Health Research Research Articles

Innovation in the Production of Coffee Tree Leaf Beverages

Objective: The objective of this study was to process coffee leaves to obtain a product with greater added value. Theoretical Framework: In this study, the processing of coffee leaves was like the processing of yerba mate to produce chimarrão. The enzyme inactivation technique is applied prior to drying, the leaves are exposed to a flame for a short period. The yellowish-green color is more uniform among the group of inactivated leaves and indicates good efficiency at this stage. Method: The coffee leaves were divided into two groups for enzymatic inactivation in times of 60 seconds and 120 seconds. The leaves were dehydrated at a temperature of 60ºC for four hours. After drying, the material was ground, and colorimetric analysis was carried out (12 tasters participated in the sensory analysis). Results and Discussion: Statistical analysis demonstrated that there was no significant difference in the preference of the product served, with or without sugar. The importance of an integrated approach in the processing of coffee leaves is highlighted, considering the physical-chemical, sensorial aspects and including pharmacological effects beneficial to health Research Implications: The growing human search for a more balanced and healthy diet promotes the addition of functional and medicinal beverages to diet, creating a challenge. Originality/Value: The importance of an integrated approach in the processing of coffee leaves is highlighted, considering the physical-chemical, sensorial aspects and including pharmacological effects beneficial to health.

Research priorities for preterm lung health research across the lifespan: a community priority setting partnership

BackgroundIt is essential to embed patient and public perspectives into every stage of the research journey, including setting the future research agenda. The substantial gaps in our understanding of prematurity-associated...

Human research ethics committee processes and practices for approving Aboriginal and Torres Strait Islander health research: a mixed methods study.

To describe human research ethics committee (HREC) members' reports of: HREC membership structures; HREC processes for reviewing Aboriginal and Torres Strait Islander health and medical research; and experiences and perceptions of review operations. Cross-sectional 36-item survey and qualitative interviews with a subsample of survey participants. Current and past members (preceding five years) of HRECs who assessed Aboriginal and Torres Strait Islander research. Survey and interview results related to HREC structures, processes and functioning; challenges in review processes; and what is needed to improve ethical governance. 229 HREC members completed the survey and 13 were interviewed. Half the participants (115 of 221, 52%) reported having an Aboriginal and Torres Strait Islander representative position. Key issues identified related to assessment processes and resourcing, including burden on Aboriginal and Torres Strait Islander members, ability for Aboriginal and Torres Strait Islander HRECs to manage additional applications, lack of clarity around specific assessment criteria for general population studies, lack of cohesion across the application or complaints processes, and lack of resourcing and infrastructure to monitor ethical practice after approval. Aboriginal and Torres Strait Islander people carry an important role and burden in the review of applications and monitoring of health research. However, Aboriginal and Torres Strait Islander people are not presently involved in all aspects of ethical research governance within current HREC structures, including the review and monitoring of approved research. Standardised processes and guidelines that uphold Aboriginal and Torres Strait Islander rights and expert knowledges are required.

Aboriginal and Torres Strait Islander community experiences and recommendations for health and medical research: a mixed methods study.

