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As part of a five year plan (2019-2023), the Informed Health Choices Project, is developing and evaluating resources for helping secondary school students learn to think critically about health claims and choices. We will bring together key stakeholders; such as secondary school teachers and students, our main target for the IHC secondary school resources, school administrators, policy makers, curriculum development specialists and parents, to enable us gain insight about the context. To ensure that stakeholders are effectively and appropriately engaged in the design, evaluation and dissemination of the learning resources.To evaluate the extent to which stakeholders were successfully engaged. Using a multi-stage stratified sampling method, we will identify a representative sample of secondary schools with varied characteristics that might modify the effects of the learning resources such as, the school location (rural, semi-urban or urban), ownership (private, public) and ICT facilities (under resourced, highly resourced). A sample of schools will be randomly selected from the schools in each stratum. We will aim to recruit a diverse sample of students and secondary school teachers from those schools. Other stakeholders will be purposively selected to ensure a diverse range of experience and expertise. Together with the teacher and student networks and the advisory panels, we will establish measurable success criteria that reflect the objectives of engaging stakeholders at the start of the project and evaluate the extent to which those criteria were met at the end of the project. We aim for an increase in research uptake, improve quality and appropriateness of research results, accountability and social justice.

Background Obesity in adolescence has increased in the last decades. Adolescents fail to meet the recommended guidelines for physical activity (PA) and healthy diet. Adolescents with a low socioeconomic status (SES) particularly seem to have fewer healthy lifestyle behaviours. The European Science Engagement to Empower aDolescentS (SEEDS) project used an extreme citizen science approach to develop and implement healthy lifestyle behaviour interventions in high schools. As part of this project, key stakeholders were invited to reflect on the intentions of adolescents to engage in healthy lifestyle behaviours. The aim of this study was to gain stakeholder insights into the barriers and facilitators to healthy lifestyle behaviours of adolescents from low SES areas and on the possible role of these stakeholders in facilitating healthy lifestyle behaviours. Methods Six semi-structured focus groups were conducted in four European countries with 28 stakeholders from different settings (schools, community, and government), like teachers, policy advisors and youth workers. The theoretical framework of focus groups was based on the Theory of Planned Behaviour. The main questions of the focus groups were centred on PA and healthy diet. The focus groups were qualitatively analysed in NVivo using thematic analysis to identify topics and themes. Results According to stakeholders, adolescents have sufficient understanding of the importance of PA and a healthy diet, but nevertheless engage in unhealthy behaviour. Parents were mentioned as important facilitators for engaging adolescents in healthy lifestyle behaviours. Stakeholders listed lack of knowledge, time, and financial resources as barriers for adolescents from low SES families to engage in healthy lifestyle behaviours. The school environment was listed as an important facilitator of adolescents’ healthy lifestyle changes, but stakeholders acknowledged that current school days, curriculum and buildings are not designed to promote healthy lifestyle behaviours. External support and collaboration with community and governmental stakeholders was seen as potentially beneficial to improve healthy lifestyle behaviours. Conclusions This study shows the variety of barriers adolescents from low SES areas face, and the need for a broader collaboration between key stakeholders to facilitate healthy lifestyle behaviours. Schools are regarded specifically as important facilitators. Currently, the school environment entails various barriers. However, when addressing those, schools can increase opportunities for healthy lifestyle behaviours of adolescents from low SES areas. Trial registration This study is registered in ClinicalTrials.gov on 12/08/2021: NCT05002049.

