Objectives Clinical research in emergency and critical care is vital, but recruitment and consent are complex. Research may be conducted without prior consent when patients are critically ill, and interventions are time critical. Some patients may die before research participation can be discussed with relatives, leaving the bereaved unaware of their involvement. This study explored potential communication strategies for informing bereaved relatives when a patient has died following enrolment into an emergency or critical care study without prior consent.Design and setting A mixed-methods study using a telephone survey and semi-structured interviews conducted simultaneously. The survey was conducted within a National Health Service Trust in North West England with relatives of deceased study participants. Semi-structured interviews were conducted with bereaved relatives and research and clinical staff across the UK, and medical examiner (ME)/ME officers based in England and Wales. Quantitative data were analysed descriptively, and qualitative data were analysed using reflexive thematic analysis. Data were synthesised using a constant comparison approach.Participants 11 bereaved relatives completed the survey. 53 individuals (21 research and clinical staff, 18 relatives and 14 MEs/officers) participated in semi-structured interviews.Results Although many trials do not include a process for notifying bereaved relatives about research participation, most relatives valued the opportunity to learn about their family member’s participation, emphasising the importance of transparency and trust. However, some raised concerns over the potential burden of automatic disclosure by the ME service. Offering bereaved relatives the option to receive sensitively worded information about research involvement at an appropriate time, soon after death, was recommended.Conclusion Bereaved relatives should have the choice to be informed about research participation without prior consent. Our findings support the need for transparent and sensitive communication and will contribute to future guidance for the design and conduct of adult emergency and critical care studies.

Abstract Background Core outcome sets (COS) standardise the outcomes reported in clinical trials and research, reducing outcome heterogeneity and enabling evidence synthesis. Most neonatal COS have been developed in high-income country (HIC) contexts and may not reflect the priorities, health system capacities, or disease burden of low- and middle-income countries (LMICs). Kenya’s neonatal mortality rate remains high at 21 per 1000 live births, yet no COS exists for neonatal care and research in Kenya or, more broadly, in sub-Saharan Africa. This study aimed to develop a contextually appropriate COS for neonatal care and research in Kenya, and to assess the feasibility of adapting an existing HIC COS for use in an LMIC setting. Methods A mixed qualitative and consensus-based approach was used, guided by the COMET handbook. The process comprised three phases: a rapid review of outcomes reported in neonatal trials from sub-Saharan Africa compared with an existing HIC COS; qualitative stakeholder engagement through key informant interviews (KIIs) and focus group discussions (FGDs) with healthcare providers, national-level policymakers, and mothers of previously admitted neonates at two Kenyan hospitals representing urban and rural settings; and an in-person consensus workshop using the nominal group technique with 13 multidisciplinary stakeholders. Thematic analysis followed Braun and Clarke’s six-phase framework. Outcomes endorsed by ≥ 70% of consensus meeting participants were included in the final COS. Results Seventeen stakeholders participated in KIIs, and 15 mothers participated in two FGDs. Sixteen candidate outcomes were presented at the consensus meeting. Five outcomes achieved immediate universal consensus: survival, length of hospital stay, ability to feed/weight gain/growth, cognitive ability, and visual impairment/retinopathy of prematurity (RoP). Following discussion and voting, a further seven outcomes were endorsed: impact on mothers and wider family, financial costs to the mother, pain, adverse events due to medicines, respiratory distress, quality of life, and sepsis/infections. The final COS comprises twelve outcomes. Seven overlapped with the existing HIC COS, though with contextually adapted definitions. Five outcomes are Kenya-specific, reflecting the out-of-pocket payment structure, high comorbidity burden, and family-centred care priorities of the Kenyan health system. Conclusions Adapting an HIC neonatal COS for use in an LMIC context is feasible, but requires systematic definitional adaptation, engagement with existing local frameworks such as WHO Essential Newborn Care guidelines, and attention to diagnostic capacity constraints. The Kenya COS captures both clinical and life-impact outcomes, reflecting the priorities of diverse stakeholder groups including mothers. Realising its value requires phased implementation sensitive to urban–rural differences in facility capacity, investment in workforce training, and stronger collaboration between clinicians and researchers to ensure outcome measurement serves both care improvement and evidence generation. Trial registration This is not a clinical trial. Clinical trial number: not applicable.

