Sleep disturbance is a common issue among patients with head and neck cancer (HNC); it may exacerbate symptom burden and reduce quality of life. However, previous evidence on sleep disturbance trends and predictors is limited; many studies have been small and/or cross-sectional. Therefore, using data from a large, prospective, nationwide cohort, we investigated clinically important sleep disturbance during the first year following diagnosis and the factors associated with it. Head and Neck 5000 (HN5000) recruited HNC patients newly diagnosed in the UK during 2011–2014, with longitudinal follow-up at 4 months and 12 months post-recruitment. Sociodemographic and clinical data were collected via questionnaires and electronic medical records. Patients completed the EORTC QLQ-C30 questionnaire at baseline (pre-treatment) and follow-up, from which sleep disturbance scores (ranging 0–100) were derived. Following past work, clinically important sleep disturbance was defined as a score of 50 or higher. Multivariable mixed-effects logistic regression was used to investigate time trends and identify associated clinical, sociodemographic and lifestyle factors. At baseline, 861 of 2,867 (30.0

BACKGROUND:Children with speech sound disorder (SSD) are at risk of long-term adverse consequences if appropriate intervention is not provided in a timely way. Although there are interventions of proven efficacy, these are often not implemented with good fidelity in clinical practice. Children with SSD in the United Kingdom are commonly managed in care pathways within NHS and independent speech and language therapy services. It is not known which care pathways are most effective because there is currently no systematic recording or analysis of intervention outcomes for children with SSD. AIMS:The objective of the MISLToe-SSD study is to develop an evidence-based protocol for collecting routine data on a large-scale so that UK SSD care pathways can be evaluated for clinical- and cost-effectiveness. The development of the core outcome set (COS) is reported here. METHODS AND PROCEDURES:Following the Core Outcome Measures in Effectiveness Trials methodology, a modified Delphi process was used to reach a consensus on a COS for SSD interventions. The Delphi process comprised two online survey rounds and one online meeting. Anonymity between panel members was maintained during the online survey rounds. Round one required a consensus of ≥50%, rising to ≥75% in round two. OUTCOMES AND RESULTS:A group of 66 UK speech and language therapists identified as experts in SSD by their peers were recruited through specialist clinical and research networks. A long list of 30 outcome statements was reduced by consensus to a final list of seven outcomes with associated measurement instruments. Increased speech intelligibility was agreed as the primary outcome by 100% of panel members. Six secondary outcomes were identified. CONCLUSIONS AND IMPLICATIONS:The final COS can be used in future research to evaluate care pathways and intervention effectiveness for children with SSD. Furthermore, it provides a basis for measuring outcomes in future intervention trials for SSD. WHAT THIS PAPER ADDS:What is already known on this subject Speech and language therapy services in the United Kingdom are ideally placed to contribute to large-scale evaluations of services provided for children with speech sound disorder (SSD) due to the computerised routine collection of data related to client management and interventions. However, these routine data cannot currently be used to evaluate the effectiveness or efficiency of interventions for children with different subtypes of SSD due to a lack of uniformity in data collection. There are no agreed and validated outcomes, outcome measures, diagnostic protocols or agreed labels and definitions for the evidence-based interventions that can be used by services across the United Kingdom. What this study adds to existing knowledge Building on information from an umbrella review and practitioner workshops, a modified Delphi process with 66 SSD expert speech and language therapists from across the United Kingdom, was utilised to develop a core outcome set (COS) and a minimum dataset of common data elements. What are the potential or actual clinical implications of this study? The COS and minimum dataset can be used by speech and language therapy services to collect routine data in a way that can contribute to large-scale evaluations of the effectiveness and efficiency of interventions for children with SSD.

