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Background: Acne is common, can cause significant impact on quality of life and is a frequent reason for long-term antibiotic use. Spironolactone has been prescribed for acne in women for many years, but robust evidence is lacking., Objective: To evaluate whether spironolactone is clinically effective and cost-effective in treating acne in women., Design: Pragmatic, parallel, double-blind, randomised superiority trial., Setting: Primary and secondary healthcare and community settings (community and social media advertising)., Participants: Women aged 18 years and older with facial acne persisting for at least 6 months, judged to potentially warrant oral antibiotic treatment., Interventions: Participants were randomised 1 : 1, using an independent web-based procedure, to either 50 mg/day spironolactone or matched placebo until week 6, increasing to 100 mg/day spironolactone or matched placebo until week 24. Participants continued usual topical treatment., Main Outcome Measures: Primary outcome was the adjusted mean difference in Acne-Specific Quality of Life symptom subscale score at 12 weeks. Secondary outcomes included Acne-Specific Quality of Life total and subscales; participant self-assessed improvement; Investigator's Global Assessment; Participant's Global Assessment; satisfaction; adverse effects and cost-effectiveness., Results: Of 1267 women assessed for eligibility, 410 were randomised (201 intervention, 209 control), 342 in the primary analysis (176 intervention, 166 control). Mean age was 29.2 years (standard deviation 7.2) and 7.9% (28/356) were from non-white backgrounds. At baseline, Investigator's Global Assessment classified acne as mild in 46%, moderate in 40% and severe in 13%. At baseline, 82.9% were using topical treatments. Over 95% of participants in both groups tolerated the treatment and increased their dose. Mean baseline Acne-Specific Quality of Life symptom subscale was 13.0 (standard deviation 4.7) across both groups. Mean scores at week 12 were 19.2 (standard deviation 6.1) for spironolactone and 17.8 (standard deviation 5.6) for placebo [difference favouring spironolactone 1.27 (95% confidence interval 0.07 to 2.46) adjusting for baseline variables]. Mean scores at week 24 were 21.2 (standard deviation 5.9) in spironolactone group and 17.4 (standard deviation 5.8) in placebo group [adjusted difference 3.77 (95% confidence interval 2.50 to 5.03) adjusted]. Secondary outcomes also favoured spironolactone at 12 weeks with greater differences at 24 weeks. Participants taking spironolactone were more likely than those taking placebo to report overall acne improvement at 12 weeks {72.2% vs. 67.9% [adjusted odds ratio 1.16 (95% confidence interval 0.70 to 1.91)]} and at 24 weeks {81.9% vs. 63.3% [adjusted odds ratio 2.72 (95% confidence interval 1.50 to 4.93)]}. Investigator's Global Assessment was judged successful at week 12 for 31/201 (18.5%) taking spironolactone and 9/209 (5.6%) taking placebo [adjusted odds ratio 5.18 (95% confidence interval 2.18 to 12.28)]. Satisfaction with treatment improved in 70.6% of participants taking spironolactone compared with 43.1% taking placebo [adjusted odds ratio 3.12 (95% confidence interval 1.80 to 5.41)]. Adverse reactions were similar between groups, but headaches were reported more commonly on spironolactone (20.4% vs. 12.0%). No serious adverse reactions were reported. Taking account for missing data through multiple imputation gave an incremental cost per quality-adjusted life-year of £27,879 (adjusted) compared to placebo or £2683 per quality-adjusted life-year compared to oral antibiotics., Conclusions: Spironolactone resulted in better participant-reported and investigator-reported outcomes than placebo, with greater differences at week 24 than week 12., Trial Registration: This trial is registered as ISRCTN12892056 and EudraCT (2018-003630-33)., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/13/02) and is published in full in Health Technology Assessment ; Vol. 28, No. 56. See the NIHR Funding and Awards website for further award information.