Bone and joint infection in children can result in bone and joint damage, sepsis, and even death. Diagnosis is informed by the history, examination, and a suite of tests, including blood markers, radiographs, ultrasound, and MRI. This study aimed to identify the communication needs of families during diagnostic assessment of bone and joint infection. This was a qualitative study involving semi-structured interviews with children and families who had experienced diagnostic tests for bone and joint infection, and health professionals experienced in the care of affected children. A total of 21 families (four children; 21 parents) and 11 health professionals from 11 English and Welsh hospitals were interviewed. Data analysis was informed by thematic analysis. Families often felt highly anxious during diagnosis. Some described a disorderly diagnosis process, gaps or inconsistencies in information, and insensitive communication that contributed to their anxiety. Other families described more positive experiences, indicating how health professionals helped them feel prepared by providing an outline of timelines, the rationale for tests, and the potential need to adjust plans as new information became available. Participants recognized the importance of age-appropriate communication with children, and the involvement of play specialists in this process. The findings demonstrate the intense anxiety families experience during assessment of bone and joint infection, particularly when they are left to make sense of uncertainties by themselves, or when communication is unclear. Health professionals can support families during diagnosis by attending to both the information they provide and how it is provided, while acknowledging the uncertainties of the diagnosis process. Specifically, families valued explanations of the rationale for different clinical investigations and their timing, and advance discussion of the next steps and possible outcomes of diagnostic testing. When test results became available, families were also helped by clear follow-up plans, including in situations when the results were inconclusive. Cite this article: Bone Jt Open 2026;7(2):259–265.

Background It is crucial that the outcomes used in clinical effectiveness studies are relevant to patients. This relevance can be assured by patients participating with other key stakeholders in core outcome set (COS) studies, yet recruiting patients to such studies can be challenging. Objectives As no guidance currently exists to help COS developers create good COS invitations for patients, which are usually the first documents patients see when invited to participate in COS studies, the Good Research Invitation Study aimed to produce such guidance. Design Consensus meeting to agree on guidance for COS developers designing research invitations. Setting and participants Informed by findings from our previous qualitative study of patient and public opinions on COS study invitations, our team, which included a patient research partner, produced an initial set of candidate recommendations. An online consensus meeting was organised in the UK with 13 participants including patient research partners with and without COS study experience, COS developers, a representative from an ethics committee and experts in diversity, marketing and science communication. Through a process of discussion and voting, the initial set of recommendations was refined. Results From the initial 35 recommendations, consensus meeting participants agreed a final set of 22 recommendations. Some initial recommendations were removed as they were beyond the scope, while others were merged. The finalised recommendations focused on producing and user testing invitations, reaching the audience, engaging potential COS participants and considering what they might find appealing or off-putting, explaining and creating interest in the study, keeping the invitation simple and understandable, considering the amount of information to include and how to present it, alongside ensuring accessibility. Discussion during the meeting highlighted the importance of improving the accessibility of all participant-facing resources in COS studies, not just the invitations. Conclusion Through consensus, a set of recommendations has been agreed on for use by COS developers to enhance study invitations for patients. Further testing and refinement of the recommendations will improve their utility.