Background Methods for developing a core outcome or information set require involvement of key stakeholders to prioritise many items and achieve agreement as to the core set. The Delphi technique requires participants to rate the importance of items in sequential questionnaires (or rounds) with feedback provided in each subsequent round such that participants are able to consider the views of others. This study examines the impact of receiving feedback from different stakeholder groups, on the subsequent rating of items and the level of agreement between stakeholders. Methods Randomized controlled trials were nested within the development of three core sets each including a Delphi process with two rounds of questionnaires, completed by patients and health professionals. Participants rated items from 1 (not essential) to 9 (absolutely essential). For round 2, participants were randomized to receive feedback from their peer stakeholder group only (peer) or both stakeholder groups separately (multiple). Decisions as to which items to retain following each round were determined by pre-specified criteria. Results Whilst type of feedback did not impact on the percentage of items for which a participant subsequently changed their rating, or the magnitude of change, it did impact on items retained at the end of round 2. Each core set contained discordant items retained by one feedback group but not the other (3–22 % discordant items). Consensus between patients and professionals in items to retain was greater amongst those receiving multiple group feedback in each core set (65–82 % agreement for peer-only feedback versus 74–94 % for multiple feedback). In addition, differences in round 2 scores were smaller between stakeholder groups receiving multiple feedback than between those receiving peer group feedback only. Variability in item scores across stakeholders was reduced following any feedback but this reduction was consistently greater amongst the multiple feedback group. Conclusions In the development of a core outcome or information set, providing feedback within Delphi questionnaires from all stakeholder groups separately may influence the final core set and improve consensus between the groups. Further work is needed to better understand how participants rate and re-rate items within a Delphi process. Trial registration The three randomized controlled trials reported here were each nested within the development of a core information or outcome set to investigate processes in core outcome and information set development. Outcomes were not health-related and therefore trial registration was not applicable.

Intervention trials promoting physical activity among older people frequently report low and unrepresentative recruitment. Better understanding of reasons for participation can help improve recruitment. This study explored why participants enrolled in the Coaching for Healthy Ageing (CHAnGE) trial, including how their decision was influenced by recruitment strategies. CHAnGE was a cluster randomised controlled trial testing the effectiveness of a healthy ageing program targeting inactivity and falls. Seventy-two groups of people aged 60+ were recruited from community organisations via informal presentations by the health coaches. We conducted a secondary thematic analysis of interview data from our wider qualitative evaluation in which 32 purposively sampled trial participants took part in semi-structured interviews about their experiences of CHAnGE. Data relating to recruitment and participation were analysed inductively to identify themes, then a coding framework comprising the core constructs from self-determination theory-autonomy, competence and relatedness-was used to explore if and how this theory fit with and helped to explain our data. Recruitment presentations promoted the CHAnGE intervention well in terms of addressing value expectations of structured support, different forms of accountability, credibility, achievability and, for some, a potential to enhance social relationships. Participation was motivated by the desire for improved health and decelerated ageing, altruism and curiosity. These factors related strongly to self-determination concepts of autonomy, competence and relatedness, but the intervention's demonstrated potential to support self-determination needs could be conveyed more effectively. Findings suggest that recruitment could have greater reach using: 1. Strengths-based messaging focusing on holistic gains, 2. Participant stories that highlight positive experiences, and 3. Peer support and information sharing to leverage altruism and curiosity. These theory-informed improvements will be used to increase participation in future trials, including people in hard-to-recruit groups. They may also inform other physical activity trials and community programs.

The Veterans Health Administration (VHA) has undertaken primary care transformation based on patient-centered medical home (PCMH) tenets. VHA PCMH models are designed for the predominantly male Veteran population, and require tailoring to meet women Veterans' needs. We used evidence-based quality improvement (EBQI), a stakeholder-driven implementation strategy, in a cluster randomized controlled trial across 12 sites (eight EBQI, four control) that are members of a Practice-Based Research Network. EBQI involves engaging multilevel, inter-professional leaders and staff as stakeholders in reviewing evidence and setting QI priorities. The goal of this analysis was to examine processes of engaging stakeholders in early implementation of EBQI to tailor VHA's medical home for women. Four inter-professional regional stakeholder planning meetings were conducted; these meetings engaged stakeholders by providing regional data about gender disparities in Veterans' care experiences. Subsequent to each meeting, qualitative interviews were conducted with 87 key stakeholders (leaders and staff). Stakeholders were asked to describe QI efforts and the use of data to change aspects of care, including women's health care. Interview transcripts were summarized and coded using a hybrid deductive/inductive analytic approach. The presentation of regional-level data about gender disparities resulted in heightened awareness and stakeholder buy-in and decision-making related to women's health-focused QI. Interviews revealed that stakeholders were familiar with QI, with regional and facility leaders aware of inter-disciplinary committees and efforts to foster organizational change, including PCMH transformation. These efforts did not typically focus on women's health, though some informal efforts had been undertaken. Barriers to engaging in QI included lack of communication across clinical service lines, fluidity in staffing, and lack of protected time. Inter-professional, multilevel stakeholders need to be engaged in implementation early, with data and discussion that convey the importance and relevance of a new initiative. Stakeholder perspectives on institutional norms (e.g., gender norms) and readiness for population-specific QI are useful drivers of clinical initiatives designed to transform care for clinical subpopulations.