Background: Care home residents often lack access to end-of-life care from specialist palliative care providers. Palliative Care Needs Rounds, developed and tested in Australia, is a novel approach to addressing this., Objective: To co-design and implement a scalable UK model of Needs Rounds., Design: A pragmatic implementation study using the integrated Promoting Action on Research Implementation in Health Services framework., Setting: Implementation was conducted in six case study sites (England, n = 4, and Scotland, n = 2) encompassing specialist palliative care service working with three to six care homes each., Participants: Phase 1: interviews ( n = 28 care home staff, specialist palliative care staff, relatives, primary care, acute care and allied health practitioners) and four workshops ( n = 43 care home staff, clinicians and managers from specialist palliative care teams and patient and public involvement and engagement representatives). Phase 2: interviews ( n = 58 care home and specialist palliative care staff); family questionnaire ( n = 13 relatives); staff questionnaire ( n = 171 care home staff); quality of death/dying questionnaire ( n = 81); patient and public involvement and engagement evaluation interviews ( n = 11); fidelity assessment ( n = 14 Needs Rounds recordings)., Interventions: (1) Monthly hour-long discussions of residents' physical, psychosocial and spiritual needs, alongside case-based learning, (2) clinical work and (3) relative/multidisciplinary team meetings., Main Outcome Measures: A programme theory describing what works for whom under what circumstances with UK Needs Rounds. Secondary outcomes focus on health service use and cost effectiveness, quality of death and dying, care home staff confidence and capability, and the use of patient and public involvement and engagement., Data Sources: Semistructured interviews and workshops with key stakeholders from the six sites; capability of adopting a palliative approach, quality of death and dying index, and Canadian Health Care Evaluation Project Lite questionnaires; recordings of Needs Rounds; care home data on resident demographics/health service use; assessments and interventions triggered by Needs Rounds; semistructured interviews with academic and patient and public involvement and engagement members., Results: The programme theory: while care home staff experience workforce challenges such as high turnover, variable skills and confidence, Needs Rounds can provide care home and specialist palliative care staff the opportunity to collaborate during a protected time, to plan for residents' last months of life. Needs Rounds build care home staff confidence and can strengthen relationships and trust, while harnessing services' complementary expertise. Needs Rounds strengthen understandings of dying, symptom management, advance/anticipatory care planning and communication. This can improve resident care, enabling residents to be cared for and die in their preferred place, and may benefit relatives by increasing their confidence in care quality., Limitations: COVID-19 restricted intervention and data collection. Due to an insufficient sample size, it was not possible to conduct a cost-benefit analysis of Needs Rounds or calculate the treatment effect or family perceptions of care., Conclusions: Our work suggests that Needs Rounds can improve the quality of life and death for care home residents, by enhancing staff skills and confidence, including symptom management, communications with general practitioners and relatives, and strengthen relationships between care home and specialist palliative care staff., Future Work: Conduct analysis of costs-benefits and treatment effects. Engagement with commissioners and policy-makers could examine integration of Needs Rounds into care homes and primary care across the UK to ensure equitable access to specialist care., Study Registration: This study is registered as ISRCTN15863801., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR128799) and is published in full in Health and Social Care Delivery Research ; Vol. 12, No. 19. See the NIHR Funding and Awards website for further award information.

Patient and public involvement and engagement (PPIE) is an increasingly important component of research conduct to enhance processes and potential for impact, yet is rarely critically interrogated. This paper draws on Foucauldian analysis to highlight the disciplinary powers and tensions arising in PPIE. The paper draws on a nested evaluation interview study with three PPIE members and eight academics, who had been involved in an implementation science study focused on palliative care. PPIE members were involved in the whole study and are co-authors of this article. Through shared values and commitments to the study, a team culture of equality was developed. Yet while power was dispersed and taken-up by all team members, in so doing a self-governance approach within the team was developed. The pace and focus of discussions was at times more subjugating than co-production. Identities and positions were porous; the simplistic division of 'academic' and 'PPIE' did not stand up to scrutiny, with an increasing blurring of boundaries as people's experiences and insights changed over time. Continual, subtle, negotiations of roles, inputs and identities were manifest throughout the project. PPIE in research involves subtle, complex and ongoing disciplinary practices enacted by all members of the team., (© 2024 The Authors. Sociology of Health & Illness published by John Wiley & Sons Ltd on behalf of Foundation for the Sociology of Health & Illness.)

