Bridget Young

Aims: Recruitment to randomized controlled trials (RCTs) remains a widely recognized challenge, particularly in surgical and paediatric contexts. The British Orthopaedic Surgery Surveillance (Big BOSS) trial aimed to compare surgical approaches for treating severe stable slipped capital femoral epiphysis (SCFE), a relatively rare but serious adolescent hip condition. Despite national estimates suggesting feasibility, recruitment fell significantly short of targets, and Big BOSS was discontinued. This embedded qualitative study explored the perspectives of consultant surgeons to understand the barriers that contributed to the low recruitment for the trial. Methods: Semistructured interviews were carried out with 24 consultant surgeons from 21 NHS sites, including recruiting, non-recruiting, and setup sites. Participants were purposely sampled to ensure variation in experience and involvement in trials. Data were analyzed inductively and thematically, guided by constant comparative methods. Results: Five overarching themes were identified: 1) limited availability of eligible patients, with many cases of SCFE either unstable, too mild or managed outside trial centres; 2) challenges in interpreting and standardizing the eligibility criteria; 3) difficulty maintaining clinical equipoise, as surgeons often relied on personal experience and preferred treatment pathways; 4) systemic and logistical barriers, including limited research infrastructure, scheduling complexity, and demands on the resources for trials; and 5) patient-level factors, such as aversion to invasive procedures, logistical constraints, and predetermined expectations of treatment. Together, these themes revealed how clinical, practical, and ethical tensions limited participation in the trial. Conclusion: This nested qualitative study highlighted the multifaceted barriers to recruitment in complex surgical RCTs, and showed how embedded qualitative research can help to uncover these challenges and guide the management decisions for trials. The findings emphasize the value of a qualitative investigation to understand the underlying processes and challenges within a trial. This approach facilitates the development of adaptive recruitment strategies, and supports more realistic planning when designing RCTs involving rare conditions or preference-sensitive treatments. Cite this article: Bone Joint J 2026;108-B(11):1371–1378.

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

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.

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.

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. Cite this article: Bone Jt Open 2026;7(2):259–265.

Background: 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. Methods: 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% non-inferiority margin to test the hypothesis that non-operative treatment pathway is non-inferior to appendicectomy. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative sub-study. This will include recording of recruitment consultations, which will inform future interventions to optimise recruitment. We have involved children, young people and parents in study design and delivery. Discussion: This RCT will allow determination of the comparative clinical and cost-effectiveness of non-operative treatment pathway compared to appendicectomy for children with uncomplicated acute appendicitis in the UK. Trial status: First planned enrolment—December 2022, first actual recruit—March 2022, current status of trial—open to recruitment. Trial registration: ISRCTN16720026 . Registered on July 28, 2021.

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: 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.Cite this article: Bone Jt Open 2025;6(6):677–684.