Background Among food pantry users there is a high prevalence of both smoking and food insecurity, which may be related to one another. This study aims to evaluate the impact of a smoking cessation program carried out in food pantries on the smoking status and the food security status of food pantry users. Methods / design Before starting the cluster randomised controlled trial, stakeholders will be engaged to adapt a behavioural group counselling program for smoking cessation to the needs of the food pantry users in a pre study. Food pantry users and workers as well as other experts, such as smoking cessation trainers, social workers, and psychologists, will be involved, using the world café technique and telephone interviews and a qualitative thematic analysis for data analysis to design the concept of the intervention program will be applied. In the second phase, the impact of the intervention on the smoking status and on food insecurity will be investigated by a cluster randomised controlled trial. A total of 416 food pantry users across 32 clusters (food pantries) in Berlin, Germany, should be recruited and randomly assigned to either the intervention group or the waiting list control group. The intervention will consist of a behavioural group counselling program for smoking cessation, specially tailored for food pantry users, as well as optional nicotine replacement therapy and the implementation of environmental smoking reduction measures in the food pantries. The primary outcomes 6 months after the treatment will be self-reported continuous smoking abstinence, validated by exhaled carbon monoxide (< 10 ppm of carbon monoxide), and increased food security level (the percentage of participants with an improved food security level). Discussion This study will be the first long-term investigation into the effect of a smoking cessation program on smoking status and food insecurity. The results of this study will inform the implementation of smoking cessation programs in food pantries throughout Germany. Trial registration Prospectively registered DRKS00020037 . Registered 29 April 2020

Background One important ethical issue in randomised controlled trials (RCTs) is randomisation. Relatively little is known about how participating individuals and communities understand and perceive central aspects of randomisation such as equality, fairness, transparency and accountability in community-based trials. The aim of this study was to understand and explore study communities’ perspectives of the randomisation process in a cluster RCT in rural Zambia studying the effectiveness of different support packages for adolescent girls on early childbearing. Methods In this explorative study, in-depth semi-structured interviews were carried out in 2018 with 14 individuals who took part in the randomisation process of the Research Initiative to Support the Empowerment of Girls (RISE) project in 2016 and two traditional leaders. Two of the districts where the trial is implemented were purposively selected. Interviews were audio recorded and fully transcribed. Data were analysed by coding and describing emergent themes. Results The understanding of the randomisation process varied. Some respondents understood that randomisation was conducted for research purposes, but most of them did not. They had trouble distinguishing research and aid. Generally, respondents perceived the randomisation process as transparent and fair. However, people thought that there should not have been a “lottery” because they wanted all schools to receive equal or balanced benefits of the interventions. Conclusions Randomisation was misunderstood by most respondents. Perceived procedural fairness was easier to realize than substantive fairness. Researchers working on Cluster Randomised Controlled Trials (CRCTs) should consider carefully how to explain randomisation.

Background Sharing interim data, results or result extrapolations is an important issue that can affect trial integrity. The different ways in which Data Safety Monitoring Boards (DSMBs) share interim results with non-DSMB members and the acceptability of such practices are poorly understood. Our objective was to undertake a narrative review specifically on what kind of interim results, if any, should be shared by the DSMB with non-DSMB members and why. Methods We conducted a narrative review using a systematic search strategy of several databases and major health research stakeholders. Literature was included if there was some discussion within the full text about sharing interim trial results with non-DSMB members. Results About 79.6% (129/162) of included citations were based on author’s views, 16.7% (27/162) on research guidelines and 3.7% (6/162) on surveys. The largest group of citations, 73/162 (45%), expresses the opinion or argument against sharing interim results with exceptions. Trailing closely, 71/162 (43.8%) of the included citations support the opinion or argument that interim results should not be shared and should remain confidential with the DSMB. Half of the six surveys support sharing in some capacity, while the other three do not. Eleven circumstances were found that potentially warrant interim result sharing by the DSMB; they relate to (1) usual practices by DSMBs, (2) trial completion threatened, (3) patient safety, (4) regulatory approval and (5) other circumstances. Dominant risks for sharing under these conditions are associated with introducing trial bias. Discussion/conclusion There was no majority view in the literature. However, the largest group of citations included express the idea that interim results should remain confidential with the DSMB but also acknowledge circumstances when they could be shared with non-DSMB members. Limitations of this review are that (1) the included literature predominately provides personal perspectives, not evidence, and (2) surveys found globally focus on trial monitoring practices lacking detailed information on what specifically to share, with whom and why. More research is needed with the use of a detailed survey of the clinical trial community focused on DSMB sharing interim results, to better understand and guide DSMB interim result sharing practices.

