin America established 15 criteria for a diagnostic technologies value framework (D-VF) to help assess and inform decisions on diagnostic technologies. This article aims to present the operationalization, piloting, and initial validation of the framework for its implementation. METHODS: This work was carried out collaboratively with a variety of stakeholders. Three sequential phases were undertaken: (1) operationalization of the D-VF through a literature search for conceptual definitions and assessment tools, (2) piloting of the D-VF through a rapid health technology assessment document applying the methodology of the framework, and (3) a face validation process conducted through a virtual workshop, where usefulness and implementation aspects of the framework were assessed. RESULTS: The operationalization of the framework was conducted, and a methodological user guide was published. The D-VF criteria were applied in a health technology assessment document on human papilloma virus testing in cervical cancer screening. Also, an open-access training program was developed. Stakeholders agreed on the usefulness of the D-VF for assessment and decision-making stages of diagnostic technologies. However, they highlighted the need to improve technical capacities and the potential for added complexity when applying a D-VF with many criteria. The absence of an established value framework for diagnostic technologies in Latin America and the potential for strengthening technical capacities made the project valuable to those involved. CONCLUSIONS: The diagnostic technologies value framework was shown to be fit for implementation in real-life decision-making settings after the operationalization, piloting, and initial validation phases. Further experiences are important to support its implementation.

Editor's Choice - A Core Outcome Set for Intact Abdominal Aortic Aneurysm Repair.

OBJECTIVE: Technology and advances in clinical care have changed the management of abdominal aortic aneurysms (AAAs) but the clinical effectiveness of continuing advances needs to be assessed. To facilitate rapid synthesis of new evidence and improve stakeholder representation, including patients, the concept of core outcome sets (COS) has been developed. COS, reflecting the needs of all stakeholders, have been established across several surgical specialties. This study aimed to develop an international core outcome set for intact AAA repair. METHODS: Following COMET methodology, potential outcomes were identified from a systematic review of published outcomes and focus groups involving patients, carers, and nurses. A 38 question Delphi consensus survey in lay language was developed (with translation to local languages); this included 35 themes identified from the findings of the systematic review and three themes from the focus groups. All three of the themes identified by the focus groups (cognitive, physical, and social functioning) can be evaluated from quality of life instruments, with overall quality of life being identified from the systematic review. The survey was completed by patients, carers or family members, vascular nurses, vascular surgeons, trainees, interventional radiologists, anaesthetists, and industry partners from six European countries. After two rounds of the survey, the top outcomes were discussed at a face to face multistakeholder consensus meeting. RESULTS: The 38 item questionnaire was amended after piloting among all stakeholder groups. After the first round of the Delphi survey (98 respondents) 15 questions were eliminated, and 11 further questions were eliminated after round 2 (90 respondents). This left two outcome questions for discussion at the consensus meeting, where the top six outcomes were unanimously endorsed: death at 30 days (or in hospital if longer), secondary AAA rupture, overall quality of life and retention of cognitive functioning after recovery, five year survival, and continued sac growth. CONCLUSION: Six core outcomes are recommended for use as a minimum framework in all future studies and registries of intact open and endovascular AAA repair. Further work to select instruments for quality of life and to define instruments for cognitive functioning is needed.

"Nothing about us, without us": stakeholders perceptions on strategies to improve persons with disabilities' sexual and reproductive health outcomes in Ghana.

