Nasal sprays and behavioural interventions compared with usual care for acute respiratory illness in primary care: a randomised, controlled, open-label, parallel-group trial.

BACKGROUND: A small amount of evidence suggests that nasal sprays, or physical activity and stress management, could shorten the duration of respiratory infections. This study aimed to assess the effect of nasal sprays or a behavioural intervention promoting physical activity and stress management on respiratory illnesses, compared with usual care. METHODS: This randomised, controlled, open-label, parallel-group trial was done at 332 general practitioner practices in the UK. Eligible adults (aged ≥18 years) had at least one comorbidity or risk factor increasing their risk of adverse outcomes due to respiratory illness (eg, immune compromise due to serious illness or medication; heart disease; asthma or lung disease; diabetes; mild hepatic impairment; stroke or severe neurological problem; obesity [BMI ≥30 kg/m2]; or age ≥65 years) or at least three self-reported respiratory tract infections in a normal year (ie, any year before the COVID-19 pandemic). Participants were randomly assigned (1:1:1:1) using a computerised system to: usual care (brief advice about managing illness); gel-based spray (two sprays per nostril at the first sign of an infection or after potential exposure to infection, up to 6 times per day); saline spray (two sprays per nostril at the first sign of an infection or after potential exposure to infection, up to 6 times per day); or a brief behavioural intervention in which participants were given access to a website promoting physical activity and stress management. The study was partially masked: neither investigators nor medical staff were aware of treatment allocation, and investigators who did the statistical analysis were unaware of treatment allocation. The sprays were relabelled to maintain participant masking. Outcomes were assessed using data from participants' completed monthly surveys and a survey at 6 months. The primary outcome was total number of days of illness due to self-reported respiratory tract illnesses (coughs, colds, sore throat, sinus or ear infections, influenza, or COVID-19) in the previous 6 months, assessed in the modified intention-to-treat population, which included all randomly assigned participants who had primary outcome data available. Key secondary outcomes were possible harms, including headache or facial pain, and antibiotic use, assessed in all randomly assigned participants. This trial was registered with ISRCTN, 17936080, and is closed to recruitment. FINDINGS: Between Dec 12, 2020, and April 7, 2023, of 19 475 individuals screened for eligibility, 13 799 participants were randomly assigned to usual care (n=3451), gel-based nasal spray (n=3448), saline nasal spray (n=3450), or the digital intervention promoting physical activity and stress management (n=3450). 11 612 participants had complete data for the primary outcome and were included in the primary outcome analysis (usual care group, n=2983; gel-based spray group, n=2935; saline spray group, n=2967; behavioural website group, n=2727). Compared with participants in the usual care group, who had a mean of 8·2 (SD 16·1) days of illness, the number of days of illness was significantly lower in the gel-based spray group (mean 6·5 days [SD 12·8]; adjusted incidence rate ratio [IRR] 0·82 [99% CI 0·76-0·90]; p<0·0001) and the saline spray group (6·4 days [12·4]; 0·81 [0·74-0·88]; p<0·0001), but not in the group allocated to the behavioural website (7·4 days [14·7]; 0·97 [0·89-1·06]; p=0·46). The most common adverse event was headache or sinus pain in the gel-based group: 123 (4·8%) of 2556 participants in the usual care group; 199 (7·8%) of 2498 participants in the gel-based group (risk ratio 1·61 [95% CI 1·30-1·99]; p<0·0001); 101 (4·5%) of 2377 participants in the saline group (0·81 [0·63-1·05]; p=0·11); and 101 (4·5%) of 2091 participants in the behavioural intervention group (0·95 [0·74-1·22]; p=0·69). Compared with usual care, antibiotic use was lower for all interventions: IRR 0·65 (95% CI 0·50-0·84; p=0·001) for the gel-based spray group; 0·69 (0·45-0·88; p=0·003) for the saline spray group; and 0·74 (0·57-0·94; p=0·02) for the behavioural website group. INTERPRETATION: Advice to use either nasal spray reduced illness duration and both sprays and the behavioural website reduced antibiotic use. Future research should aim to address the impact of the widespread implementation of these simple interventions. FUNDING: National Institute for Health and Care Research.