Background: Heart failure affects almost one million people in the UK and is increasing in prevalence. Many drugs used to treat heart failure impair renal function and can lead to hospitalisation. Adverse drug problems can be partially mitigated through regular renal monitoring and optimising of drug dose and choice to prevent deterioration of kidney function. This protocol describes part of a wider research programme: personalising renal function monitoring and interventions in people living with heart failure (RENAL-HF). Aim: The aim of RENAL-HF is to develop improved processes in primary care to manage kidney health in people living with heart failure. Method: The protocol covers gathering views of healthcare professionals, patients, and carers, to co-develop a care pathway for use in primary care. Using a mixed-methods approach, the work comprises the following six stages: (1) understanding current practice of optimising heart failure treatment while preserving renal function; (2) co-designing a care pathway including personalised renal function monitoring, thresholds for intervention and clinical guidelines; (3) decision making to identify elements that will support the care pathway; (4) developing training materials for primary care to enable use of the care pathway; (5) testing the usability of the prototype care pathway; and 6) a feasibility and acceptability study to inform the pre-clinical development and usability of the care pathway ahead of a cluster randomised control trial (RCT). Conclusion: All stages will elicit evidence from primary care practices, practitioners, and patients with which to assess and refine the care pathway. The evidence will inform how algorithm-guided individualised treatment can be implemented to improve the outcomes of patients with heart failure.

Aims:Bone and joint infection in children can result in bone and joint damage, sepsis, and even death. Diagnosis is informed by the history, examination, and a suite of tests, including blood markers, radiographs, ultrasound, and MRI. This study aimed to identify the communication needs of families during diagnostic assessment of bone and joint infection. Methods:This was a qualitative study involving semi-structured interviews with children and families who had experienced diagnostic tests for bone and joint infection, and health professionals experienced in the care of affected children. A total of 21 families (four children; 21 parents) and 11 health professionals from 11 English and Welsh hospitals were interviewed. Data analysis was informed by thematic analysis. Results:Families often felt highly anxious during diagnosis. Some described a disorderly diagnosis process, gaps or inconsistencies in information, and insensitive communication that contributed to their anxiety. Other families described more positive experiences, indicating how health professionals helped them feel prepared by providing an outline of timelines, the rationale for tests, and the potential need to adjust plans as new information became available. Participants recognized the importance of age-appropriate communication with children, and the involvement of play specialists in this process. Conclusion:The findings demonstrate the intense anxiety families experience during assessment of bone and joint infection, particularly when they are left to make sense of uncertainties by themselves, or when communication is unclear. Health professionals can support families during diagnosis by attending to both the information they provide and how it is provided, while acknowledging the uncertainties of the diagnosis process. Specifically, families valued explanations of the rationale for different clinical investigations and their timing, and advance discussion of the next steps and possible outcomes of diagnostic testing. When test results became available, families were also helped by clear follow-up plans, including in situations when the results were inconclusive.

This paper explores the experiences of the parents of gender-diverse children in terms of the support they sought for their child, as well as the support they sought for themselves. Examining the ways in which they balanced the emotional labour of being a parent advocating for their child, and protecting their child from perceived and actual harms, is important in understanding the care that these carers may also require. The findings in this paper come from a longitudinal study and focus on the first interviews conducted with 39 parents of gender-diverse young people aged between 5 and 15 years, none of whose children had yet been seen by a gender service. Three main themes were generated: 1. Listening and learning – (a) Voicing their uncertainty, (b) Listening lessens uncertainty, (c) Being led by their child; 2. Layers of support – (a) Family and friends, (b) Support groups, (c) GPs and Gender Identity Development Service, (d) Doing their own research; and, 3. Isolation. Findings from this paper highlight a gap within the healthcare system where parents often navigate their way through heretofore unknown health service systems with very little guidance from their peers or healthcare professionals. It is clear that parents require assistance in engaging with these systems to best meet the various needs of their child and family. The ways in the support required by parents and children might change or shift over time will be examined longitudinally in future papers. Adding to our understanding of how parents of gender-diverse children experience access to support structures and the ways advocate for their child. Narratives from the first interviews in a longitudinal study of families in the UK whose children were on the waitlist of the national gender service. Themes of ‘listening and learning’, ‘layers of support’, and ‘isolation’ demonstrate the various experiences of parents of gender-diverse children. Parents’ narratives made clear that people providing care within support groups, GP services and gender services need to be able to meet the parents where they’re at, acknowledging the emotional labour required to find these services.