BACKGROUND: Persons with disabilities (PwDs) experience various adverse sexual and reproductive health (SRH) outcomes. However, there is a paucity of evidence on the strategies to improve their SRH outcomes. This study, therefore, used a pluralistic approach to explore PwDs and healthcare providers' (HPs) perspectives on how to improve the SRH of PwDs in Ghana. METHODS: In-depth interviews were conducted with 62 purposively selected stakeholders (37 PwDs and 25 HPs) in the Kumasi Metropolis and Offinso North District. The data was subjected to reflexive thematic analysis. RESULTS: Six major themes were generated from the data: Training for disability-sensitive and inclusive healthcare, Healthcare inclusivity - 'nothing about us, without us', Raising awareness for accessibility and equity, Impactful continuous monitoring and evaluation, Vital empowerment for self-reliance and Educating for disability-inclusive healthcare environment. These recommendations were synthesised to develop the THRIVE model-a comprehensive data driven framework from stakeholders that emphasises the importance of factors such as Training for disability-sensitive and inclusive healthcare, Healthcare inclusivity - 'nothing about us, without us', Raising awareness for accessibility and equity, Impactful continuous monitoring and evaluation, Vital empowerment for self-reliance and Enforcement of physical accessibility to improve their SRH outcomes. CONCLUSION: Using the evidence based THRIVE model could facilitate the development and strengthening of existing interventions and policies including the disability Act 715 to improve the SRH access and outcomes of PwDs in Ghana and other low-and middle-income countries.

Integration of a Tobacco Cessation Program into a Rural Community-Based Maternal and Child Health Program in India: A Stakeholders' Perspective on Task Shifting.

INTRODUCTION: According to the Global Adult Tobacco Survey-2, India, 7.5% of pregnant women are tobacco users with a high prevalence of smokeless tobacco use in rural India. Although pregnant women may receive advice to quit tobacco, lack of knowledge on providing cessation support among healthcare workers results in missed opportunities. Community Health Workers (CHWs) play a significant role in maternal and child health (MCH) programs. Thus, task-shifting for providing cessation support by CHWs was planned and the perceptions and attitudes of concerned stakeholders were explored. AIMS AND METHODS: A pre-implementation qualitative study was conducted in four states of India within existing rural, community-based MCH program settings. Implementation research frameworks were used to develop data collection tools and for inductive and deductive thematic analysis. In-depth interviews were conducted with stakeholders (n = 28) like coordinators, pregnant women, and village functionaries of the government health system. Four focus groups were conducted with female CHWs (n = 24). RESULTS: Stakeholders intended to adopt the intervention as objectives of the cessation intervention were aligned with the aims of the MCH program. CHWs related to their role in task-shifting and understood the context for implementing the intervention within the MCH program. Pregnant women expressed openness to receiving cessation support from CHWs acting as a facilitator for task-shifting. Barriers anticipated were the additional workload and time required for CHWs to implement the intervention. CONCLUSIONS: Task-shifting to female CHWs for screening tobacco users, providing brief advice and cessation support within the MCH program was perceived to be acceptable, adoptable, and feasible. IMPLICATIONS: The study builds insight into the process of developing a grounded approach for the integration of tobacco cessation intervention into a rural, community-based antenatal care setting by task shifting to female CHWs for providing cessation support to pregnant women. The study fills gaps in the literature related to establishing tobacco cessation interventions for pregnant women. The delineated efforts in integration of the intervention and task shifting can be replicated in other developing countries, especially in rural communities within South Asian and Southeast Asian regions having cultural practices, community-based healthcare structures, and tobacco consumption patterns that are comparable to India.

Perceived stakeholder benefits of continuously training general practitioners in the same rural or remote practice: interviews exploring the Remote Vocational Training Scheme.

OBJECTIVE: Explore stakeholder perspectives of the benefits of continuously training general practitioners in the same rural or remote practice in distributed locations via the Remote Vocational Training Scheme (RVTS). DESIGN, SETTING, PARTICIPANTS: Online one-hour semi-structured interviews were conducted with 27 RVTS staff, participants and supervisors from all states and territories between 16 October and 24 November 2023. Data were deductively and inductively coded by stakeholder type and the range of benefits, and the findings were informed by insights from a project reference group and a stakeholder advisory group. Questions explored the benefits of the RVTS - a program which supports doctors already working in rural, remote and First Nations communities to train towards general practice or rural generalist fellowship while remaining in the same practice. MAIN OUTCOMES MEASURES: Perspectives on the nature and spread of benefits. RESULTS: Broad benefits were perceived to flow to four system-level stakeholders: communities, health services, participants and policy makers. Perceived participant and community benefits were doctors staying longer in distributed locations with tailored place-based supports and training, doctors building relationships with patients, and doctors learning through longitudinal care. Health service benefits included reduced reliance on locums, improved continuity of accessible and appropriate services in areas otherwise facing major recruitment and retention issues, and the doctors having more time to contribute to improving service quality and upskilling local staff. Policy-maker benefits were sustaining safe and high quality services for distributed populations with high needs. CONCLUSION: The RVTS model was perceived to offer diverse benefits for different system stakeholders which could improve quality of learning, service delivery and community care. It also aligned with key policy directions for a distributed and sustainable generalist workforce under the goals of the National Medical Workforce Strategy 2021-2031 and the directions set by the independent review of overseas health practitioner regulatory settings led by Robyn Kruk. However, models like the RVTS largely rely on distribution levers to recruit more doctors to the locations it supports.