To describe Aboriginal and Torres Strait Islander communities' processes, positioning and experiences of health and medical research and their recommendations. A cross-sectional online and paper-based survey. Representatives from Aboriginal and Torres Strait Islander health services and community-controlled organisations in Australia. Responses to a 33-item mixed methods survey that explored communities' positioning and processes relating to health and medical research and their experiences of health and medical research in the previous 5 years. Recommendations for improving health and medical research were elicited via two open-ended questions. Fifty-one community representatives nationally responded to the survey. Most representatives reported feeling slightly or very positive about research (37, 73%). More than half (33, 65%) reported having formal governance processes, and two-thirds of those without governance processes were interested in establishing such processes (12, 67%). Almost half reported that research has sometimes or never had benefit (25, 49%). Ethical principles that were most often reported as essential included those relating to sharing results back with community (45, 88%), translating research into policy and practice (37, 73%), employing Aboriginal and Torres Strait Islander staff (37, 73%), Indigenous data sovereignty and governance (36, 71%) and research agreements (35, 69%). Community representatives reported being approached frequently and in the later stages of research, with little input during the development and design stages of research. Most representatives reported that their communities had participated in Indigenous-led research (39, 76%). Community representatives highlighted the need for appropriate resourcing and funding to drive and lead their own research agendas. Aboriginal and Torres Strait Islander communities continue to have negative experiences of research despite four decades of advocating for control, ownership and leadership of health and medical research. Researchers, funding bodies and institutions must examine current funding and research structures that reinforce current practices, to ensure transparency and accountability to communities by repositioning and giving power to communities to direct and lead their own health and medical research agendas.

Beyond ethical guidelines: upholding Aboriginal and Torres Strait Islander ethical governance in health and medical research. A scoping review.

To examine what ethics approvals are being sought for Aboriginal and Torres Strait Islander health and medical research, and to determine what proportion of this research upholds Aboriginal and Torres Strait Islander ethical governance via an Aboriginal and Torres Strait Islander community-controlled human research ethics committee (AHREC) by jurisdiction and funding body type. Scoping review of all original, peer-reviewed health and medical literature published over a 5-year period (January 2018 to December 2022). Extending on a previous review, the search tool LIt.search was used to access all literature relating to Aboriginal and Torres Strait Islander health and medical research. 589 eligible publications were included from the parent review, and a further 1703 publications were identified from the updated search. A total of 945 publications were included. A substantial number of ethics approvals were obtained from government-based ethics committees (394, 41.7%). More than half of the publications reported obtaining institutional ethics approval (514, 54.4%). Less than half (400, 42.3%) reported obtaining AHREC approval. Almost one-third of publications were on research that was conducted in states or territories where there is no AHREC (334, 35.3%). Publications did not always report obtaining AHREC approvals, including in jurisdictions where one operates. We found a concerning lack of Aboriginal and Torres Strait Islander ethical governance reported in health and medical research. Acknowledging that Aboriginal and Torres Strait Islander ethics guidelines and AHRECs were established due to harm caused to communities, these results suggest a high risk, with research not consistently being deemed safe, respectful and beneficial with appropriate AHREC ethics review and approval. We join calls for the establishment of AHRECs in all jurisdictions and nationally. Furthermore, we urge funding bodies and institutions to uphold requirements for Aboriginal and Torres Strait Islander ethical governance in research and funding agreements, as well as institutional policies and procedures.

Researchers' self-reported adherence to ethical principles in Aboriginal and Torres Strait Islander health and medical research and views on improving conduct: a mixed methods study.

To examine researchers' reports of adherence to ethical principles in their most recent research project, including factors associated with higher self-reported adherence, and perceptions of how research conduct could be improved. Online cross-sectional survey. Researchers who had conducted any health or medical research that included Aboriginal and Torres Strait Islander people or their data. Researchers rated their adherence to 15 ethical principles extracted from ethical guidelines in their most recent research project on a 5-point Likert scale (poor to excellent), and reported what they believe is needed to improve the conduct of Aboriginal and Torres Strait Islander health and medical research. 391 researchers completed the survey. Those with > 10 years' experience in the field were significantly more likely to self-report adhering to all 15 key ethical principles compared with those with ≤ 5 years' experience. Compared with those with ≤ 5 years' experience, those with 6-10 years' experience were significantly more likely to self-report adhering to: engaging community in identifying research priorities (odds ratio [OR], 2.05; [95% confidence interval (CI), 1.23-3.40]); engaging community in developing the research questions (OR, 2.16; 95% CI, 1.32-3.55); and engaging community in research implementation (OR, 2.10; 95% CI, 1.25-3.54). Aboriginal and Torres Strait Islander participants were significantly more likely to self-report adhering to the following principles than non-Indigenous participants: engaging community in identifying research priorities (OR, 1.90; 95% CI, 1.16-3.10); engaging community in developing the research questions (OR, 2.16; 95% CI, 1.30-3.61); engaging community in research implementation (OR, 1.92; 95% CI, 1.14-3.20); embedding Aboriginal governance, advisory and decision making on the project (OR, 2.10; 95% CI, 1.26-3.50); embedding opportunities in the research for capacity building for communities (OR, 1.70; 95% CI, 1.04-2.77); and enacting Indigenous data sovereignty and governance principles (OR, 1.67; 95% CI, 1.02-2.70). Open-ended responses indicated research conduct could be improved by recognition of community as experts, genuine partnerships and engagement, and pathways for Aboriginal and Torres Strait Islander researchers and support to strengthen the field. Structural and individual change is required to accommodate community priority setting, governance, consultation, leadership and translation in the conduct of ethical Aboriginal and Torres Strait Islander health and medical research. Such changes should be flexible and responsive to calls made by Aboriginal and Torres Strait Islander researchers and communities.

