Respiratory infections are easily transmitted within care homes. Within a clinical trial (called AFRI-c), which tested the effectiveness of high-efficiency-particulate-air (HEPA) filters to reduce respiratory infections in care home residents, we conducted a mixed-methods process evaluation. We aimed to understand their acceptability, fidelity, and implementation to aid interpretation of the effectiveness findings. We used qualitative remote and face-to-face interviews with staff (n = 25), residents (n = 20), and relatives (n = 12) from care homes (n = 22) in the AFRI-c trial. We purposively sampled homes for variation in size, nursing or residential provision, and deprivation. We used reflexive thematic analysis, drawing on normalisation process theory to understand implementation. We used staff questionnaires (n ranges from 191 to 351 depending on questionnaire) and resident (n = 1158) questionnaires with descriptive and regression analyses. We used the triangulation protocol to integrate qualitative and quantitative findings. The use of HEPA filters became normalised, although some residents disliked the draught. Self-reported intervention fidelity was high, which is important context for interpreting the trial's null outcome for infection reduction. HEPA filters made no difference to resident or staff satisfaction with the care home environment. We found no evidence that using HEPA filters changed infection control and prevention practices. While staff felt it was a priority to prevent respiratory infections, residents were more concerned about quality of life and care. Our mixed methods process evaluation of the AFRI-c trial found the use of HEPA filters was acceptable, with high levels of adherence and low levels of contamination, suggesting that the null trial results were not due to poor adherence. Some effort was required to ensure they were kept on. Approaches to data collection may have caused under-reporting of mild infections. We should not assume that infection prevention is always a priority for residents.

Background:Recurrence or persistence of symptoms after interventions to treat stress urinary incontinence in women is common, but without robust evidence to base treatment recommendations. Objectives:To investigate whether endoscopic or surgical treatments for stress urinary incontinence in women are effective and cost-effective. Design:A multicentre, unblinded, parallel-group randomised controlled trial. Setting:Fifteen centres across the United Kingdom. Participants:Adult women with recurrent or persistent stress urinary incontinence. Intervention:Individual randomisation to endoscopic (urethral bulking) or surgical (autologous sling, colposuspension, artificial urinary sphincter) interventions. Women randomised to surgery chose their operative intervention. Main outcomes:Primary outcome self-reported International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form at 1 year post randomisation. Secondary outcomes included International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form, Patient Global Impression of Improvement and Pelvic Organ Prolapse/Urinary Incontinence Sexual questionnaires up to 3 years post randomisation, operative assessment measures and adverse events, cost-effectiveness from National Health Service and societal perspectives (quality-adjusted life-years and International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form) at 1 year, and a secondary care perspective (quality-adjusted life-years) at 3 years. Semistructured qualitative interviews at baseline (post randomisation), follow-up (3-6 months) and longer-term (12 and 36 months), to explore stress urinary incontinence generally, the acceptability and attitudes to treatments and to improve understanding of outcomes. Qualitative interviews with clinicians at baseline were focused on potential difficulties of recruitment and optimising patient-facing information and training materials for clinicians. Results:Fifty-five women were deemed eligible after screening (n = 328 screened) from October 2019 to June 2022. Twenty-four eligible women consented, and 23 were randomised (between January 2020 and July 2022) from 8 sites with the average age of 57 years (standard deviation: 10.7) and all self-reported 'white' ethnicity. Participants reported a median International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form score at baseline of 16 (interquartile range: 13-19) and mean post-void residual volume of 4.64 ml (standard deviation: 8.45). Eleven participants received their allocated intervention, 2 participants withdrew prior to receiving their intervention and 10 were waiting for their intervention when the study closed. The most common reason for declining participation was a treatment preference (n = 14). Recruitment training sessions and recruitment tips documents were developed and implemented to address challenges centred around patient treatment preferences and clinicians' equipoise. However, the most important recruitment challenge was the low number of eligible patients, driven primarily by the COVID-19 pandemic preventing referrals and surgery, and related wider issues in the National Health Service which led to study closure in January 2023. Conclusion:In its early stages, the initial recruitment rate was on target (four participants randomised in the first 3 months of recruitment), but once the pandemic started, the study was unable to recruit and so closed early. The main limitation was the occurrence of the global pandemic soon after the commencement of recruitment, profoundly affecting service delivery and patient presentations. Under normal healthcare service conditions, the study may be deliverable. Limitations:Failure to recruit under pandemic conditions rendered the study unfeasible. Future research:Practical experience with the study and development of patient-facing and staff training materials will help delivery of the study once patient referrals and healthcare services fully return to normal. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 17/95/03.