Background The use of core outcome sets (COSs) in health research is widely recommended. COSs are developed with input from key decision makers, patients being a vital group to ensure COS relevance. However, recruitment to COS studies can be challenging. Objectives The study aimed to explore what patients and the public think of COS study invitations, which are usually the first document a patient reads about a COS study. Design Qualitative study involving focus groups and interviews. Analysis of transcribed data drew on reflexive thematic analysis. Participants and setting Focus groups and interviews were conducted with a diverse range of patients and the public (n=31) from community and patient groups in North West England, exploring their perceptions of a sample of COS study invitations. Participants were eligible if aged over 18 years, they could speak English and had never previously participated in a COS study. Results Themes identified included understanding, engagement, safety and accessibility. Participants were concerned about excessive information in the invitations which made them confused. Fear of cybercrime caused numerous concerns and participants were reluctant to click on links or attachments. Trust in the people sending the invitations was key. Participants wanted to see messages that COS studies had a meaningful purpose to feel their contributions were valuable. They were keen to contribute to improving future ‘treatment’ but less motivated to improve ‘research’. Messages that evoked a feeling of connection with others who they could relate to were positively regarded. Participants also highlighted ways that invitations could be made more accessible. Conclusion COS invitations can present numerous challenges for potential participants, but our study indicates ways that COS developers can address these challenges and make their invitations more appealing to potential participants. As part of the wider Good Research Invitation Study the findings have been used to inform guidance on designing a good COS invitation

OBJECTIVES:i) to explore experiences of boys and parents/guardians regarding surgical treatment options for lichen sclerosus et atrophicus (LS/BXO); ii) to gather surgeons' perspectives to inform design of a randomized controlled trial (RCT) comparing preputioplasty with intralesional steroids (PIT) versus circumcision to treat LS. PATIENTS AND METHODS:Semi-structured qualitative interviews conducted with 20 boys (aged 8-18 years) and their families who had previously undergone PIT (n = 15) or circumcision (n = 6). Focus groups/interviews were held with 17 surgeons. Participants were recruited from a regional children's hospital and professional networks. Data were analysed thematically. RESULTS:Patients and families commonly misunderstood foreskin function and surgical options. Delayed symptom recognition and limited awareness of PIT were frequent. Families weighed up immediate versus long-term outcomes when making treatment decisions: some chose circumcision, perceiving it as a definitive resolution, others preferred PIT for foreskin preservation. Boys opted for PIT due to aesthetic concerns, families were concerned about long-term impacts of circumcision. Surgeons supported offering PIT but emphasised the need for RCTs to confirm its effectiveness. Satisfaction was high in both patient groups. Boys, families, and surgeons identified factors they considered important outcomes, which they believed should be measured in future evaluations of both treatments. CONCLUSION:This study highlights the importance of offering the option to retain the foreskin during surgical treatment for LS. It emphasises the need for clinicians to understand patient preferences and calls for better education on normal foreskin anatomy and surgical options, as well as further research into PIT through a RCT.

