OBJECTIVES:To estimate the cost-effectiveness of immediate septoplasty compared with 6 months of medical management with the option for delayed septoplasty in individuals with nasal obstruction associated with septal deviation. DESIGN:Economic evaluation alongside a multicentre, open label, randomised controlled trial. SETTING:17 otolaryngology clinics in the UK, recruiting from January 2018 to December 2019. PARTICIPANTS:Adults aged≥18 years with symptoms of nasal obstruction associated with septal deviation with at least moderate symptoms of nasal obstruction (score>30 on the Nasal Obstruction and Symptom Evaluation scale). INTERVENTIONS:Participants were randomised to receive either septoplasty within 12 weeks of recruitment or 6 months of medical management (nasal steroid and saline spray) with the option for delayed septoplasty. PRIMARY AND SECONDARY OUTCOME MEASURES:Incremental cost per quality-adjusted life year (QALY) gained at 12 months. A UK National Health Service perspective was adopted, and surgery costs were estimated using a tariff and micro-costing. QALYs were estimated based on responses to the Short Form-36 (SF-36). Seemingly unrelated regression was used to estimate incremental costs and QALYs. A model-based analysis was used to extrapolate costs and effects to 24 months. Sensitivity analyses were used to illustrate uncertainty. RESULTS:In the within-trial analysis, immediate septoplasty was on average more costly (mean difference (95% CI) £1193 (£1018 to £1368)) and more effective (mean difference (95% CI) 0.044 QALYs (0.03 to 0.06)) when compared with 6 months of medical management with the option for deferred septoplasty. Immediate septoplasty had an incremental cost per QALY gained of £27 114 in the base case analysis, which decreased to £16 682 when micro-costing was used to estimate surgery costs. Immediate septoplasty had a 15% and 78% probability of being considered cost-effective at a £20 000 threshold for an additional QALY, respectively. In the model-based analysis, immediate septoplasty remained more costly and more effective than 6 months of medical management with the option for deferred septoplasty but had a 99% probability of being considered cost-effective at a £20 000 threshold for an additional QALY. CONCLUSIONS:Over a 24-month time horizon, immediate septoplasty would be cost-effective in the management of deviated nasal septum. STUDY REGISTRATION:ISRCTN16168569.

Introduction Sepsis is a life-threatening syndrome resulting from a dysregulated immune response to an infection. Patients with sepsis can become critically ill and require advanced organ support in a hospital critical care setting. Antibiotics are lifesaving in sepsis, but overuse is associated with harm and promotes antimicrobial resistance, a rising global challenge making antibiotic treatment less effective. The prevalence of antibiotic use is very high in patients admitted to critical care. Research indicates that shorter courses of antibiotics are as effective as longer durations in the treatment of certain infections, but uncertainty remains for patients with sepsis. The aim of SHORTER is to investigate whether treating critically ill patients with suspected or confirmed sepsis with a fixed 5-day, short course of antibiotics is clinically and cost-effective compared with standard of care.Methods and analysis SHORTER is a pragmatic, multicentre, randomised controlled trial. 2244 adults treated with antibiotics for suspected or confirmed sepsis in a critical care setting will be recruited from 50 UK National Health Service hospitals. Participants will be randomised to either a fixed 5-day index course of antibiotics (intervention) or standard of care duration antibiotics (control). The coprimary outcomes are 28-day mortality (non-inferiority) and antibiotic treatment days (superiority). Secondary outcomes will assess the effect of short-duration antibiotic therapy on 90-day mortality, hospital readmissions, further infection rates and health economic impacts. A process evaluation will be embedded in the trial.Ethics and dissemination Favourable ethical opinion has been received from the Wales Research Ethics Committee 4 (Ref: 23/WA/0197) and Scotland A REC (Ref: 24/SS/0013). Results will be publicly disseminated via Patient Public Involvement and Engagement representatives, charities and media, and to the clinical community via professional societies, peer-reviewed publications and conference presentations.Trial registration number ISRCTN40090372.

Objective To review the literature reporting patient preferences for ambulatory heart rhythm monitoring (AHRM) and what factors affect experience and engagement.Background The prevalence of arrhythmia continues to rise and contributes significantly to outpatient care burden. There is limited understanding of patient experience and compliance with monitoring. As innovative technologies are developed and healthcare strategies move towards surveillance and prevention, understanding this is key.Methods A scoping review was conducted using guidance from the Joanna Briggs Institute and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. The review included studies of adults under investigation or surveillance for arrhythmia with a range of devices (Holter monitor, patch device, event recorder, mobile cardiac telemetry, external and implantable loop recorders, wearables and other implantable cardiac devices) in ambulatory care settings worldwide. The final search was conducted on 3 January 2026 across Medline (PubMed), Embase (Ovid), Web of Science (Clarivate Analytics), Cumulative Index to Nursing and Allied Health Literature (EBSCOhost), PsycINFO (Ovid) and Google Scholar. Quantitative, qualitative, mixed methods, multiple methods and any type of review articles were included.Results 54 studies were eligible for inclusion from the initial search that identified 1320 articles. Two overarching themes emerged from the quantitative and qualitative data: patient factors and device factors affecting experience and engagement. Patient factors included clinical and demographic factors, education and expectations, experience and preferences and impact on daily life and healthcare. Device factors could be common to several devices, for example, skin irritation or device specific, for example, the nature of activation.Conclusion Patient and device factors influence preferences for and experience and engagement with AHRM. While existing literature is incomplete and heterogeneous, it identifies key considerations that should be integrated into the development and testing of novel approaches for arrhythmia surveillance in healthcare contexts.Registration https://doi.org/10.17605/OSF.IO/6K3W8 (Open Science Framework).