Reported processes and practices of researchers applying for human research ethics approval for Aboriginal and Torres Strait Islander health research: a mixed methods study.

To examine self-reported practices for obtaining ethics approval and reflections on ethics application processes among researchers who have conducted Aboriginal and Torres Strait Islander health and medical research. Cross-sectional online survey. Australian-based researchers who conducted research that included Aboriginal and Torres Strait Islander people or their data. Results from a 74-item online survey that participants completed, which included questions on demographics, ethics processes, perceptions of engagement in Aboriginal and Torres Strait Islander research, and barriers to and enablers of conducting Aboriginal and Torres Strait Islander research. Of 553 eligible researchers who commenced the survey, 439 (79.4%) answered all of the questions and were included in the analysis. A total of 327 participants (74.5%) had obtained ethics approval from an Aboriginal human research ethics committee (AHREC), 254 (57.9%) had obtained multistate ethics approvals and 270 (61.5%) had not participated in ethics training specifically for Aboriginal and Torres Strait Islander research. Participants were significantly more likely to report being very or extremely confident in managing the ethics application process if they had ≥ 6 years of research experience, had participated in training, had obtained ethics approval from an AHREC, or dedicated > 50% of their time to Aboriginal and Torres Strait Islander research. Participants acknowledged the importance of ethics approval processes in improving research practices, however they identified time and costs as barriers. Aboriginal and Torres Strait Islander participants identified that ethics processes do not always uphold Indigenous approaches or methodologies. Processes for obtaining ethics approval for Aboriginal and Torres Strait Islander health and medical research do not meet contemporary research needs and would be strengthened by streamlining ethics application processes, reducing time and cost barriers, and enhancing cultural appropriateness. We join calls for the establishment of state-based AHRECs in every jurisdiction, and a national Aboriginal and Torres Strait Islander human research ethics committee to review cross-jurisdictional research.

How well are researchers applying ethical principles and practices in Aboriginal and Torres Strait Islander health and medical research? A cross-sectional study.