Aims:Bone and joint infections (BJI) in children are rare but can be serious. Differentiating BJI from other conditions with similar symptoms is critical. Advanced imaging (ultrasound scans (USS) and MRI) is often required to confirm the diagnosis. The differing merits of imaging type and regional variation in access to advanced imaging can lead to diagnostic uncertainty and treatment variation. The aim of this study is to evaluate the diagnostic accuracy of MRI and USS for the investigation of BJI in children, and develop and validate prediction models to aid the diagnosis of BJI in children. A nested qualitative sub-study will explore acceptability of the imaging to children, parents, and health practitioners. Methods:A multicentre retrospective cohort of children (aged < 16 years) with suspected diagnosis of BJI will be used to estimate the diagnostic accuracy of the two imaging methods and develop the prediction models. The models will be evaluated in a second cohort of prospectively recruited children. Diagnostic test accuracy will be estimated overall, and separately for children aged under and over five years. The prediction models will be fit using logistic regression, with candidate predictors chosen based on clinical plausibility and from a review of the literature. Continuous predictors will be examined for non-linearity with confirmed BJI using fractional polynomials. Multiple imputation will be used to replace missing values. Internal validation will be carried out using bootstrapping. Model performance will be assessed with discrimination and calibration. Discussion:Ethical approval for this study (registration: ISRCTN15471635) was granted (REC reference 23/WM/0027). Informed consent is being obtained from participants in the prospective cohort and the qualitative sub-study. Study findings will be published in an open access journal and presented at relevant national and international conferences. Relevant charities and associations are being engaged to promote awareness of the project.

This study aimed to identify the information and support needs of children and their families during diagnostic investigations for paediatric osteomyelitis. Qualitative study involving semi-structured interviews with families who had experienced investigations for paediatric osteomyelitis and health professionals. Data analysis was informed by thematic analysis. Twenty-one families (4 children; 21 parents) and 11 health professionals from 11 English National Health Service (NHS) trusts and a Welsh health board were interviewed. Families often felt highly anxious during diagnosis. Some families described a disorderly process, gaps or inconsistencies in information, and insensitive communication that contributed to their anxiety. However, other families described more positive experiences, indicating how health professionals helped them feel prepared by providing an outline of the likely timelines, the rationale for different investigations and the potential need to adjust plans when new information became available. Both health professionals and families recognized the importance of direct and age-appropriate communication between health professionals and children, and the involvement of play specialists to communicate with children. This is the first study to describe experiences of communication in suspected paediatric osteomyelitis. The findings demonstrate the importance of health professionals helping to prepare families for the diagnostic journey and underline how information provision and communication can influence the extent to which families experience anxiety and uncertainty. The findings are broadly supportive of previously published recommendations that aim to assist health professionals with the challenges of communication with patients in inherently uncertain and fluid diagnostic contexts.

BackgroundBehaviour change interventions delivered in real-world settings could be vulnerable to threats to internal and external validity if methodological considerations are overlooked. The primary dental care setting is a difficult environment within which to deliver research protocols presenting unique challenges for robust scientific research delivery. Intervention fidelity strategies are an important mechanism to improve the scientific rigor of such studies. Feasibility studies provide a vital opportunity to refine and optimise research processes and implementation strategies before embarking on larger scale projects. This paper sets out the development of a comprehensive intervention fidelity strategy guided by The National Institutes of Health Behavior Change Consortium.(BCC) recommendations.MethodUsing observations (53 h) and qualitative interviews (17 patient interviews and 2 staff interviews) conducted during the delivery of the RETURN feasibility study (InteRventions to rEduce inequaliTies in the Uptake of Routine deNtal care), an intervention fidelity strategy was developed for use in the RETURN main trial.ResultsA comprehensive intervention fidelity strategy was developed, structured around the five domains of the BCC's recommendations (design, training, delivery, receipt, enactment) and attending to the goals pertaining to each of those domains. This paper sets out the fidelity strategy implemented in the RETURN main trial.Implications and conclusionsThe RETURN fidelity strategy was influenced by the unique research environment the primary dental care setting presents. The strategy could serve as a blueprint to other researchers conducting research in similar settings. It is also intended that this strategy is read alongside the RETURN results upon their publication.Trial registrationISRCTN10853330, registered: 07/10/2019.