Background:Bronchiectasis is a long-term lung condition associated with bronchial dilatation, chronic inflammation and infection. Treatment is often empirical or extrapolated from other lung conditions, for example the use of inhaled therapies licensed for use in asthma or chronic obstructive pulmonary disease. Inhaled therapies, such as corticosteroids or long-acting bronchodilators (long-acting beta agonists or long-acting muscarinic antagonists), are commonly used in bronchiectasis despite scanty evidence on exacerbation reduction. Objective:To assess whether: dual bronchodilators (long-acting beta agonists/long-acting muscarinic antagonists) either as stand-alone therapy or in combination with inhaled corticosteroid are superior to placebo at reducing mean exacerbation rates over 12 months dual bronchodilators (long-acting beta agonists/long-acting muscarinic antagonists) are non-inferior to triple therapy (inhaled corticosteroid/long-acting beta agonists/long-acting muscarinic antagonists) at reducing mean exacerbation rates over 12 months. Design:Pragmatic, multicentre, placebo-controlled, three-arm, double-blinded, prospective, randomised controlled trial incorporating a 12-month internal pilot. Target population:Six hundred adults with bronchiectasis and history of ≥ 2 exacerbations in any 12-month period within the preceding 2 years. Setting:United Kingdom National Health Service secondary care sites. Interventions:Twelve months, one puff daily of either dual therapy [55 μg umeclidinium (long-acting muscarinic antagonists) and 22 μg vilanterol (long-acting beta agonists)], triple therapy [dual therapy plus 92 μg fluticasone furoate (inhaled corticosteroid)] or matched placebo dry powder inhalers, randomised in a 2 : 2 : 1 ratio, respectively. Outcome measures:Primary: number of participants reported bronchiectasis exacerbations requiring treatment with antibiotics during the 12-month treatment period. Primary economic: incremental cost per quality-adjusted life-year gained at 12 months. Results:Recruitment rates did not follow projections due to the COVID-19 pandemic; 85 potentially eligible patients were screened, of whom 33 (39%) were randomised. Of the randomised participants, 30 (91%) completed follow-up at 12 months; 3 participants withdrew [1/14 (7%) dual therapy, 1/12 (8%) triple therapy and 1/7 (14%) placebo]. Five participants discontinued therapy during the trial [1/14 (7%) dual therapy, 2/12 (17%) triple therapy and 2/7 (29%) placebo]. Given the small sample size, the statistical and economic analyses are descriptive and exploratory. Exacerbation data were available for 32/33 (97%) of randomised participants (13 dual therapy, 12 triple therapy and 7 placebo). The median number of exacerbations during the follow-up (the primary outcome) was 1 (interquartile range 0-3) for dual therapy, 2 (1, 2.5) for triple therapy and 3 (2, 3) for placebo. No safety concerns were identified. Complete resource-use and quality-of-life data were available for 30/33 (91%) participants. Conclusions:COVID-19 impacted delivery of the trial, affecting staff capacity, setting up of timelines, and ultimately, recruitment to the pilot. There was good retention and data completeness within the trial randomised participants. The trial is unable to provide evidence on the superiority or cost-effectiveness of dual or triple therapy to placebo at reducing mean exacerbation rates over 12 months or the non-inferiority of dual to triple therapy. Future work and limitations:The main limitation of this work is the small sample size that prevents any firm conclusions to be made. However, the results do suggest that there is a signal of efficacy and that a larger trial is needed to provide valuable clinical evidence. These results underscore the importance of completing a large-scale trial of these therapies to help improve the understanding and best treatment for patients with bronchiectasis. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR127460.

Aims Amalgam is being phased out globally by 2034. Under English NHS provision, amalgam is predominantly used to restore posterior teeth. A broad evaluation of the comparative costs and consequences of using amalgam versus various composite formulations to restore posterior permanent teeth in adults was therefore required to inform a phase-out. Methods Multiple research strands (a large clinician survey, a discrete choice experiment to obtain public values for relevant aspects of direct restorations, and a model-based cost-effectiveness analysis) alongside new data were synthesised. Costs and consequences to patients, funders and clinicians of using amalgam and direct alternatives over varying timeframes under English NHS provision were quantified in a cost-consequence analysis. Results Differences in tooth survival (4 years; 12 years non-discounted), patient valuation (£33), and lifetime cost to patients (£70 direct; £15 indirect), funders (£34) and clinicians (£83) favour amalgam over composite restorations in English NHS care. Conclusions Except for appearance, all other outcomes and costs favoured the use of amalgam over composites for the direct restoration of posterior teeth for all stakeholders. If amalgam is phased-out in the near future without fundamental change, there are significant implications for the most at need in society and the survival of NHS dental services.