Describe perceptions of how well researchers conducting Aboriginal and Torres Strait Islander health and medical research apply ethical research practices. Cross-sectional online survey. Researchers who included Aboriginal and Torres Strait Islander people or their data in their projects, and current or past members (previous 5 years) of a human research ethics committee that assessed Aboriginal and Torres Strait Islander research. Researchers' engagement with 15 ethical research practices (on a 5-point Likert scale, poor to excellent). 561 participants (382 researchers [68.1%] and 179 human research ethics committee members [31.9%]) completed the survey. Across all research practices, a rating of excellent was least frequently endorsed, with the highest frequency being for employing Aboriginal and Torres Strait Islander team members (38 participants [6.8%]). A rating of poor was most common for enacting Indigenous data sovereignty and governance principles (156 participants [27.8%]). Aboriginal and Torres Strait Islander respondents had significantly lower odds of perceiving high levels of adherence to ethical principles than non-Aboriginal and Torres Strait Islander respondents for all ethical principles, except employing Aboriginal and Torres Strait Islander team members. In particular, Aboriginal and Torres Strait Islander participants had 65% lower odds of perceiving that researchers have high rates of adhering to disseminating results back to the community (odds ratio [OR], 0.35; 95% CI, 0.22-0.57), 56% lower odds of perceiving that researchers have high rates of adhering to engaging Aboriginal community in research implementation (OR, 0.44; 95% CI, 0.27-0.73), and 54% lower odds of perceiving that researchers have high rates of adhering to engaging Aboriginal community in developing research questions (OR, 0.46; 95% CI, 0.28-0.75). Researchers are not consistently implementing all ethical practices outlined in guidelines for research involving Aboriginal and Torres Strait Islander people. We call for commitment from researchers, institutions and funding bodies to address shortfalls, embed processes, and hold researchers accountable to Aboriginal and Torres Strait Islander people, communities and the principles and guidelines they have established.

Effective dietary interventions during pregnancy: a systematic review and meta-analysis of behavior change techniques to promote healthy eating

Improving dietary intake during pregnancy can mitigate adverse consequences for women and their children. The effective techniques and features for supporting and sustaining dietary change during pregnancy and postpartum are minimally reported. The primary aims of this systematic review and meta-analysis were to summarise the effectiveness of dietary interventions for pregnant woman, identify which behaviour change techniques (BCTs) and intervention features were most frequently used and determine which were most effective at improving dietary intake. Six databases were searched to identify randomised control trials (RCTs) reporting on dietary intake in pregnant women over the age of sixteen, with an active intervention group compared to a control group receiving usual care or less intensive interventions. The Cochrane Risk of Bias Tool 1 was used to assess study validity. BCTs were coded by two authors using Michie et al.’s BCT taxonomy V1. A random effect model assessed intervention effects on indices of dietary quality and food groups (fruit, vegetables, grains and cereals, meat, and dairy) in relation to the use of BCTs and intervention features. Thirty- seven RCTs met the inclusion criteria. High heterogeneity was observed across intervention characteristics and measures of fidelity. Only half of the available BCTs were used, with eleven used once. The BCT category Reward and threat was successful in improving dietary quality and vegetable intake, whilst 'Action planning’ (1.4) from the category Goals and planning significantly improved dietary quality. Interventions delivered by a nutrition professional and those that included group sessions improved dietary quality more than those delivered by other health professionals, research staff, or application-delivered interventions and delivered via other modalities. Future dietary interventions during pregnancy should incorporate and report on BCTs used in the intervention. Successful design elements for improving antenatal dietary intake may include multimodal interventions delivered by nutrition professionals and the use of Rewards and Goal setting.

Serotonin attenuates tumor necrosis factor-induced intestinal inflammation by interacting with human mucosal tissue.

The intestine hosts the largest immune system and peripheral nervous system in the human body. The gut‒brain axis orchestrates communication between the central and enteric nervous systems, playing a pivotal role in regulating overall body function and intestinal homeostasis. Here, using a human three-dimensional in vitro culture model, we investigated the effects of serotonin, a neuromodulator produced in the gut, on immune cell and intestinal tissue interactions. Serotonin attenuated the tumor necrosis factor-induced proinflammatory response, mostly by affecting the expression of chemokines. Serotonin affected the phenotype and distribution of tissue-migrating monocytes, without direct contact with the cells, by remodeling the intestinal tissue. Collectively, our results show that serotonin plays a crucial role in communication among gut-brain axis components and regulates monocyte migration and plasticity, thereby contributing to gut homeostasis and the progression of inflammation. In vivo studies focused on the role of neuromodulators in gut inflammation have shown controversial results, highlighting the importance of human experimental models. Moreover, our results emphasize the importance of human health research in human cell-based models and suggest that the serotonin signaling pathway is a new therapeutic target for inflammatory bowel disease.