Background: Citizen science is a way to democratise science by involving groups of citizens in the research process. Clinical guidelines are used to improve practice, but their implementation can be limited. Involving patients and the public can enhance guideline implementation, but there is uncertainty about the best approaches to achieve this. Citizen science is a potential way to involve patients and the public in improving clinical guideline implementation. We aimed to explore the application of citizen science methods to involve patients and the public in the dissemination and implementation of clinical guidelines in oral health and dentistry., Methods: We developed GUIDE (GUideline Implementation in oral health and DEntistry), a citizen science online platform, using a participatory approach with researchers, oral health professionals, guideline developers and citizens. Recruitment was conducted exclusively online. The platform focused on prespecified challenges related to oral health assessment guidelines, and asked citizens to generate ideas, as well as vote and comment on other citizens' ideas to improve those challenges. Citizens also shared their views via surveys and two online synchronous group meetings. Data were collected on participant's demographics, platform engagement and experience of taking part. The most promising idea category was identified by an advisory group based on engagement, feasibility and relevance. We presented quantitative data using descriptive statistics and analysed qualitative data using inductive and deductive thematic analysis., Results: The platform was open for 6 months and we recruited 189 citizens, from which over 90 citizens actively engaged with the platform. Most citizens were over 34 years (64%), female (58%) and had a university degree (50%). They generated 128 ideas, 146 comments and 248 votes. The challenge that led to most engagement was related to prevention and oral health self-care. To take this challenge forward, citizens generated a further 36 ideas to improve a pre-existing National Health Service oral care prevention leaflet. Citizens discussed motivations to take part in the platform (understanding, values, self-care), reasons to stay engaged (communication and feedback, outputs and impact, and relevance of topics discussed) and suggestions to improve future platforms., Conclusion: Citizen science is an effective approach to generate and prioritise ideas from a group of citizens to improve oral health and dental services. Prevention and oral health self-care were of particular interest to citizens. More research is needed to ensure recruitment of a diverse group of citizens and to improve retention in citizen science projects., Patient or Public Contribution: This project was inherently conducted with the input of public partners (citizen scientists) in all key aspects of its conduct and interpretation. In addition, two public partners were part of the research team and contributed to the design of the project, as well as key decisions related to its conduct, analysis, interpretation and dissemination and are co-authors of this manuscript., (© 2023 The Authors. Health Expectations published by John Wiley & Sons Ltd.)

Background: Patient and public involvement (PPI) in trials aims to enhance research by improving its relevance and transparency. Planning for statistical analysis begins at the design stage of a trial within the protocol and is refined and detailed in a Statistical Analysis Plan (SAP). While PPI is common in design and protocol development it is less common within SAPs. This study aimed to reach consensus on the most important and relevant statistical analysis items within an SAP to involve patients and the public., Methods: We developed a UK-based, two-round Delphi survey through an iterative consultation with public partners, statisticians, and trialists. The consultation process started with 55 items from international guidance for statistical analysis plans. We aimed to recruit at least 20 participants per key stakeholder group for inclusion in the final analysis of the Delphi survey. Participants were asked to vote on each item using a Likert scale from 1 to 9, where a rating of 1 to 3 was labelled as having 'limited importance'; 4 to 6 as 'important but not critical' and 7 to 9 as 'critical' to involve patients and the public. Results from the second round determined consensus on critical items for PPI., Results: The consultation exercise led to the inclusion of 15 statistical items in the Delphi survey. We recruited 179 participants, of whom 72% (129: 36 statisticians, 29 patients or public partners, 25 clinical researchers or methodologists, 27 trial managers, and 12 PPI coordinators) completed both rounds. Participants were on average 48 years old, 60% were female, 84% were White, 64% were based in England and 84% had at least five years' experience in trials. Four items reached consensus regarding critical importance for patient and public involvement: presentation of results to trial participants; summary and presentation of harms; interpretation and presentation of findings in an academic setting; factors impacting how well a treatment works. No consensus was reached for the remaining 11 items. In general, the results were consistent across stakeholder groups., Discussion: We identified four critical items to involve patients and the public in statistical analysis plans. The remaining 11 items did not reach consensus and need to be considered in a case-by-case basis with most responders considering