Systematic review and narrative description of the outcomes of group preoperative education before elective major surgery.

Background: Group preoperative education is becoming standard care for patients preparing for surgery, alongside optimisation of exercise, diet, and wellbeing. Although patient education is essential, the effectiveness of group education programmes or 'surgery schools' as a means of delivery is unclear. This review examines whether attending group preoperative education improves patient outcomes. Methods: We systematically reviewed studies of group perioperative education before major elective surgery. Observational or intervention studies with a baseline group or control arm were included. All outcomes reported were collected and, where possible, effect estimates were summarised using random effects meta-analysis. Results: Twenty-seven studies reported on 48 different outcomes after group education. Overall, there was a 0.7 (95% confidence interval 0.27-1.13) day reduction in mean length of stay. The odds ratio for postoperative complications after abdominal surgery was 0.56 (95% confidence interval 0.36-0.85; nine studies). Patient-centred outcomes were grouped into themes. Most studies reported a benefit from group education, but only postoperative physical impairment, pain, knowledge, activation, preoperative anxiety, and some elements of quality of life were statistically significant. Conclusion: This review presents a summary of published evidence available for group preoperative education. While these data lend support for such programmes, there is a need for adequately powered prospective studies to evaluate the effectiveness of preoperative education on clinical outcomes and to evaluate whether behaviour change is sustained. Furthermore, the content, timing and mode of delivery, and evaluation measures of preoperative education require standardisation. Systematic review protocol: PROSPERO (166297).

Correction: Experiences of Using Digital Mindfulness-Based Interventions: Rapid Scoping Review and Thematic Synthesis.

[This corrects the article DOI: 10.2196/44220.].

IntEgrating Smoking Cessation treAtment into usual online Psychological care for people with common mEntal illness: Protocol for an online randomised feasibility and pilot study (ESCAPE digital).

BACKGROUND: In the UK, smoking prevalence in people with depression (34%) and anxiety (29%) is more than double that of the general population (13%). People who stop smoking improve their mental health with comparable effect sizes found for antidepressants. In England, online psychological therapy is a standard treatment for depression and anxiety. Online therapy is an acceptable setting for smoking cessation support; however, integrated smoking and mental health support is not available. This novel study aims to assess the acceptability and feasibility of an online smoking cessation intervention, and trial procedures, offered alongside online mental health treatment as it offers increased reach to people with common mental health difficulties who smoke. METHODS: A two-armed; Intervention (Integrated SilverCloud smoking cessation support) and control group (SilverCloud usual care), pragmatic, randomised controlled feasibility trial. We aim to recruit 500 adult smokers eligible for online mental health treatment. Follow-up will be conducted at 3-months and 6-months. We will assess the acceptability and feasibility of the trial procedures (i.e., recruitment, data completeness, self-reported acceptability and satisfaction) and the intervention (i.e., self-reported quit attempt, engagement with the smoking cessation and mental health programs, smoking cessation medicine and e-cigarette use, self-reported acceptability and satisfaction) and pilot clinical outcomes (i.e., biologically validated smoking abstinence, anxiety, depression, quality of health). CONCLUSION: If the Trial is successful, a randomised controlled effectiveness trial will follow to examine whether integrated smoking cessation and mental health treatment increases smoking abstinence and improves depression and anxiety compared to usual care. TRIAL REGISTRATION: ISRCTN10612149 (https://doi.org/10.1186/ISRCTN10612149), 02/02/2023.

Barriers and facilitators to use of digital health tools by healthcare practitioners and their patients, before and during the COVID-19 pandemic: a multimethods study.