Introduction The quality of relationships between speech and language therapists (SLTs) and clients, in this case, children with speech sound disorder (SSD) of unknown origin, is a crucial factor for successful intervention. These relationships are affected by how services are configured and what SLTs are asking of the children. The public and patients' views are therefore vital in the evaluation or redesign of services. The aim of the present work was, through public and patient involvement and engagement, to gain insight into experiences of young children who had received intervention for SSD.Methods A total of seven children (seen individually) aged 4- to 7-years-old with SSD took part in four activities. The activities took place in a clinical setting with two qualified SLTs facilitating the interactions, one of whom was previously known to the children. Emotional mapping activities- drawing, using toy figurines, emojis and pictures - facilitated the children in telling us about their experiences of SSD interventions.Results Children drew, pointed and verbalised who, what, where and when they had intervention and how they felt about it. Children selected 'happy' or 'cool' emoji to indicate how they felt during therapy. Children commented on environmental factors, such as being taken out of the classroom to see the SLTs, as a positive thing as 'other children are too noisy', and said that it is 'special time' for them to 'work on my sounds'. They also mentioned that they 'liked' their SLTs and personal factors such as the 'big bag with a flower on it, that is full of toys'.Conclusions Children are able to communicate their experiences of speech and language therapy for SSD through emotional mapping activities.

There is currently no consensus on the most important treatment outcomes in patients with mild cognitive impairment (MCI). As part of developing a core outcome set for MCI, we conducted a pragmatic scoping umbrella review to summarize outcomes reported in previous studies. Six electronic databases were searched from inception to August 2023. Systematic and scoping reviews in English with ≥70% of studies describing at least one quantitative outcome of interventions involving adults with MCI were eligible. Verbatim outcomes were extracted from eligible papers within selected reviews. From 170 papers covering 153 studies from 42 reviews, 143 unique outcomes were identified. Global cognition was the only outcome reported by more than 50% of studies. Two-thirds of outcomes were reported by no more than three studies. Heterogeneous outcome reporting limits evidence synthesis and treatment evaluation. A core outcome set for MCI is warranted to standardize outcome reporting and offer stronger evidence for decision-making.

Core outcome sets (COS) are a set of outcomes which stakeholders agree should be collected and reported as part of a minimum dataset for studies in a clinical population. COS developed collaboratively with patients and other stakeholders encourage researchers to report outcomes which are considered important by affected individuals. COS may reduce heterogeneity of outcome selection allowing for better synthesis across studies (e.g., meta-analysis) and reduce selective reporting of positive outcomes to support more informed healthcare decisions. There is currently no approved COS for patients with mild cognitive impairment (MCI). Therefore, we are collaborating with patient and public contributors to develop a COS for people with MCI. The study will involve three stages: 1) an umbrella review, which will provide outcomes from published studies by retrieving articles from systematic and scoping reviews of interventional studies involving people with MCI; 2) interviews with stakeholders with lived experience of MCI (people living with MCI and their partners/relatives) and relevant professional stakeholders (e.g., health and social care professionals or those from relevant charitable organisations or industry) will identify additional outcomes stakeholders consider important; 3) a “long list” of possible outcomes will be curated from Stage 1 and 2 and a two-round Delphi survey process and consensus meeting(s) will identify the final COS to be recommended. The study is ongoing. The review is at the data extraction stage. From the first 25 studies, the most common outcome measurement instruments reported so far are all related to cognitive functioning: the Mini-Mental State Examination (9/25, 36%), Trail Making Test (6/25, 24%), and Verbal Fluency Test (6/25, 24%). Updated results will be available for the conference. Interviews are anticipated to start in mid-2024 with the COS published in 2025. A COS for people with MCI will identify outcomes of importance for individuals affected by MCI and improve transparent outcome reporting in interventional research to better support patient care.

Objectives Abbreviated breast MRI (abMRI) is being introduced into breast screening practice worldwide. Increased provision of abMRI will require mammogram readers to learn abMRI-interpretation and the implementation of abMRI-reading into clinical practice. The present study explores the acceptability of the implementation of developed reader training, and the barriers and facilitators to training programme participation and subsequently to reading the training programme assessment task of abMRI images in a work/NHS context familiar to the individual participants. Methods Fourteen NHS Breast Screening Programme mammogram readers, who were undertaking abMRI interpretation training, participated in semi-structured interviews. Template analysis using the a priori implementation framework, COM-B (Capability, Opportunity, Motivation, Behaviour) was undertaken. Results The training day was well received. Participants identified that their varying ranges of knowledge and experience (capability) was accounted for. Participation in the research was appreciated by all, but especially those new to reading MRI. Radiographers commented that learning to read and understand the abMRI images was motivational, and this helped drive implementation. It was noted that organisational leadership is needed to fully enable change in practice. COVID-19 was commented on in relation to its impact on image reading. Conclusions The project demonstrates that production of training for reading abMRI images and subsequent implementation of changes to practice needs to be carefully planned. Changes must be led by the needs of staff undertaking the tasks. When this is achieved the engagement in training is positive and the barriers are more readily removed or mitigated for both individuals and organisations. Critical relevance statement AbMRI is part of the solution to reducing waiting times for MRI within the NHS, however, training for reading abMRI images and implementation to practice needs to be carefully planned.