This study comparing exacerbations rates for dual bronchodilator therapy, triple therapy and placebo in bronchiectasis cannot provide definitive evidence. However, results suggest signs of of efficacy: a larger trial may provide valuable clinical evidence. https://bit.ly/4fuuHHX.

Smoking is a key contributor to health inequalities, particularly impacting oral health. Periodontal (gum) health is significantly affected by smoking. With their extensive reach, regular and frequent patient contact, and potential teachable moments, dental teams are well placed to support patients to stop smoking. This is currently mainly provided through Very Brief Advice (VBA) interventions and so there is scope to enhance the cessation support offered. A large definitive trial is needed to confirm whether this would lead to improved smoking quit rates, improved oral health, and be good value for money. The ENHANCE-D trial is a multi-centre, pragmatic, definitive, 3-arm, parallel group, individually randomised controlled superiority trial, including an internal pilot, conducted in NHS dental settings. In total, 1215 patients who are current regular smokers will be randomly allocated using a 1:2:2 ratio to the following: (i) VBA; (ii) the offer of a standard course of Nicotine Replacement Therapy (NRT); (iii) or the offer of an e-cigarette starter kit. A subgroup of patients with periodontitis (gum disease) will have additional oral examinations and samples collected. The primary outcome is biochemically verified smoking abstinence at 6 months. A key secondary outcome is the percentage of periodontal sites with probing pocket depths (PPDs) ≥ 5 mm at 6 months in the periodontitis subgroup. Participants will be blinded to the purpose of the trial and not be aware of the treatment packages. Periodontal health outcomes will be recorded by trained and aligned assessors, blinded to intervention arm. Participant recruitment started in July 2022 with an internal pilot progressing to the main trial in May 2023. A qualitative process evaluation will explore participants’ experiences of receiving the study interventions, alongside the views of dental teams, NHS commissioners, service managers, and policymakers. An economic evaluation will include a cost-effectiveness analysis and a cost–benefit analysis. This will be the largest contemporary randomised trial of smoking cessation interventions in dental settings and one of the first to evaluate enhanced interventions. E-cigarettes were included as an intervention due to growing evidence of their effectiveness. They will be compared to VBA and NRT, and oral health outcomes assessed. The multi-centre, pragmatic design of this trial supports the external validity and potential for impacting clinical practice. ISRCTN 13158982. Registered on 10 May 2022. https://www.isrctn.com/ISRCTNISRCTN13158982

Background The indications for septoplasty are practice-based, rather than evidence-based. In addition, internationally accepted guidelines for the management of nasal obstruction associated with nasal septal deviation are lacking. Objective The objective was to determine the clinical effectiveness and cost-effectiveness of septoplasty, with or without turbinate reduction, compared with medical management, in the management of nasal obstruction associated with a deviated nasal septum. Design This was a multicentre randomised controlled trial comparing septoplasty, with or without turbinate reduction, with defined medical management; it incorporated a mixed-methods process evaluation and an economic evaluation. Setting The trial was set in 17 NHS secondary care hospitals in the UK. Participants A total of 378 eligible participants aged > 18 years were recruited. Interventions Participants were randomised on a 1: 1 basis and stratified by baseline severity and gender to either (1) septoplasty, with or without turbinate surgery (n = 188) or (2) medical management with intranasal steroid spray and saline spray (n = 190). Main outcome measures The primary outcome was the Sino-nasal Outcome Test-22 items score at 6 months (patient-reported outcome). The secondary outcomes were as follows: patient-reported outcomes – Nasal Obstruction Symptom Evaluation score at 6 and 12 months, Sino-nasal Outcome Test-22 items subscales at 12 months, Double Ordinal Airway Subjective Scale at 6 and 12 months, the Short Form questionnaire-36 items and costs; objective measurements – peak nasal inspiratory flow and rhinospirometry. The number of adverse events experienced was also recorded. A within-trial economic evaluation from an NHS and Personal Social Services perspective estimated the incremental cost per (1) improvement (of ≥ 9 points) in Sino-nasal Outcome Test-22 items score, (2) adverse event avoided and (3) quality-adjusted life-year gained at 12 months. An economic model estimated the incremental cost per quality-adjusted life-year gained at 24 and 36 months. A mixed-methods process evaluation was undertaken to understand/address recruitment issues and examine the acceptability of trial processes and treatment arms. Results At the 6-month time point, 307 participants provided primary outcome data (septoplasty, n = 152; medical management, n = 155). An intention-to-treat analysis revealed a greater and more sustained improvement in the primary outcome measure in the surgical arm. The 6-month mean Sino-nasal Outcome Test-22 items scores were −20.0 points lower (better) for participants randomised to septoplasty than for those randomised to medical management [the score for the septoplasty arm was 19.9 and the score for the medical management arm was 39.5 (95% confidence interval −23.6 to −16.4; p < 0.0001)]. This was confirmed by sensitivity analyses and through the analysis of secondary outcomes. Outcomes were statistically significantly related to baseline severity, but not to gender or turbinate reduction. In the surgical and medical management arms, 132 and 95 adverse events occurred, respectively; 14 serious adverse events occurred in the surgical arm and nine in the medical management arm. On average, septoplasty was more costly and more effective in improving Sino-nasal Outcome Test-22 items scores and quality-adjusted life-years than medical management, but incurred a larger number of adverse events. Septoplasty had a 15% probability of being considered cost-effective at 12 months at a £20,000 willingness-to-pay threshold for an additional quality-adjusted life-year. This probability increased to 99% and 100% at 24 and 36 months, respectively. Limitations COVID-19 had an impact on participant-facing data collection from March 2020. Conclusions Septoplasty, with or without turbinate reduction, is more effective than medical management with a nasal steroid and saline spray. Baseline severity predicts the degree of improvement in symptoms. Septoplasty has a low probability of cost-effectiveness at 12 months, but may be considered cost-effective at 24 months. Future work should focus on developing a septoplasty patient decision aid. Trial registration This trial is registered as ISRCTN16168569 and EudraCT 2017-000893-12. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/226/07) and is published in full in Health Technology Assessment; Vol. 28, No. 10. See the NIHR Funding and Awards website for further award information.