OBJECTIVES: To explore how healthcare practitioners (HCPs) made decisions about the implementation of digital health technologies (DHTs) in their clinical practice before and during the COVID-19 pandemic. DESIGN: A multimethods study, comprising semistructured interviews conducted prior to the COVID-19 pandemic, supplemented with an online survey that was conducted during the pandemic with a different sample, to ensure the qualitative findings remained relevant within the rapidly changing healthcare context. Participants were recruited through HCP networks, snowballing and social media. Data were analysed thematically. SETTING: Phone interviews and online survey. PARTICIPANTS: HCPs represented a range of professions from primary and secondary care across England, with varied socioeconomic deprivation. RESULTS: 24 HCPs were interviewed, and 16 HCPs responded to the survey. In the interviews, HCPs described three levels where decisions were made, which determined who would have access to what DHTs: health organisation, HCP and patient levels. These decisions resulted in the unequal implementation of DHTs across health services, created barriers for HCPs using DHTs in their practice and influenced HCPs' decisions on which patients to supply DHTs with. In the survey, HCPs described being provided support to overcome some of the barriers at the organisation and HCP level during the pandemic. However, they cited similar concerns to pre-pandemic about barriers patients faced using DHTs (eg, digital literacy). In the absence of centralised guidance on how to manage these barriers, health services made their own decisions about how to adapt their services for those who struggled with DHTs. CONCLUSIONS: Decision-making at the health organisation, HCP and patient levels influences inequalities in access to DHTs for HCPs and patients. The mobilisation of centralised information and resources during the pandemic can be viewed as good practice for reducing barriers to use of DHTs for HCPs. However, attention must also be paid to reducing barriers to accessing DHTs for patients.

Characterising user engagement with mHealth for chronic disease self-management and impact on machine learning performance.

Mobile Health (mHealth) has the potential to be transformative in the management of chronic conditions. Machine learning can leverage self-reported data collected with apps to predict periods of increased health risk, alert users, and signpost interventions. Despite this, mHealth must balance the treatment burden of frequent self-reporting and predictive performance and safety. Here we report how user engagement with a widely used and clinically validated mHealth app, myCOPD (designed for the self-management of Chronic Obstructive Pulmonary Disease), directly impacts the performance of a machine learning model predicting an acute worsening of condition (i.e., exacerbations). We classify how users typically engage with myCOPD, finding that 60.3% of users engage frequently, however, less frequent users can show transitional engagement (18.4%), becoming more engaged immediately ( < 21 days) before exacerbating. Machine learning performed better for users who engaged the most, however, this performance decrease can be mostly offset for less frequent users who engage more near exacerbation. We conduct interviews and focus groups with myCOPD users, highlighting digital diaries and disease acuity as key factors for engagement. Users of mHealth can feel overburdened when self-reporting data necessary for predictive modelling and confidence of recognising exacerbations is a significant barrier to accurate self-reported data. We demonstrate that users of mHealth should be encouraged to engage when they notice changes to their condition (rather than clinically defined symptoms) to achieve data that is still predictive for machine learning, while reducing the likelihood of disengagement through desensitisation.

Associations of Breathing Pattern Disorder and Nijmegen Score With Clinical Outcomes in Difficult-to-Treat Asthma.