Suicidality in Autistic Adolescents and Adults: Sleep the Unexplored Connection?

Despite substantial evidence linking insomnia with increased suicidality in non-autistic populations, its role in autism remains under-explored. Poor sleep, most commonly insomnia symptoms (hereafter insomnia), is a significant issue in autism, affecting up to 80% of autistic children and adults, compared with 30%-50% of children and about 45% of adults in the general population. Sleep, along with quality of life, anxiety, depression, and social well-being, is a top mental health research priority for autistic adults. These factors are all significantly associated with insomnia in both autistic and non-autistic individuals. Current findings highlight the association between depression, psychosocial factors, and suicidality in autistic individuals. Key factors in suicidality for autistic people include increased autistic traits, loneliness, lack of social support, and experiences such as camouflaging and burnout. What is under-explored is the role of sleep in suicidality and mental health in autism. Effective psychological interventions for insomnia in autistic individuals are lacking, and there is limited understanding of whether treating insomnia can reduce suicidality. Only two pilot studies have investigated insomnia treatments for autistic adults. In this commentary, we argue that, given the high rate of suicidality in autism and the potential role of insomnia, it is crucial to investigate whether insomnia contributes to suicidality in autistic people and if addressing sleep through prevention strategies, supports, and interventions improves outcomes. Collaboration with the autistic community is essential for addressing this knowledge gap and developing effective interventions.

Why the South African National Health Research Ethics Council is wrong about ownership of human biological material and data.

The South African National Health Research Ethics Council (NHREC) states in its 2024 Ethics Guidelines that human biological material (HBM) and data cannot be privately owned under South African law. This position conflicts with established legal principles, guidelines by the Health Professions Council of South Africa (HPCSA), and South African university policies, all of which support private ownership of HBM and data. Private ownership is not only legally sound but also ethically necessary, providing a framework for accountability, ensuring fair recognition of institutional contributions, and enabling responsible custodianship over these valuable resources. The NHREC's denial of private ownership of HBM and data undermines South African research institutions' ability to control their research assets and leaves them vulnerable to exploitation by foreign entities. The NHREC should issue a corrigendum to delete its incorrect position on private ownership of HBM and data.

South-North Learning in Mapuche Territory- Report back from the 10th Escuela Abierta de Salud Pública in Temuco, Araucania, Chile

This article summarizes the proceedings of the 10th Escuela Abierta de Salud Pública (Public Health Open School), held in the Mapuche territory, Temuco, Araucania, Chile in the spring of 2024. The free school brought together more than one hundred Indigenous and community leaders and organizers, students, clinicians, academics, educators, workers, and organizers to build collective analysis and action about health under capitalism. The conference focused on the emancipatory praxis of social determination of health and critical interculturality, which put forward transformative, meta-critical agendas for public and collective health research and practice. The article is submitted as a contribution to the growing and necessary movement for genuine South-North learning and collaboration to build a public and collective health praxis that is up to the challenge of intervening in the deepening crises of the global capitalist order.

Process Evaluation of a Rapid Evidence Support System Assessment of Ireland’s Department of Health – A Protocol