Background: Implant-based breast reconstruction (IBBR) is a rapidly evolving technique and evidence to support best practice is lacking. Randomised controlled trials (RCTs) in breast reconstruction are needed but are challenging due to patient and surgeon preference. Feasibility work prior to a full-scale trial is therefore essential. The Best-BRA (Is subpectoral or pre-pectoral implant placement Best in immediate BReAst reconstruction?) pilot RCT aimed to determine whether it would be possible to recruit and randomise women to a study comparing two different approaches to implant-based breast reconstruction in the UK. Methods: Best-BRA was a pragmatic, multicentre external pilot RCT in which women >18 who elected to undergo immediate IBBR for breast cancer or risk reduction and were considered eligible for both pre and subpectoral techniques by their operating surgeon were randomised 1:1 to either technique. Surgeons were permitted to perform the procedure according to their standard practice (e.g. patient/implant selection; use/type of mesh). The primary outcomes related to the feasibility of a future large-scale trial and included the number of participants who were recruited and consented to be randomised. A QuinteT Recruitment Intervention (QRI) was embedded to explore anticipated recruitment challenges and provide practical support for sites and the study team. The QRI involved two phases. In Phase 1, the sources of recruitment difficulties were investigated by: mapping eligibility and recruitment pathways; recording recruitment discussions between clinicians and patients; semi-structured interviews with the study team and site staff; observing investigator meetings; reviewing screening logs and study documentation. Phase 2 involved supportive and responsive feedback to the study team and site staff and the implementation of recruitment intervention strategies informed by Phase 1. Phases 1 and 2 were undertaken in an iterative and cyclical manner. Results: Best-BRA opened on 19/7/21 after a 20-month delay in set-up due to COVID-19. The average time to site opening was 310 days (range 71-557). A total of 12 UK sites were opened and 11 participants randomised over a 19-month period. The trial was closed in January 2023 due to poor recruitment. A future large-scale trial comparing pre and subpectoral IBBR in the UK was not considered feasible. Screening logs revealed that only 22% participants screened were considered suitable for both IBBR techniques and, of these potentially eligible participants, only 41% were approached to take part in Best-BRA. Qualitative data from the QRI indicated both the lower-than-expected number of eligible patients and acceptability rates were due to a rapid adoption of pre-pectoral IBBR in the UK leading to a loss of equipoise. This change in practice was due to surgeons’ perception that pre-pectoral reconstruction was a ‘better’ technique for patients. It was perceived as quicker and easier to perform and with improved cosmetic outcomes and less post-operative pain. The lack of high-quality evidence to support this change was acknowledged but surgeons felt the limited evidence that prepectoral IBBR was ‘no worse’, coupled with their personal experience of benefit was sufficient to change practice. This was coupled with a move away from IBBR techniques more generally due to high complication rates and poor long-term outcomes. These factors were further exacerbated by COVID-19-related delays and pressures and were beyond addressing by the QRI. Conclusions: A large-scale RCT comparing pre and subpectoral IBBR is not feasible in the UK due to the widespread adoption of prepectoral reconstruction despite a lack of high-quality evidence. Prepectoral IBBR needs to be robustly evaluated and well-designed, large-scale studies such as iPREPARE will be essential support best practice. Citation Format: Kirsty Roberts, Clare Clement, Nicola Mills, Shelley Potter. Is it possible to recruit and randomise participants to an implant-based breast reconstruction trial in the UK? Results from the Best-BRA Study [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P3-09-15.

Introduction Traumatic pneumothoraces are present in one of five victims of severe trauma. Current guidelines advise chest drain insertion for most traumatic pneumothoraces, although very small pneumothoraces can be managed with observation at the treating clinician’s discretion. There remains a large proportion of patients in whom there is clinical uncertainty as to whether an immediate chest drain is required, with no robust evidence to inform practice. Chest drains carry a high risk of complications such as bleeding and infection. The default to invasive treatment may be causing potentially avoidable pain, distress and complications. We are evaluating the clinical and cost-effectiveness of an initial conservative approach to the management of patients with traumatic pneumothoraces.Methods and analysis The CoMiTED (Conservative Management in Traumatic Pneumothoraces in the Emergency Department) trial is a multicentre, pragmatic parallel group, individually randomised controlled non-inferiority trial to establish whether initial conservative management of significant traumatic pneumothoraces is non-inferior to invasive management in terms of subsequent emergency pleural interventions, complications, pain, breathlessness and quality of life. We aim to recruit 750 patients from at least 40 UK National Health Service hospitals. Patients allocated to the control (invasive management) group will have a chest drain inserted in the emergency department. For those in the intervention (initial conservative management) group, the treating clinician will be advised to manage the participant without chest drain insertion and undertake observation. The primary outcome is a binary measure of the need for one or more subsequent emergency pleural interventions within 30 days of randomisation. Secondary outcomes include complications, cost-effectiveness, patient-reported quality of life and patient and clinician views of the two treatment options; participants are followed up for 6 months.Ethics and dissemination This trial received approval from the Wales Research Ethics Committee 4 (reference: 22/WA/0118) and the Health Research Authority. Results will be submitted for publication in a peer-reviewed journal.Trial registration number ISRCTN35574247.