Currently, the most frequently used treatment for acute appendicitis in children in the United Kingdom (UK) is an appendicectomy. However, there is increasing scientific and patient interest and research into non-operative treatment of appendicitis. Despite a number of non-randomised studies in children and randomised studies in adults, comparative outcomes of non-operative treatment and appendicectomy in comparable groups of children remain unknown. Following the successful completion of a feasibility study, we now aim to perform a UK-based multi-centre open-label randomised controlled trial (RCT) to investigate the clinical and cost-effectiveness of non-operative treatment pathway of acute uncomplicated appendicitis in children compared with appendicectomy. Non-inferiority RCT with internal pilot, health economic evaluation and qualitative communication sub-study. The study is conducted in England, Northern Ireland, Scotland and Wales at both specialist children’s hospitals and district general hospitals. Children (aged 4–15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Sample size is 376 participants, recruited by surgeons and supported by research staff and randomised with a 1:1 allocation ratio to either non-operative treatment pathway (intervention) or appendicectomy (control). Participants in the intervention arm are treated with antibiotics, analgesia and regular clinical assessment to ensure clinical improvement. Participants in the control arm receive appendicectomy. Randomisation is minimised by age, sex, duration of symptoms and centre. The primary end-point is a composite outcome of treatment success at 1 year following randomisation. Secondary outcomes include: duration of hospital stay, measures of recovery from acute appendicitis, complications, need for further treatment, persistent symptoms, health care resource use, quality of life and costs. Adverse events, serious adverse events and suspected unexpected serious adverse events are collected directly on the database and by paper form up to 12-month visit. Primary outcome will be analysed on a non-inferiority basis using a 20

Objectives Clinical trials are needed to advance interventions such as chemoprevention that have potential to reduce the risk of malignant transformation in individuals with oral potentially malignant disorders. We explored the perspectives of those screened or invited to join an early phase clinical trial (the SAVER trial: Sodium valproate for the epigenetic reprogramming of high-risk oral epithelial dysplasia). Our objectives were to inform the SAVER trial while it was ongoing and to provide insights for future trials and chemoprevention therapy development more broadly.Design Qualitative study involving audio-recorded, semistructured interviews. Analysis of transcribed interviews drew on thematic approaches.Setting Five UK-based sites involved in SAVER.Participants Purposive sample of individuals (n=20) with suspected or diagnosed oral epithelial dysplasia (OED) who were approached about SAVER.Results Most interviewees readily accepted that OED warranted preventive treatment and were positive about the potential of chemoprevention. However, they were often concerned about the side effects of the trial medication, and together with a dislike of biopsies and a perception that the trial might disadvantage treatment, these concerns made some hesitant to participate in SAVER. Interviewees indicated that the communication of staff influenced their understanding and experience of the trial and identified several opportunities for enhancing these aspects.Conclusions In indicating that individuals at risk of malignant transformation are accepting of chemoprevention in principle, our findings are supportive of future research on chemoprevention for this group. The findings also draw attention to the crucial role of communication in recruitment to chemoprevention trials. We provide recommendations to support staff during recruitment and enhance individuals’ experience of the trial.Trial registration number ISRCTN12448611; Pre-results.