INTRODUCTION:First post-contrAst SubtracTed (FAST) MRI, an abbreviated breast MRI scan, has high sensitivity for sub-centimetre aggressive breast cancer and short acquisition and interpretation times. These attributes promise effective supplemental screening. Until now, FAST MRI research has focused on women above population-risk of breast cancer (high mammographic density or personal history). DYAMOND aims to define the population within the population-risk NHS Breast Screening Programme (NHSBSP) likely to benefit from FAST MRI. The study population is the 40% of screening clients aged 50-52 who have average mammographic density (BI-RADS (Breast Imaging Reporting and Data System) B) on their first screening mammogram. DYAMOND will answer whether sufficient numbers of breast cancers, missed by mammography, can be detected by FAST MRI to justify the inclusion of this group in a future randomised controlled trial. METHODS AND ANALYSIS:Prospective, multicentre, diagnostic yield, single-arm study with an embedded qualitative sub-study: all recruited participants undergo a FAST MRI. An internal pilot will assess the willingness of sites and screening clients to participate in the study. Screening clients aged 50-52, with a clear first NHSBSP mammogram and BI-RADS B mammographic density (by automated measurement) will be invited to participate (recruitment target: 1000). The primary outcome is the number of additional cancers detected by FAST MRI (missed by screening mammography). A Fleming's two-stage design will be used as this allows for early stopping after stage 1, to save participants, funding costs and time continuing to the end of the study if the question can be answered earlier. ETHICS AND DISSEMINATION:The NHSBSP Research and Innovation Development Advisory Committee and the Yorkshire and Humber-Sheffield Research Ethics Committee (23/YH/0268, study ID (IRAS): 330059) approved this research protocol. Participation involves a two-stage informed consent process, enabling screening for eligibility through automated mammographic density measurement. Patients with breast cancer helped shape the study design and co-produced participant-facing documents. They will disseminate the results to the public in a clear and meaningful way. Results will be published with open access in international peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER:ISRCTN74193022.

Background This study aimed to explore the barriers and facilitators of implementing rehabilitation interventions for visual field loss due to stroke. Methods The study was a qualitative exploration using one-to-one interviews coded using template analysis and the COM-B a-priori framework. Participants were five occupational therapists from hospital (n=4) and community (n=1) National Health Service (NHS) stroke care settings in England. The intervention experienced by the participant was a standardized goal-based visual scanning and search training for stroke survivors with visual field loss, delivered by occupational therapists (OTs), supported by information sheets and a dedicated website (HABIT). Results HABIT provides a structured approach for delivering scanning and visual search training. HABIT resources aided participants’ understanding and self-management. HABIT was considered similar to current practice as practiced by study participants and of most value to trainees and newly qualified therapists. However, resources had limited accessibility due to a lack of computer access and difficulty in reading text; modifications were required to make training activity examples more suitable for ward settings. Within ward settings, the delivery of HABIT was highly limited by time constraints; therapists ranked activities linked to safety and early discharge as higher priority. Clinicians noted that stroke survivors' lack of awareness of their visual loss and its impact limited their engagement with the HABIT, making delivery difficult. Conclusion Prioritization of vision rehabilitation in highly pressurized acute settings is a key factor in implementing HABIT. The findings will enable further refinement of HABIT content and delivery to address the barriers identified and improve its suitability in acute hospital settings.

Objective The aim of this study was to understand the needs of young people, aged 16 to 20 years, born with cleft lip and/or palate (CL/P) approaching end of routine care, in the United Kingdom (UK). Design Nominal group technique was used during 2 online focus groups to identify priorities for cleft care at transition to adult care. Focus group discussions were recorded, transcribed, and analyzed using reflexive thematic analysis. Participants Ten young people born with CL/P, 8 aged 18 to 20 years and 2 aged 16 to 17 years were recruited via the UK-based cleft charity, the Cleft Lip and Palate Association (CLAPA). Results Three themes were identified from the analysis: Theme 1—Psychological well-being is not a constant. Theme 2—Asking and listening—the cleft clinic appointment. Theme 3—Approaching end of routine care and re-accessing cleft services. Conclusions Findings suggest that young people have ongoing needs in older adolescence. Psychological well-being, taking control of their own treatment and re-accessing the cleft team were highlighted as particular issues. Whilst further research with a larger and more representative sample is needed, these results support the need for continued access to and provision from the cleft team at this age.