Abstract Background Condition-specific health-related quality-of-life (HRQoL) instruments can be more responsive and sensitive to specific conditions and diseases than generic HRQoL instruments. This systematic review aims to identify the condition-specific preference-based instruments that have been used with young people and identify how preference values have been obtained for these instruments. This review will inform future researchers about the methods used to elicit utilities for condition-specific HRQoL instruments. Methods A comprehensive search strategy was used to identify condition-specific HRQoL instruments used in young people and the methods used to value these instruments. Published medical and health economic databases were searched from January 1990–March 2022. Articles were deemed eligible for inclusion if a condition-specific preference-based instrument was used in young people (age < 18). Screening, data extraction and quality assessment were conducted independently by at least two reviewers. Results After deduplication, a total of 4273 articles were eligible for title and abstract screening. Of these, 98 articles were eligible for full-text screening. After full-text screening, 18 articles were included in the review. Valuation studies were the most prevalent study design in the review (44%), followed by mapping studies (38%) and then other designs (18%). Among the valuation studies, the choice of HRQoL instrument, preference elicitation method, anchoring method and perspective varied considerably. Conclusion To our knowledge, this review is the first to explore what condition-specific HRQoL instruments have been used in young people. Findings from this review could inform researchers in their choice of methods for measuring and valuing HRQoL. This review illustrates that to date there does not appear to be clear consensus of how to measure and value HRQoL in young people when using condition-specific instruments. The lack of consensus could be influenced by challenges identified in prior research such as limited guidance, ethical issues, and uncertain normative decisions regarding the choice of preference elicitation method. Ordinal methods such as discrete choice experiment and best-worst scaling appear to be preferable for use in this population.

Background:Problems in children's early social and emotional development are likely to have major long-term consequences for the individual and society: maternal emotional well-being is associated with better outcomes. Interventions designed to improve both maternal mental health and the mother-child relationship are thus likely to benefit both maternal health and child development. Objectives:To establish the clinical and cost-effectiveness of the Mellow Babies parenting intervention for women experiencing psychosocial stress and their 6- to 18-month-old babies. Secondary aims included understanding the process of recruitment, retention and engagement in both the trial and the intervention. Design:This was a single-centre randomised controlled trial, employing 1 : 1 randomisation with participants allocated to receive Mellow Babies plus usual care, or usual care only. Setting:Community settings in the Highland Council region of Scotland. Participants:We aimed to recruit 212 mothers to provide evaluable data for 170 participants (90% power to detect an effect size of 0.5 for the primary outcome). Eligible mothers lived within the Highland Council region; were aged ≥ 16 years; had primary caregiving responsibility of a baby aged 6-18 months and scored above threshold for anxiety (≥ 11) and/or depression (≥ 7) on the Hospital Anxiety and Depression Scale. Intervention:Mellow Babies is a 14-week group-based parenting programme specifically designed for mothers with psychosocial difficulties. Sessions run for 5 hours each and include 4-10 participants. Main outcome measures:Maternal Hospital Anxiety and Depression Scale scores at 8 months post randomisation and when the child reaches 30 months. Health economic (service use and quality of life) and child development (language development and mental well-being) outcomes were also examined. Results:Due to the COVID-19 pandemic, the trial did not recruit to target: 106 women were recruited (53 per arm). It was not possible to explore the clinical and cost-effectiveness of Mellow Babies. Baseline, follow-up and process evaluation data were analysed to allow optimal learning from the study. Direct communication (letter) combined with health visitor referral was a better means of recruitment. Despite relatively low sociodemographic disadvantage, there was a high prevalence of mental ill health. Retention to follow-up and within the intervention was good (75% to study end point), and data were well-completed. Quality-of-life ratings increased at 8 months post randomisation, then decreased somewhat at 30 months of age, but remained above baseline. Qualitative interviews highlighted barriers and facilitators of engagement with the intervention groups. There was no observed difference in baseline characteristics or outcomes between participants recruited before and after the pandemic, although the logistical impact on the trial was profound. Limitations:The study was not sufficiently powered to answer the main outcome questions. The occurrence of the COVID-19 pandemic severely hampered the current trial. Conclusions:This trial was not able to answer questions on clinical and cost-effectiveness. Learning from this trial could inform a new re-designed trial including cluster randomisation and based within a larger and more varied population. Future work:There is still a need for a definitive trial of Mellow Babies. It would likely be most fruitful to conduct a cluster randomised trial, with full buy-in from key health service stakeholders and front-line practitioners, to maximise recruitment, engagement and participation. Trial registration:The trial is registered as ISRCTN47575326. Funding:This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 15/126/05) and is published in full in Public Health Research; Vol. 12, No. 17. See the NIHR Funding and Awards website for further award information.