Background The Rapid Evidence Support System Assessment (RESSA) was developed by the Global Evidence Commission to evaluate evidence support systems that inform policy decisions. These systems are designed to contextualize existing evidence, guide decision-making, and generate new insights to inform action. As evidence-informed policymaking gains traction globally, it is essential to evaluate these systems’ effectiveness. In Ireland, the Health Research Board, the Department of Health, Evidence Synthesis Ireland, Cochrane Ireland, and the Global Evidence Commission are collaborating to conduct a RESSA within the Department of Health. This process evaluation aims to assess the fidelity, acceptability, and experiences of stakeholders involved in the RESSA, providing insights for refining the methodology. Methods The process evaluation will employ a mixed methods approach, integrating both qualitative and quantitative data collection. It will evaluate the conduct of a RESSA within the Department of Health. Fidelity assessment will examine adherence to the RESSA protocol, while acceptability will be evaluated using the Theoretical Framework of Acceptability, focusing on key stakeholders' attitudes. An exploration of the experiences of participants, capturing both facilitators and barriers to the RESSA’s success will also be conducted. Data analysis will involve thematic analysis and descriptive statistics, aiming to highlight the RESSA’s methodological strengths and areas for improvement. Conclusions This evaluation is expected to provide critical insights into the strengths and limitations of the RESSA methodology, with implications for evidence-informed policymaking. Findings will offer recommendations to enhance the robustness and applicability of the RESSA in Ireland and beyond. Dissemination will include academic publications and reports, contributing to the broader understanding of effective evidence support systems. This process evaluation aims to inform future RESSAs and strengthen the evidence support framework, ensuring better-informed policy decisions at local, national, and international levels.

Opening the black box of health systems performance management using the behaviour change techniques taxonomy: implications for health research and practice

BackgroundPerformance management (PM) systems in healthcare consist of many interacting interventions, such as contracts, scorecards and incentives. The diversity, complexity and poor description of PM interventions hampers replication in research, standardized comparative analysis and accumulation of evidence. Specifying PM systems and interventions in terms of their behaviour change techniques (BCTs) using standardized language can address these challenges and clarify the mechanisms linking system-level PM with individual behaviours.MethodsWe conducted an analysis of BCTs in a PM system in Ontario, Canada using a modified behaviour change technique taxonomy (BCTT). We reviewed 64 documents, observed 15 meetings and conducted 4 semi-structured interviews with key informants to map the PM interventions on to the taxonomy.ResultsWe identified 54 BCTs spanning 13 taxonomy domains in the PM system. BCTs were concentrated in four domains: (1) goals and planning, (2) reward and threat, (3) feedback and monitoring and (4) identity. The BCTs coded most often included: (1) discrepancy between current behaviour and goal, (2) feedback on outcome(s) of behaviour, (3) social comparison and (4) social incentive/reward. These BCTs suggest that this PM system seeks to change behaviour primarily by directing programme attention to their current performance in relation to the target and in relation to other programs across the province, and by acknowledging good performance with praise or recognition. A total of five PM interventions accounted for 58% of identified BCTs – the scorecard, quarterly performance review reports, quarterly performance review meetings, escalation letter for poor or declining performance and the improvement action plan.ConclusionsThe results provide a unique analytical and evaluative characterization of the PM system, revealing how a behaviour-change lens on health systems PM can support the (re)design, standardized comparison, and evaluation of PM systems in research and in practice.

Canada’s First National Oral Health Research Strategy (2024–2030)

Recent years have seen significant positive changes and developments in oral health–related policy and data on oral health and oral health care in Canada. Simultaneously, on the international stage, the momentum for oral health and related research continues to build. These changes have led to an initiative to create Canada’s first National Oral Health Research Strategy (NOHRS), which was recently published by the Canadian Institutes of Health Research–Institute of Musculoskeletal Health and Arthritis (Allison and Rock 2024). In this communication, we describe the process that was used to undertake this work. We present the resulting guiding principles, the research priority areas, and the framework that emerged, which included 6 strategic priorities grouped into 3 themes: (A) Leading Issues: (1) access to care, (2) inequities, identities, and oral health; (B) Emerging Methods: (3) artificial intelligence, (4) omics; and (C) Overarching Approaches: (5) environmental sustainability, (6) knowledge mobilization and implementation science. In addition, NOHRS includes a series of proposed goals and a timeline over the coming years. The point is to encourage a broad range of individuals and groups of people to engage with this high-level strategy and create plans to implement it. This strategy directly answers the call by the World Health Organization for countries to establish a national oral health research strategy (World Health Organization 2024). We have engaged in an extensive, broad consultative process, resulting in a Canadian NOHRS that is tailored to the needs of our community. Its aim is to galvanize our community into action to address the priorities we have identified. By engaging in this process, we build upon multiple oral health–related initiatives in Canada and on the international stage. We hope to inspire and facilitate similar, much-needed work elsewhere.