patient and public involvement important (but not critical). Our research provides a platform to enable focused future efforts to improve patient and public involvement in trials and enhance the relevance of statistical analyses to patients and the public., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Goulão et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: This study aims to estimate the cost-effectiveness of oral spironolactone plus routine topical treatment compared with routine topical treatment alone for persistent acne in adult women from a British NHS perspective over 24 weeks., Design: Economic evaluation undertaken alongside a pragmatic, parallel, double-blind, randomised trial., Setting: Primary and secondary healthcare, community and social media advertising., Participants: Women ≥18 years with persistent facial acne judged to warrant oral antibiotic treatment., Interventions: Participants were randomised 1:1 to 50 mg/day spironolactone (increasing to 100 mg/day after 6 weeks) or matched placebo until week 24. Participants in both groups could continue topical treatment., Main Outcome Measures: Cost-utility analysis assessed incremental cost per quality-adjusted life year (QALY) using the EQ-5D-5L. Cost-effectiveness analysis estimated incremental cost per unit change on the Acne-QoL symptom subscale. Adjusted analysis included randomisation stratification variables (centre, baseline severity (investigator's global assessment, IGA <3 vs ≥3)) and baseline variables (Acne-QoL symptom subscale score, resource use costs, EQ-5D score and use of topical treatments)., Results: Spironolactone did not appear cost-effective in the complete case analysis (n=126 spironolactone, n=109 control), compared with no active systemic treatment (adjusted incremental cost per QALY £67 191; unadjusted £34 770). Incremental cost per QALY was £27 879 (adjusted), just below the upper National Institute for Health and Care Excellence's threshold value of £30 000, where multiple imputation took account of missing data. Incremental cost per QALY for other sensitivity analyses varied around the base-case, highlighting the degree of uncertainty. The adjusted incremental cost per point change on the Acne-QoL symptom subscale for spironolactone compared with no active systemic treatment was £38.21 (complete case analysis)., Conclusions: The results demonstrate a high level of uncertainty, particularly with respect to estimates of incremental QALYs. Compared with no active systemic treatment, spironolactone was estimated to be marginally cost-effective where multiple imputation was performed but was not cost-effective in complete case analysis., Trial Registration Number: ISRCTN registry (ISRCTN12892056)., Competing Interests: Competing interests: We declare no support from any organisation other than the NIHR for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work; no other relationships or activities that could appear to have influenced the submitted work. LH has received consultancy fees from the University of Oxford on an educational grant funded by Pfizer, unrelated to the submitted work. THS was a member of NIHR HTA Efficient Study Designs-2, HTA Efficient Study Designs Board, HTA End of Life Care and Add-on-Studies, HTA Primary Care Themed Call Board and the HTA Commissioning Board between 2013 to December 2019. She is a steering committee member of the UK Dermatology Clinical Trials Network and Chair of the NIHR Research for Patient Benefit Regional Advisory Panel for the East of England. THS had no part in the decision-making for funding this study., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Background: The use of decentralised clinical trials (which bring trials to patients through remote processes and technology versus central on-site visits) has been thought to be a potential solution to common recruitment and retention barriers. However, there is a lack of evidence to understand the experiences, needs and preferences of the public to inform trial methodologies that appeal to different populations. We report participant experiences of SAFA, a partially decentralised randomised clinical trial, to inform the methodology used in future dermatology trials that aim to appeal to women aged 18 and over., Methods: Participants of the SAFA (Spironolactone for Adult Female Acne) trial were invited to take part in a qualitative semi-structured interview to explore their experience and perspectives of taking part in the trial. Questions focused on their experience of using decentralised methods to access and enrol in the trial (e.g. social media advertising), in addition to the decentralised trial visit and data collection methods used throughout. Interviews were conducted remotely, recorded, and transcribed. Data were analysed using reflexive thematic analysis., Results: Twelve SAFA participants (all women, age range 22-36 years) were interviewed. Initially, participants were influenced to enrol by trusted online information, the feeling of validation the trial provided, and the convenience and flexibility offered by the decentralised methods and research staff made participants feel valued and enabled them to engage in the trial with minimal interference to existing commitments. SAFA participants were generally accepting of trial demands, such as the text-heavy paperwork and on-site visits for blood collection and highlighted several areas relevant for trial conduct going forwards including where decentralised methods may (and may not) be accepted and how trial accessibility and