Background Despite growing recognition of the importance of identifying unmet needs in palliative care, there remains no clear, operational definition of what constitutes unmet palliative care needs. This gap hinders service planning, policy development and equitable access to care. We aimed to explore priorities for understanding and measuring unmet palliative care needs with stakeholders, including people with lived and professional experience. Methods Three online workshops using a modified nominal group technique with people with lived experience of life-limiting illness (as patients or informal carers) and professionals in palliative care. Separate workshops were held for each group to independently identify elements that capture the concept of unmet palliative care needs, followed by a combined workshop to refine and consolidate findings. Workshop data (scribe notes) were analysed using content analysis. Participants then completed an online ranking exercise to prioritise key elements, which was analysed descriptively. Results Twenty-eight individuals participated, including 11 people with lived experience (two patients and nine informal carers) and 17 with professional experience. In the final workshop, participants agreed on a list of 27 elements capturing unmet palliative care needs, which were conceptualised in two main ways: (1) service-related (e.g. lack of a single point of contact to access support, including out-of-hours), and (2) those related to symptoms and concerns, (e.g. pain not assessed and managed). Twenty-three participants completed the ranking exercise. Highly prioritised elements included lack of timely and holistic assessment of symptoms or suffering, inability to access services needed, lack of coordination, and continuity of care. Other priorities for understanding and measuring unmet palliative care needs were lack of timely follow-up to address symptoms, lack of skilled support, and lack of respect, dignity and empathy. Conclusions This study is the first to engage both individuals with lived experience and professionals in conceptualising unmet palliative care needs. Stakeholders prioritised two broad aspects important for capturing unmet palliative care needs: symptom-related concerns and service-related issues. These findings provide a foundation for developing stakeholder-informed tools to assess unmet palliative care needs that are feasible for use across diverse care settings and populations.

Background Patient and public involvement (PPI) has become essential in health research. However, little is known about multiple stakeholders' perspectives on the implementation of PPI in community mental health research settings. The present study aimed to qualitatively analyse multiple stakeholders' views on PPI, including potential concerns, barriers and approaches. Methods This study involved conducting focus group interviews and collecting qualitative data from 37 participants in multiple stakeholder groups (patients = 6, caregivers = 5, service providers = 7, government staff = 5 and researchers = 14) in the community mental health field. The data were qualitatively analysed using a data‐driven approach that derived domains, themes and subthemes related to perspectives on PPI and to specific challenges and approaches for implementing PPI. Results The qualitative analysis identified four domains. The ‘Positive views and expectations regarding PPI’ domain consisted of themes related to supportive views of PPI in a mental health service research setting and improvements in the quality of research and service. The ‘General concerns about PPI’ domain included themes concerning the need for non‐PPI research and tokenism, excessive expectations concerning social changes and use of evidence from PPI research, and heavy burdens resulting from PPI. The ‘Specific issues regarding the implementation of PPI’ domain consisted of four themes, including academic systems, selection methods (e.g., representativeness and conflict of interest issues), relationship building, and ambiguous PPI criteria. In particular, all stakeholder groups expressed concerns about relational equality during PPI implementation in Japan. The ‘Approaches to PPI implementation’ domain included themes such as facilitating mutual understanding, creating a tolerant atmosphere, establishing PPI support systems (e.g., training, ethics and human resource matching) and empowering patient organizations. Conclusion The study replicated most of the barriers and approaches to PPI reported by qualitative research in Western counties. However, utilization of evidence produced by PPI research and partnership in the PPI process may be particularly serious issues in Japan. Future PPI studies should carefully address solutions that fit each culture. Patient or Public Contribution A patient‐researcher was involved in all stages of this project, from development of the research topic and the protocol to manuscript preparation.