BACKGROUND:Several studies have evaluated physiotherapy treatment and/or post-operative care for chronic lumbar radicular pain (CLRP). The extent, range, and nature of research addressing self-management for CLRP is not clear. This scoping review explores existing research evaluating self-management interventions for CLRP. METHODS:A methodology framework based on Arksey & O'Malley 2005 was followed. DATA SOURCES:Four databases were searched from inception to September 2024. SELECTION CRITERIA:We included studies evaluating self-management interventions for adults with CLRP (with or without a control group) and reporting an outcome relevant to self-management. We excluded studies that did not evaluate a self-management intervention, or did not involve a CLRP population. RESULTS:A total of 7,998 titles and abstracts were screened. Although six full text articles were retained for review, none meet inclusion criteria during full text screening. CONCLUSIONS:This systematic scoping review highlights a lack of research addressing self-management interventions for CLRP.

AIM:As cancer care and outcomes improve, self-management becomes a critical aspect of care. Clinical Nurse Specialists roles empower, educate and support individuals with cancer to manage their health confidently. DESIGN:A systematic review following Joanna Briggs Institute guidance and reported in accordance with the PRISMA statement. METHODS:This qualitative systematic review explored the impact of the Clinical Nurse Specialists role in supporting self-management, confidence and capability in people with cancer. Meta-aggregation was used to synthesise the heterogeneous findings. DATA SOURCES:Five databases (Medline, CINAHL, PsycINFO, EmBase and EmCare) were searched for studies involving individuals with cancer in secondary care settings. RESULTS:Seven studies were included, generating 31 themes synthesised into four categories. All studies highlighted the positive impact of the Clinical Nurse Specialists role on individuals' knowledge, skills and abilities to self-manage. CONCLUSION:Clinical nurse specialists role in supporting self-management for individuals with cancer. Their holistic approach fosters confidence and empowers patients to effectively manage their health. Findings highlight the value of nurse-led follow-up services empowering patients with cancer to manage their condition, improving overall well-being. IMPACT:Cancer care is moving to a chronic care model.The review demonstrates CNS's positive impact on individuals care and how CNS are well placed to support patients in managing their care from a holistic perspective. This review highlights how qualitative research supports the value of the CNS role in an individual's experience and ability to self-manage their care. PUBLIC OR PATIENT CONTRIBUTION:This systematic review did not have any public or patient contribution. RELEVANCE TO CLINICAL PRACTICE:Cancer care is moving to a chronic care, self-management model. Clinical nurse specialists are well placed to innovate interventions that assist people with cancer to self-manage. PROSPERO Registration Number: CRD42024494021.

Objectives Abbreviated breast MRI (abMRI) is being introduced into breast screening practice worldwide. Increased provision of abMRI will require mammogram readers to learn abMRI-interpretation and the implementation of abMRI-reading into clinical practice. The present study explores the acceptability of the implementation of developed reader training, and the barriers and facilitators to training programme participation and subsequently to reading the training programme assessment task of abMRI images in a work/NHS context familiar to the individual participants. Methods Fourteen NHS Breast Screening Programme mammogram readers, who were undertaking abMRI interpretation training, participated in semi-structured interviews. Template analysis using the a priori implementation framework, COM-B (Capability, Opportunity, Motivation, Behaviour) was undertaken. Results The training day was well received. Participants identified that their varying ranges of knowledge and experience (capability) was accounted for. Participation in the research was appreciated by all, but especially those new to reading MRI. Radiographers commented that learning to read and understand the abMRI images was motivational, and this helped drive implementation. It was noted that organisational leadership is needed to fully enable change in practice. COVID-19 was commented on in relation to its impact on image reading. Conclusions The project demonstrates that production of training for reading abMRI images and subsequent implementation of changes to practice needs to be carefully planned. Changes must be led by the needs of staff undertaking the tasks. When this is achieved the engagement in training is positive and the barriers are more readily removed or mitigated for both individuals and organisations. Critical relevance statement AbMRI is part of the solution to reducing waiting times for MRI within the NHS, however, training for reading abMRI images and implementation to practice needs to be carefully planned.