BackgroundThere is limited evidence on what shapes the acceptability of population level dietary and active-travel policies in England. This information would be useful in the decision-making process about which policies should be implemented and how to increase their effectiveness and sustainability. To fill this gap, we explored public and policymakers' views about factors that influence public acceptability of dietary and active-travel policies and how to increase public acceptability for these policies.MethodsWe conducted online, semi-structured interviews with 20 members of the public and 20 policymakers in England. A purposive sampling frame was used to recruit members of the public via a recruitment agency, based on age, sex, socioeconomic status and ethnicity. Policymakers were recruited from existing contacts within our research collaborations and via snowball sampling. We explored different dietary and active-travel policies that varied in their scope and focus. Interviews were transcribed verbatim and analysed using thematic reflexive analysis with both inductive and deductive coding.ResultsWe identified four themes that informed public acceptability of dietary and active-travel policies: (1) perceived policy effectiveness, i.e., policies that included believable mechanisms of action, addressed valued co-benefits and barriers to engage in the behaviour; (2) perceived policy fairness, i.e., policies that provided everyone with an opportunity to benefit (mentioned only by the public), equally considered the needs of various population subgroups and rewarded 'healthy' behaviours rather than only penalising 'unhealthy' behaviours; (3) communication of policies, i.e., policies that were visible and had consistent and positive messages from the media (mentioned only by policymakers) and (4) how to improve policy support, with the main suggestion being an integrated strategy addressing multiple aspects of these behaviours, inclusive policies that consider everyone's needs and use of appropriate channels and messages in policy communication.ConclusionsOur findings highlight that members' of the public and policymakers' support for dietary and active-travel policies can be shaped by the perceived effectiveness, fairness and communication of policies and provide suggestions on how to improve policy support. This information can inform the design of acceptable policies but can also be used to help communicate existing and future policies to maximise their adoption and sustainability.

Introduction Bronchiectasis is a long-term lung condition, with dilated bronchi, chronic inflammation, chronic infection and acute exacerbations. Recurrent exacerbations are associated with poorer clinical outcomes such as increased severity of lung disease, further exacerbations, hospitalisations, reduced quality of life and increased risk of death. Despite an increasing prevalence of bronchiectasis, there is a critical lack of high-quality studies into the disease and no treatments specifically approved for its treatment. This trial aims to establish whether inhaled dual bronchodilators (long acting beta agonist (LABA) and long acting muscarinic antagonist (LAMA)) taken as either a stand-alone therapy or in combination with inhaled corticosteroid (ICS) reduce the number of exacerbations of bronchiectasis requiring treatment with antibiotics during a 12 month treatment period. Methods This is a multicentre, pragmatic, double-blind, randomised controlled trial, incorporating an internal pilot and embedded economic evaluation. 600 adult patients (≥18 years) with CT confirmed bronchiectasis will be recruited and randomised to either inhaled dual therapy (LABA+LAMA), triple therapy (LABA+LAMA+ICS) or matched placebo, in a 2:2:1 ratio (respectively). The primary outcome is the number of protocol defined exacerbations requiring treatment with antibiotics during the 12 month treatment period. Ethics and dissemination Favourable ethical opinion was received from the North East—Newcastle and North Tyneside 2 Research Ethics Committee (reference: 21/NE/0020). Results will be disseminated in peer-reviewed publications, at national and international conferences, in the NIHR Health Technology Assessments journal and to participants and the public (using lay language). Trial registration number ISRCTN15988757.