Background Childhood respiratory tract infections (RTIs) are common and can lead to unnecessary antibiotic use and antimicrobial resistance. The CHIldren with COugh (CHICO) intervention incorporates a clinician-focused algorithm (STARWAVe) to predict future hospitalisation risk, elicitation of carer concerns, and a carer-focused personalised leaflet recording treatment decisions and safety-netting information. Aim To examine the implementation of the CHICO intervention by primary care clinicians. Design and setting A qualitative study with primary care clinicians in England taking part in the CHICO randomised controlled trial. Method Interviews explored the CHICO intervention’s acceptability and use. Clinicians from a range of practices with high and low antibiotic dispensing rates were recruited. Normalisation process theory underpinned data collection and thematic analysis. Results Most clinicians liked the intervention because it was quick and easy to use, it helped elicit carer concerns, and reassured clinicians and carers of the appropriateness of treatment decisions. However, clinicians used it as a supportive aid for treatment decisions rather than as a tool for behaviour change. The accompanying advice leaflet helped explain treatment decisions and support self-care. The intervention did not always align with clinicians’ usual processes, which could affect use. Increased familiarisation with the algorithm led to reduced intervention use, which was further reduced during the COVID-19 pandemic as a result of changes to practice and remote consultations. Conclusion Clinicians found the CHICO intervention useful to support decision making around antibiotic prescribing and it helped discussions with carers about concerns and treatment decisions. The intervention may need to be adapted to align more with clinicians’ consultation flow and remote consultations.

BACKGROUND:Respiratory tract infections are readily transmitted in care homes. Airborne transmission of pathogens causing respiratory tract illness is largely unmitigated. Portable high-efficiency-particulate-air (HEPA) filtration units capture microbial particles from the air, but it is unclear whether this is sufficient to reduce infections in care home residents. The Air Filtration to prevent symptomatic winter Respiratory Infections (including COVID-19) in care homes (AFRI-c) randomized controlled trial will determine whether using HEPA filtration units reduces respiratory infection episodes in care home residents. METHODS:AFRI-c is a cluster randomized controlled trial that will be delivered in residential care homes for older people in England. Ninety-one care homes will be randomised to take part for one winter period. The intervention care homes will receive HEPA filtration units for use in communal areas and private bedrooms. Normal infection control measures will continue in all care homes. Anonymised daily data on symptoms will be collected for up to 30 residents. Ten to 12 of these residents will be invited to consent to a primary care medical notes review and (in intervention homes) to having an air filter switched on in their private room. The primary outcome will be number of symptomatic winter respiratory infection episodes. Secondary outcomes include specific clinical measures of infection, number of falls / near falls, number of laboratory confirmed infections, hospitalisations, staff sickness and cost-effectiveness. A mixed methods process evaluation will assess intervention acceptability and implementation. DISCUSSION:The results of AFRI-c will provide vital information about whether portable HEPA filtration units reduce symptomatic winter respiratory infections in older care home residents. Findings about effectiveness, fidelity, acceptability and cost-effectiveness will support stakeholders to determine the use of HEPA filtration units as part of infection control policies.