Pediatric Learning Health Networks in Solid Organ Transplantation-Engaging all Stakeholders to Achieve Health for Children Who Require Transplantation.

BACKGROUND: Learning Health Networks (LHN) have evolved within medicine over the past two decades, but their integration into transplantation has been more recent. OBJECTIVES AND METHODS: In this paper, we describe three LHNs in end-stage organ disease/transplantation, their common and unique features, and how their "actor-oriented" architecture allowed for rapid adaptation to meet the needs of their patients and practitioners during the recent COVID-19 pandemic. RESULT: The structure and focus of the Improving Renal Outcomes Collaborative (IROC), Starzl Network for Excellence in Pediatric Transplantation (SNEPT), and the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) are reviewed. We discuss the critical role of patient and family engagement, focusing on collaboration with Transplant Families. Finally, we review challenges common to the LHN concept and potential common areas of alignment to achieve the goal of more rapid and sustained progress to improve health in pediatric transplantation. CONCLUSION: LHN in transplantation are essential to accelerate knowledge dissemination and improve outcomes.

Successful implementation of a stakeholder engagement program for pharmacoepidemiologic research.

PURPOSE: Rigorously conducted pharmacoepidemiologic research requires methodologically complex study designs and analysis yet evaluates problems of high importance to patients and clinicians. Despite this, participation in and mechanisms for stakeholder engagement in pharmacoepidemiologic research are not well-described. Here, we describe our approach and lessons learned from engaging stakeholders, of varying familiarity with research methods, in a rigorous multi-year pharmacoepidemiologic research program evaluating the comparative effectiveness of diabetes medications. METHODS: We recruited 5 patient and 4 clinician stakeholders; each was compensated for their time. Stakeholders received initial formal training in observational research and pharmacoepidemiologic methods sufficient to enable contribution to the research project. After onboarding, stakeholder engagement meetings were held virtually, in the evening, 2-3 times annually. Each was approximately 90 min and focused on 1-2 specific questions about the project, with preparatory materials sent in advance. RESULTS: Stakeholder meeting attendance was high (89%-100%), and all stakeholders engaged with the research project, both during and between meetings. Stakeholders reported positive experiences with meetings, satisfaction, and interest in the research project and its findings, and dedication to the success of the project's goals. They affirmed the value of receiving materials to review in advance and the effectiveness of a virtual platform. Their contributions included prioritizing and suggesting research questions, optimizing written evidence briefs for a lay audience, and guidance on broader topics such as research audience and methods of dissemination. CONCLUSIONS: Stakeholder engagement in pharmacoepidemiologic research using complex study designs and analysis is feasible, acceptable, and positively impacts the research project.

Considerations across multiple stakeholder groups when implementing fall prevention programs in the acute hospital setting: a qualitative study.