BACKGROUND:Parkinson's disease (PD) is the second most common neurodegenerative disorder and, according to the Global Burden of Disease estimates in 2015, was the fastest growing neurological disorder globally with respect to associated prevalence, disability, and deaths. Information regarding the awareness, diagnosis, phenotypic characteristics, epidemiology, prevalence, risk factors, treatment, economic impact and lived experiences of people with PD from the African perspective is relatively sparse in contrast to the developed world, and much remains to be learned from, and about, the continent.METHODS:Transforming Parkinson's Care in Africa (TraPCAf) is a multi-faceted, mixed-methods, multi-national research grant. The study design includes multiple sub-studies, combining observational (qualitative and quantitative) approaches for the epidemiological, clinical, risk factor and lived experience components, as appropriate, and interventional methods (clinical trial component). The aim of TraPCAf is to describe and gain a better understanding of the current situation of PD in Africa. The countries included in this National Institute for Health and Care Research (NIHR) Global Health Research Group (Egypt, Ethiopia, Ghana, Kenya, Nigeria, South Africa and Tanzania) represent diverse African geographies and genetic profiles, with differing resources, healthcare systems, health and social protection schemes, and policies. The research team is composed of experts in the field with vast experience in PD, jointly led by a UK-based and Africa-based investigator.DISCUSSION:Despite the increasing prevalence of PD globally, robust data on the disease from Africa are lacking. Existing data point towards the poor awareness of PD and other neurological disorders on the continent and subsequent challenges with stigma, and limited access to affordable services and medication. This multi-site study will be the first of its kind in Africa. The data collected across the proposed sub-studies will provide novel and conclusive insights into the situation of PD. The selected country sites will allow for useful comparisons and make results relevant to other low- and middle-income countries. This grant is timely, as global recognition of PD and the public health challenge it poses builds. The work will contribute to broader initiatives, including the World Health Organization's Intersectoral global action plan on epilepsy and other neurological disorders.TRIAL REGISTRATION:https://doi.org/10.1186/ISRCTN77014546 .

Alzheimer’s disease (AD) and Parkinson’s disease (PD) are the most common neurodegenerative conditions. Information on the preferences of patients, health care professionals and the public on the early detection, diagnosis and treatment of these conditions is limited. Understanding preferences is essential to improve health-related outcomes. Discrete choice experiments (DCEs) are a widely used method to elicit preferences. A previous systematic review identified the attributes that were included in DCEs related to health technologies, although none of the included studies related to neurodegenerative conditions. To identify attributes and their respective levels used in the design of discrete choice experiments that examined preferences for early detection, diagnosis and treatment for AD and PD. Four large databases (Cinahl, Embase, Medline, Scopus, Web of science) were searched between January 2015 and October 2022. Search terms included grouped into sets relating to discrete choice and dementia. The search was limited to peer reviewed studies in English and related to the use of health technology (defined as the application of organised knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems) in the early detection, diagnosis or treatment AD or PD. Studies included people diagnosed with AD or PD, members of the public or clinicians. This review was registered with PROSPERO (registration number: CRD42023365169), adhered to PRISMA guidelines and used a DCE quality assessment tool devised by Mandeville et al. (2014). A total of 196 studies were identified, eight of which were included. Two studies focused on AD and six studies on PD. The average number of attributes included in the DCEs was 4.5 (SD 0.57), the average number of levels per attribute was 3.4 (SD 0.80). The most common attributes used in DCEs were as follows: risk of side effects, cost, device type, oral medicines required, duration of ON time and increase in daily ON time (the period when medication for Parkinson’s is effective is ON time). There was no overlap in attributes within studies reporting on AD. Preference researchers can incorporate the attributes identified into surveys in order to support the development of clinical decision-making frameworks.

Abstract Objective To assess the clinical effectiveness of septoplasty. Design Multicentre, randomised controlled trial. Setting 17 otolaryngology clinics in the UK’s National Health Service. Participants 378 adults (≥18 years, 67% men) newly referred with symptoms of nasal obstruction associated with septal deviation and at least moderate symptoms of nasal obstruction (score >30 on the Nasal Obstruction and Symptom Evaluation (NOSE) scale). Interventions Participants were randomised 1:1 to receive either septoplasty (n=188) or defined medical management (n=190, nasal steroid and saline spray for six months), stratified by baseline symptom severity and sex. Main outcome measures The primary outcome measure was patient reported score on the Sino-Nasal Outcome Test-22 (SNOT-22) at six months, with 9 points defined as the minimal clinically important difference. Secondary outcomes included quality of life and objective nasal airflow measures. Results Mean SNOT-22 scores at six months were 19.9 (95% confidence interval 17.0 to 22.7) in the septoplasty arm (n=152, intention-to-treat population) and 39.5 (36.1 to 42.9) in the medical management arm (n=155); an estimated 20.0 points lower (better) for participants randomised to receive septoplasty (95% confidence interval 16.4 to 23.6, P<0.001, adjusted for baseline continuous SNOT-22 score and the stratification variables sex and baseline NOSE severity categories). Greater improvement in SNOT-22 scores was predicted by higher baseline symptom severity scores. Quality of life outcomes and nasal airflow measures (including peak nasal inspiratory flow and absolute inhalational nasal partitioning ratio) improved more in participants in the septoplasty group. Readmission to hospital with bleeding after septoplasty occurred in seven participants (4% of 174 who had septoplasty), and a further 20 participants (12%) required antibiotics for infections. Conclusions Septoplasty is a more effective intervention than a defined medical management regimen with a nasal steroid and saline spray in adults with nasal obstruction associated with a deviated nasal septum. Trial registration ISRCTN Registry ISRCTN16168569 .