Rapid Review of Literature Reporting the Experience of Patient and Public Involvement in Prison and Forensic Mental Health Research.

Health research authorities around the world are increasingly committed to embedding public involvement in health and social care research. However, such involvement in internationally published prison and forensic mental health research remains rare. It is therefore particularly important to understand how people are experiencing collaborative research in this field, barriers they may encounter and how these might be overcome. The aim of this review is to explore how academic, practitioner and lived-experience researchers have experienced collaborating on prison and forensic mental health research since a previous review of the topic in 2016. A rapid review of literature was completed by searching three databases (MEDLINE, EMBASE and PsycINFO) between 2016 and July 2023 in addition to Google and Google Scholar searches and hand searching the reference lists of all screened-in documents. We used Reflexive Thematic Analysis to review the screened-in papers. We had lived-experience involvement in this study, which is outlined in our Supporting Information. The database search returned 733 unique articles. Internet searches revealed 10 potentially relevant documents. 20 documents were eligible for inclusion; 15 journal articles, three book chapters, a whole book and a PhD thesis. In the analysis, four overarching themes were developed: the positive psychological impact on lived-experience researchers; it is interpersonally, emotionally and practically challenging; facilitators of the collaborative research process; and positive impact of involvement on the research. Our findings build on the previous review by providing evidence that collaborating on research can have a positive psychological impact on people with lived experience in this setting. It also documents further challenges that are unique to the forensic setting. There was minimal reporting of the experiences of forensic mental health patients involved in research; most included documents focused the experiences of current or former prisoners. Further studies in the topic area are still needed, which utilise a research method to analyse the experiences of conducting collaborative research.

Best Practices Guidelines for the Engagement of People With Lived Experience and Family Members in Mental Health and Substance Use Health Research: A Modified Delphi Consensus Study.

People with lived experience of mental health and/or substance use conditions and their families (PWLE) are increasingly engaged in research, yet rigorous guidelines for engagement are lacking. This study aims to co-design best practice guidelines to support the authentic, meaningful engagement of PWLE in mental health and/or substance use health research. A multi-panel modified Delphi study was conducted with 61 expert panelists (35 PWLE and family members, 26 researchers/research support staff from across Canada). Participants rated 56 recommendations for importance and clarity. Consensus was defined as ≥ 70% of participants rating items at6 or 7 on a 7-point Likert scale ('very important' or 'essential'). Qualitative feedback was analysed using content analysis to identify new items and reviewed for improvements in item clarity. After each round, items not meeting the established threshold of importance were removed. Items with low clarity scores were reworded. A PWLE advisory panel was actively involved throughout the study's design, implementation, interpretation, and reporting, ensuring that the perspectives of people with lived experience were integrated throughout the research process. Three Delphi Rounds were conducted. In Round 1, importance ratings ranged from 51.7% to 96.7% of participants ranking the items above the established threshold (average 80.1%), with clarity ratings ranging from 39.3% to 86.9% (average 70.7%) and an average importance coefficient of variation (CV) of 0.16. Four items were deleted, two new items were added and fifty-five items were revised. In Round 2, 60 (98.4%) participants responded. Importance ratings ranged from 57.6% to 96.7% (average 80.2%; average CV = 0.20). Clarity ratings ranged from 50.9% to 93.2% (average 77.9%). Five items were deleted and eleven revised. In Round 3, 60 (98.4%) participants provided importance ratings ranging from 66.7% to 98.3% (average 80.8%; average CV = 0.20), and clarity ratings ranging from 63.3% to 94.9% (average 81.1%). Three items were deleted and nine were revised. Forty-four final best practices are proposed. These co-developed best practice guidelines offer recommendations for meaningful PWLE engagement in mental health and/or substance use health research. By following these guidelines, research teams can ensure that PWLE contributions are genuinely valued and effectively integrated, ultimately enhancing the quality and impact of the research and fostering authentic collaboration. People with lived experience were engaged throughout the project as key team members, from a patient-oriented research perspective. They are also co-authors on this manuscript.