understanding could be improved., Conclusions: The study has shown that decentralised methods used by responsive and approachable staff were widely accepted in the SAFA trial. Interviewees found the methods adopted in the SAFA trial helped the trial to fit with their needs and promoted a sense of feeling valued that encouraged ongoing trial engagement. Decentralised methods should be considered favourably when designing a dermatology trial as they can potentially enhance both recruitment and retention., Trial Registration Number: ISRCTN 12892056. Registered on October 15, 2018., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Objective: To assess the effectiveness of oral spironolactone for acne vulgaris in adult women., Design: Pragmatic, multicentre, phase 3, double blind, randomised controlled trial., Setting: Primary and secondary healthcare, and advertising in the community and on social media in England and Wales., Participants: Women (≥18 years) with facial acne for at least six months, judged to warrant oral antibiotics., Interventions: Participants were randomly assigned (1:1) to either 50 mg/day spironolactone or matched placebo until week six, increasing to 100 mg/day spironolactone or placebo until week 24. Participants could continue using topical treatment., Main Outcome Measures: Primary outcome was Acne-Specific Quality of Life (Acne-QoL) symptom subscale score at week 12 (range 0-30, where higher scores reflect improved QoL). Secondary outcomes were Acne-QoL at week 24, participant self-assessed improvement; investigator's global assessment (IGA) for treatment success; and adverse reactions., Results: From 5 June 2019 to 31 August 2021, 1267 women were assessed for eligibility, 410 were randomly assigned to the intervention (n=201) or control group (n=209) and 342 were included in the primary analysis (n=176 in the intervention group and n=166 in the control group). Baseline mean age was 29.2 years (standard deviation 7.2), 28 (7%) of 389 were from ethnicities other than white, with 46% mild, 40% moderate, and 13% severe acne. Mean Acne-QoL symptom scores at baseline were 13.2 (standard deviation 4.9) and at week 12 were 19.2 (6.1) for spironolactone and 12.9 (4.5) and 17.8 (5.6) for placebo (difference favouring spironolactone 1.27 (95% confidence interval 0.07 to 2.46), adjusted for baseline variables). Scores at week 24 were 21.2 (5.9) for spironolactone and 17.4 (5.8) for placebo (difference 3.45 (95% confidence interval 2.16 to 4.75), adjusted). More participants in the spironolactone group reported acne improvement than in the placebo group: no significant difference was reported at week 12 (72% v 68%, odds ratio 1.16 (95% confidence interval 0.70 to 1.91)) but significant difference was noted at week 24 (82% v 63%, 2.72 (1.50 to 4.93)). Treatment success (IGA classified) at week 12 was 31 (19%) of 168 given spironolactone and nine (6%) of 160 given placebo (5.18 (2.18 to 12.28)). Adverse reactions were slightly more common in the spironolactone group with more headaches reported (20% v 12%; p=0.02). No serious adverse reactions were reported., Conclusions: Spironolactone improved outcomes compared with placebo, with greater differences at week 24 than week 12. Spironolactone is a useful alternative to oral antibiotics for women with acne., Trial Registration: ISRCTN12892056., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/. We declare no support from any organisation other than the National Institute for Health and Care Research for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work; no other relationships or activities that could appear to have influenced the submitted work. AML has served as advisor, consultant, and/or investigator for research (funded to institution) and/or received honoraria for unrestricted educational events from Almirall, Eucerin, Galderma, GSK, La Roche-Posay, LEO Pharma, L’Oréal, Mylan, Origimm, and Proctor and Gamble., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Realist evaluation aims to address the knowledge to practice gap by explaining how an intervention is expected to work, as well as what is likely to impact upon the success of its implementation, by developing programme theories that link contexts, mechanisms and outcomes. Co-production approaches to the development of programme theories offer substantial benefits in addressing power relations, including and valuing different types of knowledge, and promoting buy-in from stakeholders while navigating the complex social systems in which innovations are embedded. This paper describes the co-production of an initial programme theory of how an evidence based intervention developed in Australia - called 'Palliative Care Needs Rounds' - might work in England and Scotland to support care home residents approaching their end of life., Methods: Using realist evaluation and iPARIHS (integrated Promoting Action on Research Implementation in Health Services) we sought to determine how contexts and mechanisms of change might shape implementation outcomes. Pre-intervention online interviews ( n  = 28) were conducted (February-April 2021), followed by four co-design online workshops with 43 participants (April-June 2021). The online interviews and workshops included a range of stakeholders, including care home staff, specialist palliative care staff, paramedics, general practitioners, and relatives of people living in care homes., Results: This methodology paper reports developments in realist evaluation and co-production methodologies, and how they were used to develop