Background Clinical uncertainty in primary care regarding the prognosis of children with respiratory tract infections contributes to the unnecessary use of antibiotics. Improved identification of children at low risk of future hospitalisation might reduce clinical uncertainty. A National Institute for Health and Care Research-funded 5-year programme (RP-PG-0608-10018) was used to develop and feasibility test an intervention. Objectives The aim of the children with acute cough randomised controlled trial was to reduce antibiotic prescribing among children presenting with acute cough and respiratory tract infection without increasing hospital admission. Design An efficient, pragmatic open-label, two-arm trial (with embedded qualitative and health economic analyses) using practice-level randomisation using routinely collected data as the primary outcome. Setting General practitioner practices in England. Participants General practitioner practices using the Egton Medical Information Systems ® patient-record system for children aged 0–9 years presenting with a cough or upper respiratory tract infection. Recruited by Clinical Research Networks and Clinical Commissioning Groups. Intervention Comprised: (1) elicitation of parental concerns during consultation; (2) a clinician-focused prognostic algorithm to identify children with acute cough and respiratory tract infection at low, average or elevated risk of hospitalisation in the next 30 days accompanied by prescribing guidance, (3) provision of a printout for carers including safety-netting advice. Main outcome measures Co-primaries using the practice list-size for children aged 0–9 years as the denominator: rate of dispensed amoxicillin and macrolide items at each practice (superiority comparison) from NHS Business Services Authority ePACT2 and rate of hospital admission for respiratory tract infection (non-inferiority comparison) from Clinical Commissioning Groups, both routinely collected over 12 months. Results Of the 310 practices required, 294 (95%) were recruited (144 intervention and 150 controls) with 336,496 registered 0–9-year-olds (5% of all 0–9-year-old children in England) from 47 Clinical Commissioning Groups. Included practices were slightly larger than those not included, had slightly lower baseline dispensing rates and were located in more deprived areas (reflecting the distribution for practice postcodes nationally). Twelve practices (4%) subsequently withdrew (six related to the pandemic). The median number of times the intervention was used was 70 per practice (by a median of 9 clinicians) over 12 months. There was no evidence that the antibiotic dispensing rate in the intervention practices [0.155 (95% confidence interval 0.135 to 0.179)] differed to controls [0.154 (95% confidence interval 0.130 to 0.182), relative risk= 1.011 (95% confidence interval 0.992 to 1.029); p = 0.253]. There was, overall, a reduction in dispensing levels and intervention usage during the pandemic. The rate of hospitalisation for respiratory tract infection in the intervention practices [0.019 (95% confidence interval 0.014 to 0.026)] compared to the controls [0.021 (95% confidence interval 0.014 to 0.029)] was non-inferior [relative risk = 0.952 (95% confidence interval 0.905 to 1.003)]. The qualitative evaluation found the clinicians liked the intervention, used it as a supportive aid, especially with borderline cases but that it, did not always integrate well within the consultation flow and was used less over time. The economic evaluation found no evidence of a difference in mean National Health Service costs between arms; mean difference −£1999 (95% confidence interval −£6627 to 2630). Conclusions The intervention was feasible and subjectively useful to practitioners, with no evidence of harm in terms of hospitalisations, but did not impact on antibiotic prescribing rates. Future work and limitations Although the intervention does not appear to change prescribing behaviour, elements of the approach may be used in the design of future interventions. Trial registration This trial is registered as ISRCTN11405239 (date assigned 20 April 2018) at www.controlled-trials.com (accessed 5 September 2022). Version 4.0 of the protocol is available at: https://www.journalslibrary.nihr.ac.uk/ (accessed 5 September 2022). Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (NIHR award ref: 16/31/98) programme and is published in full in Health Technology Assessment ; Vol. 27, No. 32. See the NIHR Funding and Awards website for further award information.

Objectives This study aimed to understand the role of surgical Trainee Research Collaboratives (TRCs) in conducting randomised controlled trials and identify strategies to enhance trainee engagement in trials.Design This is a mixed methods study. We used observation of TRC meetings, semi-structured interviews and an online survey to explore trainees’ motivations for engagement in trials and TRCs, including barriers and facilitators. Interviews were analysed thematically, alongside observation field notes. Survey responses were analysed using descriptive statistics. Strategies to enhance TRCs were developed at a workshop by 13 trial methodologists, surgical trainees, consultants and research nurses.Setting This study was conducted within a secondary care setting in the UK.Participants The survey was sent to registered UK surgical trainees. TRC members and linked stakeholders across surgical specialties and UK regions were purposefully sampled for interviews.Results We observed 5 TRC meetings, conducted 32 semi-structured interviews and analysed 73 survey responses. TRCs can mobilise trainees thus gaining wider access to patients. Trainees engaged with TRCs to improve patient care, surgical evidence and to help progress their careers. Trainees valued the TRC infrastructure, research expertise and mentoring. Challenges for trainees included clinical and other priorities, limited time and confidence, and recognition, especially by authorship. Key TRC strategies were consultant support, initial simple rapid studies, transparency of involvement and recognition for trainees (including authorship policies) and working with Clinical Trials Units and research nurses. A 6 min digital story on YouTube disseminated these strategies.Conclusion Trainee surgeons are mostly motivated to engage with trials and TRCs. Trainee engagement in TRCs can be enhanced through building relationships with key stakeholders, maximising multi-disciplinary working and offering training and career development opportunities.