BACKGROUND: Falls in hospital remain a common and costly patient safety issue internationally. There is evidence that falls in hospitals can be prevented by multifactorial programs and by education for patients and staff, but these are often not routinely or effectively implemented in practice. Perspectives of multiple key stakeholder groups could inform implementation of fall prevention strategies. METHODS: Clinicians of different disciplines, patients and their families were recruited from wards at two acute public hospitals. Semi-structured interviews and focus groups were conducted to gain a broad understanding of participants' perspectives about implementing fall prevention programs. Data were analysed using an inductive thematic approach. RESULTS: Data from 50 participants revealed three key themes across the stakeholder groups shaping implementation of acute hospital fall prevention programs: (i) 'Fall prevention is a priority, but whose?' where participants agreed falls in hospital should be addressed but did not necessarily see themselves as responsible for this; (ii) 'Disempowered stakeholders' where participants expressed feeling frustrated and powerless with fall prevention in acute hospital settings; and (iii) 'Shared responsibility may be a solution' where participants were optimistic about the positive impact of collective action on effectively implementing fall prevention strategies. CONCLUSION: Key stakeholder groups agree that hospital fall prevention is a priority, however, challenges related to role perception, competing priorities, workforce pressure and disempowerment mean fall prevention may often be neglected in practice. Improving shared responsibility for fall prevention implementation across disciplines, organisational levels and patients, family and staff may help overcome this.

Core outcome set for studies evaluating interventions to prevent or treat delirium in long-term care older residents: international key stakeholder informed consensus study.

BACKGROUND: Trials of interventions to prevent or treat delirium in older adults resident in long-term care settings (LTC) report heterogenous outcomes, hampering the identification of effective management strategies for this important condition. Our objective was to develop international consensus among key stakeholders for a core outcome set (COS) for future trials of interventions to prevent and/or treat delirium in this population. METHODS: We used a rigorous COS development process including qualitative interviews with family members and staff with experience of delirium in LTC; a modified two-round Delphi survey; and virtual consensus meetings using nominal group technique. The study was registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative (https://www.comet-initiative.org/studies/details/796). RESULTS: Item generation identified 22 delirium-specific outcomes and 32 other outcomes from 18 qualitative interviews. When combined with outcomes identified in our earlier systematic review, and following an item reduction step, this gave 43 outcomes that advanced to the formal consensus processes. These involved 169 participants from 12 countries, and included healthcare professionals (121, 72%), researchers (24, 14%), and family members/people with experience of delirium (24, 14%). Six outcomes were identified as essential to include in all trials of interventions for delirium in LTC, and were therefore included in the COS. These are: 'delirium occurrence'; 'delirium related distress'; 'delirium severity'; 'cognition including memory', 'admission to hospital' and 'mortality'. CONCLUSIONS: This COS, endorsed by the American Delirium Society and the European and Australasian Delirium Associations, is recommended for use in future clinical trials evaluating delirium prevention or treatment interventions for older adults residing in LTC.

"Research happens a lot in other settings-so why not here?" A qualitative interview study of stakeholders' views about advance planning for care home residents' research participation.

BACKGROUND: Underrepresentation of care home residents in research has resulted in a poorer evidence base for health care in care homes. Fewer opportunities to take part in research, as well as assumptions made by others about their interest or wishes, creates challenges for residents' inclusion in research. Early discussions about research preferences and wishes may be beneficial. This qualitative study aimed to explore stakeholders' views about how care home residents can be supported to communicate their wishes about research participation. METHOD: Semi-structured interviews were conducted with 25 stakeholders: care home residents (n = 5), relatives (n = 5), care home staff (n = 5), other health and social care professionals who work with care homes (n = 6), and care home researchers (n = 4). Interviews were conducted virtually or face-to-face and data were analysed using thematic analysis. RESULTS: Views about resident research participation, the barriers and facilitators to their inclusion, and the role of advance research planning were iteratively organized into three themes: (i) We're of no value to research; (ii) Research is difficult; and (iii) Advance research planning: good in theory, challenging in practice. Subthemes were also identified, and findings were discussed with a Patient and Public Involvement group for additional reflections. CONCLUSIONS: Stakeholders identified a number of barriers to including care home residents in research, including knowing their preferences about research. The development of interventions to facilitate communication that can be adapted to individuals' requirements are needed to support discussions and decision-making with care home residents about wishes and preferences for future research participation.