context, mechanisms, outcomes (CMOs) configurations, and chains of inference. The initial (pre-intervention) programme theory is used to illustrate this process. Two developments to iPARIHS are described. First, involving stakeholders in the collaborative co-design workshops created opportunities to commence facilitation. Second, we describe developing iPARIHS' innovation component, to include novel stakeholder interpretations, perceptions and anticipated use of the intervention as they participated in workshop discussions., Conclusions: This rapid and robust co-production methodology draws on interactive collaborative research practices (interviews, workshop discussions of data, illustrative vignettes and visual methods). These innovative and engaging methods can be packaged for online processes to develop, describe and interrogate the CMOs in order to co-produce a programme theory. These approaches also commence facilitation and innovation, and can be adopted in other implementation science and realist studies., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Macgregor, McCormack, Spilsbury, Hockley, Rutherford, Ogden, Soulsby, Mckenzie, Hanratty and Forbat.)

Introduction: Acne is one of the most common inflammatory skin diseases worldwide and can have significant psychosocial impact and cause permanent scarring. Spironolactone, a potassium-sparing diuretic, has antiandrogenic properties, potentially reducing sebum production and hyperkeratinisation in acne-prone follicles. Dermatologists have prescribed spironolactone for acne in women for over 30 years, but robust clinical study data are lacking. This study seeks to evaluate whether spironolactone is clinically effective and cost-effective in treating acne in women., Methods and Analysis: Women (≥18 years) with persistent facial acne requiring systemic therapy are randomised to receive one tablet per day of 50 mg spironolactone or a matched placebo until week 6, increasing to up to two tablets per day (total of 100 mg spironolactone or matched placebo) until week 24, along with usual topical therapy if desired. Study treatment stops at week 24; participants are informed of their treatment allocation and enter an unblinded observational follow-up period for up to 6 months (up to week 52 after baseline). Primary outcome is the Acne-specific Quality of Life (Acne-QoL) symptom subscale score at week 12. Secondary outcomes include Acne-QoL total and subscales; participant acne self-assessment recorded on a 6-point Likert scale at 6, 12, 24 weeks and up to 52 weeks; Investigator's Global Assessment at weeks 6 and 12; cost and cost effectiveness are assessed over 24 weeks. Aiming to detect a group difference of 2 points on the Acne-QoL symptom subscale (SD 5.8, effect size 0.35), allowing for 20% loss to follow-up, gives a sample size of 398 participants., Ethics and Dissemination: This protocol was approved by Wales Research Ethics Committee (18/WA/0420). Follow-up to be completed in early 2022. Findings will be disseminated to participants, peer-reviewed journals, networks and patient groups, on social media, on the study website and the Southampton Clinical Trials Unit website to maximise impact., Trial Registration Number: ISRCTN12892056;Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: Ensuring that a trial is designed so that its participants reflect those who might benefit from the results, or be spared harms, is key to the potential benefits of the trial reaching all they should. This paper describes the process, facilitated by Trial Forge, that was used between July 2019 and October 2020 to develop the INCLUDE Ethnicity Framework, part of the wider INCLUDE initiative from the National Institute for Health Research to improve inclusion of under-served groups in clinical research studies., Methods: Development of the Framework was done in seven phases: (1) outline, (2) initial draft, (3) stakeholder meeting, (4) modify draft, (5) Stakeholder feedback, (6) applying the Framework and (7) packaging. Phases 2 and 3 were face-to-face meetings. Consultation with stakeholders was iterative, especially phases 4 to 6. Movement to the next phase was done once all or most stakeholders were comfortable with the results of the current phase. When there was a version of the Framework that could be considered final, the Framework was applied to six trials to create a set of examples (phase 6). Finally, the Framework, guidance and examples were packaged ready for dissemination (phase 7)., Results: A total of 40 people from stakeholder groups including patient and public partners, clinicians, funders, academics working with various ethnic groups, trial managers and methodologists contributed to the seven phases of development. The Framework comprises two parts. The first part is a list of four key questions: 1. Who should my trial apply to? 2. Are the groups identified likely to respond in different ways? 3. Will my study intervention make it harder for some groups to engage? 4. Will the way I have designed the study make it harder for some groups to engage? The second part is a set of worksheets to help trial teams address these questions. The Framework can be used for any stage of trial, for a healthcare intervention in any disease area. The Framework was launched on 1st October 2020 and is available open access at the Trial Forge website: https://www.trialforge.org/trial-forge-centre/include/ ., Conclusion: Thinking about the number of people in our trials is not enough: we need to start thinking more carefully about who our participants are.