OBJECTIVES:Preference information is increasingly being elicited to support decision-making. Although discrete choice experiments (DCEs) are commonly used, little is known about how respondents' relative experience of a health issue, and its treatment, might impact the results of preference studies. The aim of this study was to explore how preferences differ between groups of individuals with varying levels of experience of a health issue and its treatment, using a weight loss maintenance (WLM) programme as a case study. METHODS:An online DCE survey was provided to four groups, each differing in their level of experience with weight loss and WLM programmes. One group was recruited from a randomised controlled trial of a WLM programme (ISRCTN14657176) and the other three from an online panel. Choice data were analysed using mixed logit models. Relative attribute importance scores and willingness-to-pay (WTP) estimates were estimated to enable comparisons between groups. RESULTS:Preferences differed between the groups across different attributes. The largest differences related to the outcome (weight re-gain) and cost attributes, resulting in WTP estimates that were statistically significantly different. The most experienced group was willing to pay £0.35 (95% CI: £0.28, £0.42) to avoid a percentage point increase in weight re-gain, compared with £0.12 (95% CI: £0.08, £0.16) for the least experienced group. CONCLUSION:This study provides evidence in a public health setting to suggest that preferences differ based on respondent experience of the health issue and its treatment. Health preference researchers should therefore carefully consider the appropriate composition of their study samples.

Introduction: Amalgam use has recently been phased down, and the potential for a phase-out is being investigated. Objectives: The study aimed to identify knowledge of the phase-down and opinions of a potential phase-out of amalgam by UK primary care clinicians and assess their confidence in using different materials in different situations. Methods: An anonymized, prepiloted cross-sectional e-survey was used to assess primary care clinicians' knowledge and opinions of the amalgam phase-down and potential phase-out and their confidence in using amalgam and the alternatives in different situations. In total, 11,902 invitations were distributed through British dentist and therapist associations. Prior hypotheses were tested alongside descriptive statistics. Results: Response rate was 13% (n = 1,513). Knowledge of the amalgam phase-down was low, with just 3% clinicians correctly identifying all patient groups in whom amalgam use should be avoided in the United Kingdom. Postgraduate education on posterior composite placement was high (88%), but a large majority had personal and patient-centered concerns over the suitability of the alternatives and lacked confidence when placing composite in comparison to amalgam in difficult situations (P < 0.0001). Logistic regressions revealed that the best predictors of high confidence in placing mesio-occluso-distal composites and composites in difficult situations were being a private general dentist or being primarily a composite user. Conclusion: Primary care clinicians have major personal and patient-centered concerns regarding the amalgam phase-down (of which they have limited knowledge) and potential phase-out. Many lack confidence in using the alternative, composite, to restore posterior teeth in difficult situations, whereas confidence in using amalgam in similar situations is high. Effective education of clinicians and understanding patients' needs, alongside policy changes, are required to enable a successful amalgam phase-down and potential phase-out. Knowledge Transfer Statement: This study shows that UK primary care clinicians are worried about the phase-down of amalgam for themselves and their patients. Many lack confidence in the alternative, composite, when used in difficult situations, which is in stark contrast to amalgam. Knowledge of the phase-down is limited. There is a need for more effective education of clinicians, an understanding of patients' values, and policy changes to ensure the success of the phase-down and potential phase-out of amalgam.

Abstract Aims Many parents in contact with children’s social care services misuse alcohol however do not meet the threshold for specialist alcohol treatment, and typically do not receive appropriate support for their needs. Brief alcohol interventions have been found to be effective in healthcare settings, however, it is unknown whether the brief intervention structure delivered within health settings would transfer well into children’s social care. This paper aims to examine the characteristics of brief intervention for alcohol misusing parents which social care practitioners consider to be important and acceptable to implement in this sector. Methods We assessed preferences for, and acceptability of, brief alcohol intervention with parents in contact with children’s social care using a discrete choice experiment. We recruited 205 children’s social care practitioners from London and the North East of England. Data were analysed using mixed logit which accounted for repeated responses. Findings Six attributes showed statistically significant coefficients, suggesting that a brief intervention with these attributes would encourage implementation. These were: level of alcohol-related risk targeted; intervention recipient; timing of intervention; duration of sessions; number of sessions and intervention structure. The attribute of most importance identified based on the attribute with the largest coefficient in the conditional logit model was risk level. Conclusions Brief alcohol interventions delivered to parents in social care should focus on the impact upon children and the wider family, they should be a flexible part of on-going casework and should be more intensive and less structured.