Background Core outcome sets (COSs) are important and necessary as they help standardize reporting in research studies. Cranioplasty following traumatic brain injury (TBI) or stroke is becoming increasingly common, leading to an ever-growing clinical and research interest, especially regarding the optimal material, cost-effectiveness, and timing of cranioplasty concerning neurological recovery and complications. Consequently, heterogeneous reporting of outcomes from such diverse studies has led to limited meta-analysis ability and an ongoing risk of outcome reporting bias. This study aims to define a standardized COS for reporting in all future TBI and stroke cranioplasty studies. Objective This study has four aims: (1) undertake a systematic review to collate the most current outcome measures used within the cranioplasty literature; (2) undertake a qualitative study to understand better the views of clinicians, patients' relatives, and allied health professionals regarding clinical outcomes following cranioplasty; (3) undertake a Delphi survey as part of the process of gaining consensus for the COS; and (4) finalize consensus through a consensus meeting resulting in the COS. Methods An international steering committee has been formed to guide the development of the COS. In addition, recommendations from other clinical initiatives such as COMET (Core Outcomes and Effectiveness Trials) and OMERACT (Outcome Measures in Rheumatology) have been adhered to. Phase 1 is data collection through a systematic review and qualitative study. Phase 2 is the COS development through a Delphi survey and consensus meetings with consensus definitions decided and agreed upon before the Delphi survey begins to avoid bias. Results Phase 1 started at the end of 2019, following ethical approval in December 2019, and the project completion date is planned for the end of 2022 or beginning of 2023. Conclusions This study should result in a consensus on a COS for cranioplasty, following TBI or stroke, to help standardize outcome reporting for future studies, which can be applied to future research and clinical services, help align future studies, build an increased understanding of cranioplasty and its impact on a patient’s function and recovery, and help standardize the evidence base. International Registered Report Identifier (IRRID) DERR1-10.2196/37442

Abstract Objective To assess whether an easy-to-use multifaceted intervention for children presenting to primary care with respiratory tract infections would reduce antibiotic dispensing, without increasing hospital admissions for respiratory tract infection. Design Two arm randomised controlled trial clustered by general practice, using routine outcome data, with qualitative and economic evaluations. Setting English primary care practices using the EMIS electronic medical record system. Participants Children aged 0-9 years presenting with respiratory tract infection at 294 general practices, before and during the covid-19 pandemic. Intervention Elicitation of parental concerns during consultation; a clinician focused prognostic algorithm to identify children at very low, normal, or elevated 30 day risk of hospital admission accompanied by antibiotic prescribing guidance; and a leaflet for carers including safety netting advice. Main outcome measures Rate of dispensed amoxicillin and macrolide antibiotics (superiority comparison) and hospital admissions for respiratory tract infection (non-inferiority comparison) for children aged 0-9 years over 12 months (same age practice list size as denominator). Results Of 310 practices needed, 294 (95%) were randomised (144 intervention and 150 controls) representing 5% of all registered 0-9 year olds in England. Of these, 12 (4%) subsequently withdrew (six owing to the pandemic). Median intervention use per practice was 70 (by a median of 9 clinicians). No evidence was found that antibiotic dispensing differed between intervention practices (155 (95% confidence interval 138 to 174) items/year/1000 children) and control practices (157 (140 to 176) items/year/1000 children) (rate ratio 1.011, 95% confidence interval 0.992 to 1.029; P=0.25). Pre-specified subgroup analyses suggested reduced dispensing in intervention practices with fewer prescribing nurses, in single site (compared with multisite) practices, and in practices located in areas of lower socioeconomic deprivation, which may warrant future investigation. Pre-specified sensitivity analysis suggested reduced dispensing among older children in the intervention arm (P=0.03). A post hoc sensitivity analysis suggested less dispensing in intervention practices before the pandemic (rate ratio 0.967, 0.946 to 0.989; P=0.003). The rate of hospital admission for respiratory tract infections in the intervention practices (13 (95% confidence interval 10 to 18) admissions/1000 children) was non-inferior compared with control practices (15 (12 to 20) admissions/1000 children) (rate ratio 0.952, 0.905 to 1.003). Conclusions This multifaceted antibiotic stewardship intervention for children with respiratory tract infections did not reduce overall antibiotic dispensing or increase respiratory tract infection related hospital admissions. Evidence suggested that in some subgroups and situations (for example, under non-pandemic conditions) the intervention slightly reduced prescribing rates but not in a clinically relevant way. Trial registration ISRCTN11405239ISRCTN registry ISRCTN11405239

Introduction Cranioplasty is a widely practised neurosurgical procedure aimed at reconstructing a skull defect, but its impact on a patient’s rehabilitation following a traumatic brain injury (TBI) or stroke could be better understood. In addition, there are many issues that a TBI patient or the patient who had a stroke and their families may have to adapt to. Insight into some of the potential social barriers, including issues related to social engagement and cosmetic considerations, would be beneficial. Currently, little is known about how this procedure impacts a patient’s recovery, the patient’s perceptions of rehabilitation precranioplasty and postcranioplasty and the broader issues of cosmesis and social reintegration. This study hopes to understand some of these issues and therefore help inform clinicians of some of the difficulties and perceptions that patients and their relatives may have. Methods and analysis A mixed-methods study. Data will be collected through focus groups with healthcare professionals (HCPs) and semi-structured interviews with patients and their relatives, field notes, a researcher diary and a patient questionnaire. Different perspectives will be brought together through method triangulation. Patient and relative data will be analysed using interpretive phenomenological analysis, and HCPs data will be analysed thematically using deductive and inductive coding. Ethics and dissemination Ethical approval has been obtained from the Wales REC 7 ethics committee (Rec ref: 19/WA/0315). There is limited literature regarding a patient’s perception of the cranioplasty process, the potential impact on rehabilitation and how this may impact their reintegration into the community. The results of this study will be presented at national brain injury conferences and published in peer-reviewed, national and international journals.