Introduction There is no standardised national guidance on clinical management for people living with mild cognitive impairment (MCI), and therapeutic interventions are limited. Understanding what outcomes are important and meaningful to people living with MCI and developing a core outcome set (COS) for research and clinical practice will improve the impact of clinical research and contribute towards developing effective care pathways for MCI. This study aims to develop a COS for adults living with MCI intended for use in interventional and clinical settings.Methods and analysis The COS will be developed using a five-stage study design: (1) systematic literature search, (2) qualitative interviews, (3) evidence synthesis from stages 1 and 2, (4) two-round Delphi survey and (5) consensus meeting(s). First, we will conduct an umbrella review of existing MCI interventional studies and extract a list of outcomes. Qualitative interviews will be held with key stakeholders including individuals living with MCI, friends and family, and relevant professionals to identify further outcomes considered important. Outcomes from the review and interviews will be synthesised into a ‘long list’ of outcomes for potential inclusion in the COS. Two rounds of Delphi surveys followed by a consensus meeting will be used to reach stakeholder consensus on which outcomes should be included in the final COS.Ethics and dissemination We have received ethical approval from the London—Queen Square Research Ethics Committee (23/PR/1580). Patient and public involvement and engagement are central to developing the COS. The results will be disseminated via conferences, peer-reviewed publications, briefing notes to key agencies, to the public via social media and blog posts and directly to stakeholders who participate in the project.Trial registration number Core Outcome Measures in Effectiveness Trials Initiative 2117; PROSPERO registration: CRD42023452514.

INTRODUCTION:Growing evidence suggests that biological sex influences the incidence, presentation, diagnosis and outcomes of many lung diseases. Understanding these differences is the first step towards precision medicine to improve patient care. METHODS:In this cross-sectional study, idiopathic pulmonary fibrosis (IPF) patients enrolled in a national (UK), multicentre registry were categorised by sex and analysed for differences in demographics, pulmonary function tests, high resolution CT radiological pattern, eligibility/uptake of antifibrotics and survival. RESULTS:Of 7177 cases, 77.8% (n=5587) were male, median age 75 years (IQR 69.5-80.5) for both sexes (p=0.83). Males were more likely to have a history of smoking (males 72.9% vs females 60.5%, p<0.001) and lower baseline median forced vital capacity (FVC) % predicted (males 76.4%, IQR 66.2-86.7 vs females 78.8%, IQR 68.6-89.1, p<0.001). Diabetes (males 22.8% vs females 15.1%) and cardiovascular disease (males 58.9% vs females 47.8%) were statistically more common in males (p<0.001), while gastro-oesophageal reflux disease (males 20% vs females 24.6%) and major depressive illness (males 0.8% vs females 2.5%) were more common in females (p<0.001). Significantly, more females experienced symptoms for >24 months prior to first clinic appointment (females 40.1% vs males 36.6%, p=0.03). While more males in the cohort met eligibility criteria for antifibrotics at baseline (pirfenidone FVC 50%-80% males 54.7% vs females 47.6%, nintedanib FVC 50%-80% males 47.0% vs females 41.5%, p<0.001), a larger proportion chose not to commence antifibrotic treatment (males 47.0% vs females 29.6%, p<0.001). Female sex was associated with longer survival; for females, the 75% Kaplan-Meier survival quartile is 7.6 years (95% CI 5.51 to 9.68 years) versus 4.3 years (95% CI 3.82 to 4.78) for males (p<0.001). Male sex (HR 1.76 (95% CI 1.22 to 2.54), p=0.002), higher age (HR 1.042 (95% CI 1.02 to 1.06), p<0.001), lower baseline FVC % predicted (HR 0.98 (95% CI 0.97 to 0.98), p<0.001) and coexistent lung cancer (HR 9.3 (95% CI 2.86 to 30.24), p<0.001) were all independently associated with worse survival. CONCLUSION:This is the first UK study to use national registry data to systematically evaluate IPF disease characteristics stratifying by biological sex and highlights distinct characteristics between groups. Future clinical trials should explicitly explore sex-specific targeted interventions and analyses to optimise future IPF patient care.