Background: Oral mucositis is a debilitating and painful complication of head and neck cancer irradiation that is characterised by inflammation of the mucous membranes, erythema and ulceration. Oral mucositis affects 6000 head and neck cancer patients per year in England and Wales. Current treatments have not proven to be effective. International studies suggest that low-level laser therapy may be an effective treatment. Objectives: To assess the clinical effectiveness and cost-effectiveness of low-level laser therapy in the management of oral mucositis in head and neck cancer irradiation. To identify barriers to and facilitators of implementing low-level laser therapy in routine care. Design: Placebo-controlled, individually randomised, multicentre Phase III superiority trial, with an internal pilot and health economic and qualitative process evaluations. The participants, outcome assessors and therapists were blinded. Setting: Nine NHS head and neck cancer sites in England and Wales. Participants: A total of 87 out of 380 participants were recruited who were aged ≥ 18 years and were undergoing head and neck cancer irradiation with ≥ 60 Gy. Intervention: Random allocation (1 : 1 ratio) to either low-level laser therapy or sham low-level laser therapy three times per week for the duration of irradiation. The diode laser had the following specifications: wavelength 660 nm, power output 75 mW, beam area 1.5 cm2, irradiance 50 mW/cm2, exposure time 60 seconds and fluence 3 J/cm2. There were 20–30 spots per session. Sham low-level laser therapy was delivered in an identical manner. Main outcome measure: The mean Oral Mucositis Weekly Questionnaire-Head and Neck Cancer score at 6 weeks following the start of irradiation. Higher scores indicate a worse outcome. Results: A total of 231 patients were screened and, of these, 87 were randomised (low-level laser therapy arm, n = 44; sham arm, n = 43). The mean age was 59.4 years (standard deviation 8.8 years) and 69 participants (79%) were male. The mean Oral Mucositis Weekly Questionnaire-Head and Neck Cancer score at 6 weeks was 33.2 (standard deviation 10) in the low-level laser therapy arm and 27.4 (standard deviation 13.8) in the sham arm. Limitations: The trial lacked statistical power because it did not meet the recruitment target. Staff and patients willingly participated in the trial and worked hard to make the LiTEFORM trial succeed. However, the task of introducing, embedding and sustaining new low-level laser therapy services into a complex care pathway proved challenging. Sites could deliver low-level laser therapy to only a small number of patients at a time. The administration of low-level laser therapy was viewed as straightforward, but also time-consuming and sometimes uncomfortable for both patients and staff, particularly those staff who were not used to working in a patient’s mouth. Conclusions: This trial had a robust design but lacked power to be definitive. Low-level laser therapy is relatively inexpensive. In contrast with previous trials, some patients found low-level laser therapy sessions to be difficult. The duration of low-level laser therapy sessions is, therefore, an important consideration. Clinicians experienced in oral cavity work most readily adapt to delivering low-level laser therapy, although other allied health professionals can be trained. Blinding the clinicians delivering low-level laser therapy is feasible. There are important human resource, real estate and logistical considerations for those setting up low-level laser therapy services. Future work: Further well-designed randomised controlled trials investigating low-level laser therapy in head and neck cancer irradiation are needed, with similar powered recruitment targets but addressing the recruitment challenges and logistical findings from this research. Trial registration: This trial is registered as ISRCTN14224600. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 46. See the NIHR Journals Library website for further project information.

Direct posterior dental restorations are commonly provided following management of dental caries. Amalgam use has been phased down and the feasibility of a phase-out by 2030 is being explored. Alternative direct restorative materials differ in their outcomes and provision. This research aimed to elicit the UK population’s preferences for different attributes of restorations and their willingness to pay (WTP) for restorative services and outcomes. A discrete choice experiment (DCE) was designed with patient and public involvement and distributed to a representative sample of the UK general population using an online survey. Respondents answered 17 choice tasks between pairs of scenarios that varied in levels of 7 attributes (wait for filling, clinician type, filling color, length of procedure, likely discomfort after filling, average life span of filling, and cost). An opt-out (no treatment) was included. Mixed logit models were used for data analysis. Marginal WTP for attribute levels and relative attribute importance were calculated. In total, 1,002 respondents completed the DCE. Overall, respondents were willing to pay £39.52 to reduce a 6-wk wait for treatment to 2 wk, £13.55 to have treatment by a dentist rather than a therapist, £41.66 to change filling color from silvery/gray to white, £0.27 per minute of reduced treatment time, £116.52 to move from persistent to no postoperative pain, and £5.44 per year of increased restoration longevity. Ability to pay affected willingness to pay, with low-income respondents more likely to opt out of treatment and value restoration color (white) and increased longevity significantly lower than those with higher income. Clinicians should understand potential drivers of restoration choice, so they can be discussed with individual patients to obtain consent. It is important that policy makers consider general population preferences for restorative outcomes and services, with an awareness of how income affects these, when considering the potential phase-out of amalgam restorations.