Introduction: Palliative and end-of-life care in care homes is often inadequate, despite high morbidity and mortality. Residents can experience uncontrolled symptoms, poor quality deaths and avoidable hospitalisations. Care home staff can feel unsupported to look after residents at the end of life. Approaches for improving end-of-life care are often education-focused, do not triage residents and rarely integrate clinical care. This study will adapt an evidence-based approach from Australia for the UK context called 'Palliative Care Needs Rounds' (Needs Rounds). Needs Rounds combine triaging, anticipatory person-centred planning, case-based education and case-conferencing; the Australian studies found that Needs Rounds reduce length of stay in hospital, and improve dying in preferred place of care, and symptoms at the end of life., Methods and Analysis: This implementation science study will codesign and implement a scalable UK model of Needs Rounds. The Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework will be used to identify contextual barriers and use facilitation to enable successful implementation. Six palliative care teams, working with 4-6 care homes each, will engage in two phases. In phase 1 (February 2021), stakeholder interviews (n=40) will be used to develop a programme theory to meet the primary outcome of identifying what works, for whom in what circumstances for UK Needs Rounds. Subsequently a workshop to codesign UK Needs Rounds will be run. Phase 2 (July 2021) will implement the UK model for a year. Prospective data collection will focus on secondary outcomes regarding hospitalisations, residents' quality of death and care home staff capability of adopting a palliative approach., Ethics and Dissemination: Frenchay Research Ethics Committee (287447) approved the study. Findings will be disseminated to policy-makers, care home/palliative care practitioners, residents/relatives and academic audiences. An implementation package will be developed for practitioners to provide the tools and resources required to adopt UK Needs Rounds., Registration Details: Registration details: ISRCTN15863801., Competing Interests: Competing interests: Not required., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: One of the top three research priorities for the UK clinical trial community is to address the gap in evidence-based approaches to improving participant retention in randomised trials. Despite this, there is little evidence supporting methods to improve retention. This paper reports the PRioRiTy II project, a Priority Setting Partnership (PSP) that identified and prioritised unanswered questions and uncertainties around trial retention in collaboration with key stakeholders., Methods: This PSP was conducted in collaboration with the James Lind Alliance, a non-profit making initiative, to support key stakeholders (researchers, patients, and the public) in jointly identifying and agreeing on priority research questions. There were three stages. (1) First an initial online survey was conducted consisting of six open-ended questions about retention in randomised trials. Responses were coded into thematic groups to create a longlist of questions. The longlist of questions was checked against existing evidence to ensure that they had not been answered by existing research. (2) An interim stage involved a further online survey where stakeholders were asked to select questions of key importance from the longlist. (3) A face-to-face consensus meeting was held, where key stakeholder representatives agreed on an ordered list of 21 unanswered research questions for methods of improving retention in randomised trials., Results: A total of 456 respondents yielded 2431 answers to six open-ended questions, from which 372 questions specifically about retention were identified. Further analysis included thematically grouping all data items within answers and merging questions in consultation with the Steering Group. This produced 27 questions for further rating during the interim survey. The top 21 questions from the interim online survey were brought to a face-to-face consensus meeting in which key stakeholder representatives prioritised the order. The 'Top 10' of these are reported in this paper. The number one ranked question was 'What motivates a participant's decision to complete a clinical trial?' The entire list will be available at www.priorityresearch.ie ., Conclusion: The Top 10 list can inform the direction of future research on trial methods and be used by funders to guide projects aiming to address and improve retention in randomised trials.