Aims: The Bracing Adolescent Idiopathic Scoliosis (BASIS) study is a randomized controlled non-inferiority pragmatic trial of ‘full-time bracing’ (FTB) compared to ‘night-time bracing’ (NTB) for the treatment of adolescent idiopathic scoliosis (AIS). We anticipated that recruiting patients to BASIS would be challenging, as it is a paediatric trial comparing two markedly different bracing pathways. No previous studies have compared the experiences of AIS patients treated with FTB to those treated with NTB. This qualitative study was embedded in BASIS to explore families’ perspectives of BASIS, to inform trial communication, and to identify strategies to support patients treated in a brace. Methods: Semi-structured interviews were conducted with parents (n = 26) and young people (n = 21) who had been invited to participate in BASIS at ten of the 22 UK paediatric spine services in hospitals recruiting to BASIS. Audio-recorded interviews were transcribed and analyzed thematically. Results: Families viewed their interactions with BASIS recruiters positively, but were often confused about core aspects of BASIS, such as the aims, expectations of bracing, and the process of randomization. Participants typically expressed a preference for NTB, but recruiters may have framed NTB more favourably. Patients and parents reported challenges wearing a brace, such as physical discomfort, feelings of self-consciousness, difficulty participating in physical activities, and strain on financial resources to support brace use. Patients in FTB reported more pronounced challenges. While families valued health professional support, they felt there was a lack of social, emotional, and school support, and relied on online resources, as well private counselling services to address this need. Conclusion: The findings informed the development of resources and strategies, including guidance for schools and the recommendations in this paper, to support patients to wear NTB and FTB as prescribed. The results indicated opportunities for recruiters to enhance trial communication in ways that could improve informed consent and recruitment to BASIS, and inform future trials of bracing. Cite this article: Bone Jt Open 2025;6(2):135–146.

ObjectiveTo determine the feasibility and acceptability of integrating a remote, personalised, collaborative, and flexible exercise programme into the head and neck cancer (HNC) care pathway.DesignA single arm mixed-methods feasibility study across two UK NHS hospitals.ProcedureEligible HNC patients (aged ≥ 16 years old, treated with curative intent and classified as low/medium risk according to an exercise risk stratification tool) were invited to participate between diagnosis and 8 weeks post-treatment. Patients treated with palliative intent and those identified as high risk on an exercise risk stratification tool were excluded. Following initial assessment, Cancer Exercise Specialists (CESs) and patients collaboratively devised a personalised exercise programme based on a needs analysis, preferences and goals, and informed by physical activity cancer guidelines and theory. CESs were trained in behaviour change techniques. The intervention was flexible and delivered remotely across 8 weeks, with weekly meetings and texts, and an exercise maintenance plan agreed in the final session.OutcomesEligibility, recruitment, retention and exercise adherence were primary outcomes. Quantitative outcomes included quality-of-life, fatigue and physical activity questionnaires and physical fitness tests. A qualitative sub-study explored patients’ and healthcare professionals’ (HCPs’) views on feasibility and acceptability.Results98% of patients screened were eligible; 107 patients were approached, and 76 consented (71%). Most (43%) were recruited pre-treatment. Three quarters were male and just over half had oropharyngeal cancer. Thirteen patients (17.1%) were withdrawn due to ill-health. Twenty-three (30.3%) patients dropped out, 13 after assessment but before the intervention, and ten during the intervention. Forty patients (52.6%) completed the intervention. Three quarters of exercise sessions were completed as prescribed. Patient interviews found the flexible, personalised approach valuable. Those not identifying as an ‘exerciser’ found the intervention more difficult to understand. The need for more education for both HCPs and patients regarding the benefits of exercise and its ‘fit’ within the HNC pathway was highlighted.ConclusionThis is a feasible and acceptable intervention, but some adjustments are required, to improve acceptability, recruitment processes, retention and adherence, before examining effectiveness in a definitive trial.Clinical Trial Registrationhttps://www.isrctn.com/ISRCTN82505455, identifier ISRCTN82505455.

Clinical research in intensive care units (ICUs) is essential for improving treatments for critically ill patients. However, invitations to participate in clinical research in this situation pose numerous challenges. Studies are frequently initiated within a narrow time window when patients are often unconscious and unable to consent. Consultations or consent discussions must therefore be held with consultees or representatives, usually the patient's relatives. Conversations about research participation in this setting may be difficult, as relatives are often overwhelmed and may feel uneasy about making decisions on behalf of their relatives. In some circumstances, legislation allows doctors to act as consultees or representatives to enrol patients in research. However, there is little good quality evidence on UK stakeholders' perspectives to inform how recruitment is carried out in ICU studies. The Perspectives Study collected evidence on the views of over 1400 stakeholders, including patients, relatives and healthcare practitioners, many of whom had first-hand experience of ICU treatment and research. This evidence was used to inform good practice guidance on recruitment of critically ill patients to research. Established social science methods and empirical ethics were employed to reflect the interests of stakeholders and justify recommendations. This guidance aims to bridge the gap between the legal frameworks and the realities of ICU studies and to ensure that research recruitment processes reflect the views of patients and families. Researchers and an expert Advisory Group brought different perspectives to interpreting the evidence to develop the guidance. In this article we present guidance for future ICU studies.