Evaluating Process and Outcomes of Public Involvement in Applied Health and Social Care Research: A Rapid Systematic Review.

Public Involvement (PI) in applied health and social care research has grown exponentially in the UK. This review aims to synthesise published UK evidence that evaluates the process and/or outcome(s) of PI in applied health and social care research to identify key contextual factors, effective strategies, outcomes and public partner experiences underpinning meaningful PI in research. Following a pre-registered protocol, we systematically searched four databases and two key journals for studies conducted within the UK between January 2006 and July 2024. A team of public partners and researchers carried out independent dual screening and data extraction. Included studies were narratively synthesised via Framework Synthesis. Nineteen studies evaluated the PI process with a range of populations including National Health Service (NHS) users, carers, and low-income communities. No specific outcome evaluations were identified. Through their experience, public partners described important components of meaningful PI such as mutual respect and seeing and contributing to change, as well as some unintended harms of involvement. Harms related to 'experiencing negative attitudes', 'emotional burden of involvement', 'frustration and disappointment' and 'further marginalisation'. Meaningful PI was underpinned by structural, organisational, interpersonal and individual factors; as well as practical and principle-based strategies of involvement. Both public partners and researchers reflected on a range of outcomes of meaningful PI including changes to the research process and longer term impacts on organisations, researchers and public partners. PI in research must be facilitated at multiple levels to reduce unintended harm and encourage meaningful and impactful outcomes. Findings are summarised within a model which gives an overview of priorities for individual researchers, organisations and funders to ensure best practice is achievable. From a methodological perspective, researchers should prioritise robust, transparent and co-produced approaches to evaluating PI to increase knowledge in the field. A regional public advisory network provided insight on the relevance and acceptability of the review concept. Our core research team included three public partners. Public partners contributed to the development of the initial review protocol, abstract and full-text screening, reviewing findings and their interpretation and writing the final report.

Ethical issues in conducting health research with people in prison: Results of a deliberative research project conducted with people in Australian prisons.

Planning research involving people in prison raises concerns based on past abuses of incarcerated people amongst other factors. Despite the development of guidelines for the ethical conduct of research in prisons, researchers and advocates have questioned whether current approaches aimed at protecting incarcerated persons from unethical research unfairly exclude this group from participating in and benefitting from research. Discussion of these issues comes mostly from expert opinion. An absent voice is that of people in prison. This study identifies the key ethical issues according to people in prison for health research involving people in prison. Using a deliberative approach, citizens' juries were conducted in six Australian prisons (three men's and three women's) between January and May 2019. A total of fifty participants were selected following an expression of interest process. Pre-recorded information by experts was shown to participants who subsequently deliberated for almost 4h before collectively agreeing on key ethical issues. Reoccurring issues selected were: 1. Participants receive study results; 2. Involve individuals with lived experience in assessing what research should happen in prison; 3. Ensure access to research opportunities is equal to those in the community; 4. Address recruitment bias by preventing custodial staff selection of participants; 5. Protect the confidentiality of participant responses; 6. Recognize the capacity of people in prison to give informed consent; and 7. Prevent conflicts of interest that could result in research findings censorship by prison authorities. Focal points within identified issues are described and suggest that if we are to genuinely consider the voices of people in prison, then it may be time to incorporate ways for research participation to be more accessible to incarcerated citizens.