Objectives Conducting randomised controlled trials (RCTs) in primary care is challenging; recruiting patients during time-limited or remote consultations can increase selection bias and physical access to patients' notes is costly and time-consuming. We investigated barriers and facilitators to running a more efficient design. Design An RCT aiming to reduce antibiotic prescribing among children presenting with acute cough and a respiratory tract infection (RTI) with a clinician-focused intervention, embedded at the practice level. By using aggregate level, routinely collected data for the coprimary outcomes, we removed the need to recruit individual participants. Setting Primary care. Participants Baseline data from general practitioner practices and interviews with individuals from Clinical Research Networks (CRNs) in England who helped recruit practices and Clinical Commission Groups (CCGs) who collected outcome data. Intervention The intervention included: (1) explicit elicitation of parental concerns, (2) a prognostic algorithm to identify children at low risk of hospitalisation and (3) provision of a printout for carers including safety-netting advice. Coprimary outcomes For 0-9 years old-(1) Dispensing data for amoxicillin and macrolide antibiotics and (2) hospital admission rate for RTI. Results We recruited 294 of the intended 310 practices (95%) representing 336 496 registered 0-9 years old (5% of all 0-9 years old children). Included practices were slightly larger, had slightly lower baseline prescribing rates and were located in more deprived areas reflecting the national distribution. Engagement with CCGs and their understanding of their role in this research was variable. Engagement with CRNs and installation of the intervention was straight-forward although the impact of updates to practice IT systems and lack of familiarity required extended support in some practices. Data on the coprimary outcomes were almost 100%. Conclusions The infrastructure for trials at the practice level using routinely collected data for primary outcomes is viable in England and should be promoted for primary care research where appropriate.

BACKGROUND Core Outcome sets (COS) are important and necessary as they help standardize reporting in research studies. Cranioplasty following traumatic brain injury or stroke is becoming increasingly common leading to an ever growing clinical and research interest especially regarding the optimal material, cost-effectiveness, and timing of cranioplasty concerning neurological recovery and complications. Consequently, heterogeneous reporting of outcomes from such diverse studies has led to a limited meta-analysis ability, with the ongoing risk of outcome reporting bias. OBJECTIVE To define a standardized COS for reporting in all future TBI and stroke cranioplasty studies. METHODS An international steering committee has been formed to guide the development of the COS. In addition, recommendations from other clinical initiatives such as COMET (Core Outcomes and Effectiveness Trials) and OMERACT (Outcome Measures in Rheumatology) have been adhered to. The first phase of the project is data-collection through a systematic review and qualitative study. The second phase will be the COS-formation through a Delphi survey and consensus meeting. A definition of consensus will be decided and agreed upon before the Delphi survey begins to avoid bias, which is planned for the end of 2021. RESULTS The development of a cranioplasty COS that can be applied in future research, helping to align future studies, building an increased understanding of cranioplasty and its impact on a patients function and recovery. CONCLUSIONS This study should result in consensus on a COS for cranioplasty following TBI or stroke. CLINICALTRIAL The study has been registered on the Core Outcome Measures in Effectiveness Trials (COMET) database for COS development.

Background Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure following mastectomy. IBBR techniques are evolving rapidly, with mesh-assisted subpectoral reconstruction becoming the standard of care and more recently, prepectoral techniques being introduced. These muscle-sparing techniques may reduce postoperative pain, avoid implant animation and improve cosmetic outcomes and have been widely adopted into practice. Although small observational studies have failed to demonstrate any differences in the clinical or patient-reported outcomes of prepectoral or subpectoral reconstruction, high-quality comparative evidence of clinical or cost-effectiveness is lacking. A well-designed, adequately powered randomised controlled trial (RCT) is needed to compare the techniques, but breast reconstruction RCTs are challenging. We, therefore, aim to undertake an external pilot RCT (Best-BRA) with an embedded QuinteT Recruitment Intervention (QRI) to determine the feasibility of undertaking a trial comparing prepectoral and subpectoral techniques. Methods and analysis Best-BRA is a pragmatic, two-arm, external pilot RCT with an embedded QRI and economic scoping for resource use. Women who require a mastectomy for either breast cancer or risk reduction, elect to have an IBBR and are considered suitable for both prepectoral and subpectoral reconstruction will be recruited and randomised 1:1 between the techniques. The QRI will be implemented in two phases: phase 1, in which sources of recruitment difficulties are rapidly investigated to inform the delivery in phase 2 of tailored interventions to optimise recruitment of patients. Primary outcomes will be (1) recruitment of patients, (2) adherence to trial allocation and (3) outcome completion rates. Outcomes will be reviewed at 12 months to determine the feasibility of a definitive trial. Ethics and dissemination The study has been approved by the National Health Service (NHS) Wales REC 6 (20/WA/0338). Findings will be presented at conferences and in peer-reviewed journals. Trial registration number ISRCTN10081873.