BACKGROUND:Patients from socioeconomically disadvantaged backgrounds are underserved in randomised controlled trials, yet they experience a much greater burden of disease compared with patients from socioeconomically advantaged areas. It is crucial to make trials more inclusive to ensure that treatments and interventions are safe and effective in real-world contexts. Improving how information about trials is verbally communicated is an unexplored strategy to make trials more inclusive. This study examined how trials are communicated verbally, comparing consultations involving patients from the most and least socioeconomically disadvantaged areas.METHODS:Secondary qualitative analysis of 55 trial consultation transcripts from 41 patients, sampled from 3 qualitative studies embedded in their respective UK multi-site, cancer-related randomised controlled trials. Patients living in the most and least socioeconomically disadvantaged areas, defined using English Indices of Multiple Deprivation decile scores, were purposively sampled. Analysis was largely thematic and drew on the constant comparison method.RESULTS:Recruiters communicated clinical uncertainty in a similar way for patients living in different socioeconomic areas. Consultations with disadvantaged patients were, on average, half the duration of those with advantaged patients, and tended to involve recruiters providing less in-depth explanations of trial concepts, used phrasing that softened trial arm risks, and described trial processes (e.g. randomisation) using informal or metaphorical phrasing. Disadvantaged and advantaged patients differed in the concerns they expressed; disadvantaged patients voiced fewer concerns and asked fewer questions but were also less likely to be invited to do so by recruiters.CONCLUSION:Interactions about trials unfolded in different ways between patients living in different socioeconomic areas, likely due to both patient- and recruiter-related factors. We present considerations for recruiters when discussing trials with patients from socioeconomically disadvantaged backgrounds, aimed at enhancing trial communication. Future research should examine disadvantaged patients' and recruiters' experiences of verbal trial communication to inform guidance that addresses the needs and preferences of underserved groups.

Core outcome set (COS) development and use enhances comparability of research findings. It may also enhance the translation of research into practice and reduce research waste. However, there is limited involvement of stakeholders from low- and middle-income countries (LMICs) in COS development and use. In this study, we explored the experiences of researchers in COS development projects who included stakeholders from LMICs. Online survey conducted in English of 70 COS developers from HICs who had included LMIC stakeholders in the process of developing a COS, published before the end of 2019. Respondents were identified from the COMET database and sent a link to the survey via a personalised email. Quantitative data were analysed using simple descriptive statistics. Qualitative data analysis was based on qualitative content analysis. There were 37 respondents yielding a 53% overall response rate. Analysis was limited to the responses related to 29 COS developed in the years 2015 to 2019, to reduce the potential for recall bias for earlier COS. Most respondents 20/29 (69%) were researchers. Determining ‘what to measure’ was reported as the most common stage of inclusion of LMIC stakeholders. Respondents cited (24/29, 83%) their ongoing collaborations with LMIC stakeholders such as clinicians or researchers as their main rationale for including LMICs stakeholders and reported that translation of the Delphi into languages other than English may be useful to enhance wider stakeholder participation. Involvement of LMIC stakeholders only in the later stages of COS development, lack of adequate resources to support their involvement, and lack of networks and contacts were thought to limit fuller participation of stakeholders from LMICs. To improve the involvement of LMIC stakeholders in COS development and use, COS developers need to raise awareness on the utility of COS. The need for and feasibility of translation into multiple languages warrants further discussion.