Introduction Respiratory tract infections (RTIs) in children are common and present major resource implications for primary care. Unnecessary use of antibiotics is associated with the development and proliferation of antimicrobial resistance. In 2016, the National Institute for Health Research (NIHR)-funded ‘TARGET’ programme developed a prognostic algorithm to identify children with acute cough and RTI at very low risk of 30-day hospitalisation and unlikely to need antibiotics. The intervention includes: (1) explicit elicitation of parental concerns, (2) the results of the prognostic algorithm accompanied by prescribing guidance and (3) provision of a printout for carers including safety netting advice. The CHIldren’s COugh feasibility study suggested differential recruitment of healthier patients in control practices. This phase III ‘efficiently designed’ trial uses routinely collected data at the practice level, thus avoiding individual patient consent. The aim is to assess whether embedding a multifaceted intervention into general practitioner (GP) practice Information Technology (IT) systems will result in reductions of antibiotic prescribing without impacting on hospital attendance for RTI.Methods and analysis The coprimary outcomes are (1) practice rate of dispensed amoxicillin and macrolide antibiotics, (2) hospital admission rate for RTI using routinely collected data by Clinical Commissioning Groups (CCGs). Data will be collected for children aged 0–9 years registered at 310 practices (155 intervention, 155 usual care) over a 12-month period. Recruitment and randomisation of practices (using the Egton Medical Information Systems web data management system) is conducted via each CCG stratified for children registered and baseline dispensing rates of each practice. Secondary outcomes will explore intervention effect modifiers. Qualitative interviews will explore intervention usage. The economic evaluation will be limited to a between-arm comparison in a cost–consequence analysis.Ethics and dissemination Research ethics approval was given by London-Camden and Kings Cross Research Ethics Committee (ref:18/LO/0345). This manuscript refers to protocol V.4.0. Results will be disseminated through peer-reviewed journals and international conferences.Trial registration number ISRCTN11405239.

Background While patient and public involvement (PPI) in clinical trials is beneficial and mandated by some funders, formal guidance on how to implement PPI is limited and challenges have been reported. We aimed to investigate how PPI is approached within a UK Clinical Trials Unit (CTU)’s portfolio of randomised controlled trials, perceived barriers to/facilitators of its successful implementation, and perspectives on the CTU’s role in PPI. Methods A mixed-methods study design, involving (1) an online survey of 26 trial managers (TMs) and (2) Interviews with Trial Management Group members and public contributors from 8 case-study trials. Quantitative survey data were summarised using descriptive statistics and interview transcripts analysed thematically. Two public contributors advised throughout and are co-authors. Results (1) 21 TMs completed the survey; (2) 19 in-depth interviews were conducted with public contributors ( n =8), TMs ( n =5), chief investigators ( n =3), PPI coordinators ( n =2) and a researcher. 15/21 TMs surveyed reported that a public contributor was on the trial team, and 5 used another PPI method. 12/21 TMs reported that public contributors were paid (range £10–50/h). 5 TMs reported that training was provided for public contributors and few staff members had received any formal PPI training. The most commonly reported tasks undertaken by public contributors were the review of participant-facing materials/study documents and advising on recruitment/retention strategies. Public contributors wanted and valued feedback on changes made due to their input, but it was not always provided. Barriers to successful PPI included recruitment challenges, group dynamics, maintaining professional boundaries, negative attitudes to PPI amongst some researchers, a lack of continuity of trial staff, and the academic environment. Successful PPI required early and explicit planning, sharing of power and ownership of the trial with public contributors, building and maintaining relationships, and joint understanding and clarity about expectations/roles. CTUs have an important role to play in supporting recruitment, signposting and coordinating PPI. Conclusions While highly valuable, PPI in trials is currently variable. PPI representatives are recruited informally, may not be provided with any training and are paid inconsistently across trials. Study findings can help optimise PPI in trials and ensure researchers and public contributors are adequately supported.

BACKGROUND:Parents commonly ask about food allergy tests, to find a cause for their child's eczema, yet the value of routine testing is uncertain.OBJECTIVE:To determine whether a clinical trial comparing test-guided dietary advice versus usual care, for the management of eczema, is feasible.METHODS:Children (>3 months and <5 years) with mild-to-severe eczema, recruited via primary care, were individually randomized (1:1) to intervention or usual care. Intervention participants underwent structured allergy history and skin prick tests (SPT) with dietary advice for cow's milk, hen's egg, wheat, peanut, cashew and codfish. All participants were followed up for 24 weeks. A sample of doctors and parents was interviewed. Registration ISRCTN15397185.RESULTS:From 1059 invitation letters sent to carers of potentially eligible children, 84 were randomized (42 per group) with mean age of 32.4 months (SD 13.9) and POEM of 8.7 (4.8). Of the 42, 6 (14%) intervention participants were advised to exclude one or more foods, most commonly egg, peanut or milk. By participant, 1/6 had an oral food challenge (negative); 3/6 were told to exclude until review in allergy clinic; and 6/6 advised a home dietary trial (exclusion and reintroduction of food over 4-6 weeks) - with 1/6 partially completing it. Participant retention (four withdrawals) and data completeness (74%-100%) were acceptable and contamination low (two usual care participants had allergy tests). There were three minor SPT-related adverse events. During follow-up, 12 intervention and 8 usual care participants had minor, unrelated adverse events plus one unrelated hospital admission.CONCLUSIONS:It is possible to recruit, randomize and retain children with eczema from primary care into a trial of food allergy screening and to collect the outcomes of interest. Changes to recruitment and inclusion criteria are needed in a definitive trial, to ensure inclusion of younger children from more diverse backgrounds.

Aims To inform and guide patient-centred care for men with lower urinary tract symptoms (LUTS), by providing in-depth qualitative evidence regarding men's perspectives on treatment decision-making for LUTS. Methods An interview study of men recruited from 26 English urology departments. Purposive sampling captured surgical/nonsurgical treatment decisions, and diversity in demographics and symptom burden, in men who had urodynamics and those who did not. After diagnostic assessments, men were interviewed either pre-treatment or after LUTS surgery. Thematic analysis was conducted. Participants' descriptions of how LUTS treatment decisions were made were categorised as patient-led, doctor-led, or shared. Results A total of 41 men participated (25 pre-treatment, 16 post-surgery), ages 52-89. Twenty out of 41 described the treatment decision as shared with their consultant, 14 as doctor-led, and seven as patient-led. There was no obvious association between treatment decision-making style and patients' satisfaction with either clinicians' role in their decision or their treatment decision. Incomplete or rushed discussions and misperceptions of LUTS and its treatment were reported, indicating a risk of suboptimal decision-making support by clinicians. As well as clinician opinion, men's treatment decision-making was influenced by the results of urological assessments, comparing current symptoms with possible side-effects of surgery, and others' experiences and opinions. Conclusions Men with LUTS report and prefer different kinds of decision-making support from their clinicians, who must tailor their input to patients' preferences and needs. Patients' treatment decision-making involves multiple factors and can be challenging, and areas of inadequate clinician support were identified. Recommendations for patient-centred consultations about LUTS treatment are presented.

Parents of children with eczema often pursue dietary restrictions as a way of managing eczema and seek allergy testing to guide dietary management. There is a lack of evidence to support this approach and uncertainties about the design and viability of a clinical trial. The aim of TEST is to determine the feasibility of an RCT comparing food allergy testing and advice versus usual care, for the management of eczema in children. Children 3 months-5 years with eczema were recruited via GP surgeries and randomised to intervention or usual care. Intervention participants underwent structured allergy history and skin prick tests (SPTs) for cow’s milk, hen’s egg, wheat, peanut, cashew and codfish; and based on the findings, advised to include or exclude one or more foods from their diet. All participants are followed-up for 24-weeks with four weekly questionnaires and an end-of-study skin assessment. GPs and parents of child participating in the TEST are purposively sampled to take part in a nested qualitative study. Trial protocol https://doi.org/10.1136/bmjopen-2018-028428. Trial registration: ISRCTN15397185. 17/47 GP surgeries who expressed an interest sent 1053 invitation letters. 141/206 replies were potentially eligible, with 84 children randomised (mean age 33 months, range 8 to 58 months). 16/42 intervention participants had no parent-reported symptoms of food allergy and normal SPTs; and 26/42 had “positive” tests to one or more foods (9 equivocal or positive SPTs: 4 egg, 3 peanut, 1 milk, 1 cashew). 6 participants were advised 8 home dietary trials of inclusion/exclusion and 1 underwent oral food challenge. Early findings from semi-structured interviews suggest food allergy testing is acceptable and support a definitive trial. Follow-up will finish in August 2019 and information on participant retention, adherence, data completeness and feasibility of follow-on trial will be presented.