BACKGROUND: Breathing pattern disorder (BPD) reflects altered biomechanical patterns of breathing that drive breathing difficulty and commonly accompanies difficult-to-treat asthma. Diagnosis of BPD has no gold standard, but Nijmegen Questionnaire (NQ) >23 is commonly used. OBJECTIVES: We sought to advance clinical characterization of BPD and better understand the clinical utility of NQ in difficult asthma in patients from the Wessex AsThma CoHort of difficult asthma (WATCH) study. METHODS: Associations between demographic and clinical factors in difficult asthma and BPD, ascertained by clinical diagnosis (yes/no, n = 476), by NQ scores (≤23: normal [no suggestion of BPD] and >23: abnormal [suggested BPD], n = 372), as well as the continuous raw NQ scores were assessed in univariate models to identify significant risk factors associated with the 3 BPD outcomes. For the clinician-diagnosed and NQ-based BPD, associations of continuous factors were assessed using the independent samples t test or the Mann-Whitney U test as appropriate for the data distribution or by the Spearman correlation test. Dichotomous associations were evaluated using χ2 tests. Multivariable logistic (dichotomous outcomes) and linear regression models (continuous outcomes) were developed to identify predictive factors associated with clinician-diagnosed and NQ-based BPD, dichotomous and continuous. Patients with data on NQ scores were grouped into NQ quartiles (low, moderate, high, and very high). The patterns of association of the quartiles with 4 health-related questionnaire outcomes were assessed using linear regression analyses. RESULTS: Multivariable regression identified that clinically diagnosed BPD was associated with female sex (odds ratio [OR]: 1.85; 95% confidence interval [CI]: 1.07, 3.20), comorbidities (rhinitis [OR: 2.46; 95% CI: 1.45, 4.17], gastroesophageal reflux disease [GORD] [OR: 2.77; 95% CI: 1.58, 4.84], inducible laryngeal obstruction [OR: 4.37; 95% CI: 2.01, 9.50], and any psychological comorbidity [OR: 1.86; 95% CI: 1.13, 3.07]), and health care usage (exacerbations [OR: 1.07; 95% CI: 1.003, 1.14] and previous intensive care unit (ICU) admissions [OR: 2.03; 95% CI: 1.18, 3.47]). Abnormal NQ-based BPD diagnosis was associated with history of eczema (OR: 1.83; 95% CI: 1.07, 3.14), GORD (OR: 1.94; 95% CI: 1.15, 3.27), or any psychological comorbidity (OR: 4.29; 95% CI: 2.64, 6.95) at multivariable regression. Differences between clinical and NQ-based BPD traits were also found with 42% discordance in BPD state between these definitions. Multivariable linear regression analysis with NQ as a continuous outcome showed positive association with worse asthma outcomes (admission to ICU, P = .037), different phenotypic traits (female sex, P = .001; ever smoker, P = .025), and greater multimorbidity (GORD, P = .002; sleep apnea, P = .04; and any psychological comorbidity, P < .0001). CONCLUSION: BPD is associated with worse health outcomes and negative health impacts in difficult asthma within a multimorbidity disease model. It therefore merits better recognition and prompt treatment. Clinical diagnosis and NQ offer different perspectives on BPD, so this goal may be best addressed by considering clinical features alongside the magnitude of NQ.

Implementing Germ Defence digital behaviour change intervention via all primary care practices in England to reduce respiratory infections during the COVID-19 pandemic: an efficient cluster randomised controlled trial using the OpenSAFELY platform.

BACKGROUND: Germ Defence ( www.germdefence.org ) is an evidence-based interactive website that promotes behaviour change for infection control within households. To maximise the potential of Germ Defence to effectively reduce the spread of COVID-19, the intervention needed to be implemented at scale rapidly. METHODS: With NHS England approval, we conducted an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via general practitioner (GP) practices across England, UK, compared with usual care to disseminate Germ Defence to patients. GP practices randomised to the intervention arm (n = 3292) were emailed and asked to disseminate Germ Defence to all adult patients via mobile phone text, email or social media. Usual care arm GP practices (n = 3287) maintained standard management for the 4-month trial period and then asked to share Germ Defence with their adult patients. The primary outcome was the rate of GP presentations for respiratory tract infections (RTI) per patient. Secondary outcomes comprised rates of acute RTIs, confirmed COVID-19 diagnoses and suspected COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic usage and hospital admissions. The impact of the intervention on outcome rates was assessed using negative binomial regression modelling within the OpenSAFELY platform. The uptake of the intervention by GP practice and by patients was measured via website analytics. RESULTS: Germ Defence was used 310,731 times. The average website satisfaction score was 7.52 (0-10 not at all to very satisfied, N = 9933). There was no evidence of a difference in the rate of RTIs between intervention and control practices (rate ratio (RR) 1.01, 95% CI 0.96, 1.06, p = 0.70). This was similar to all other eight health outcomes. Patient engagement within intervention arm practices ranged from 0 to 48% of a practice list. CONCLUSIONS: While the RCT did not demonstrate a difference in health outcomes, we demonstrated that rapid large-scale implementation of a digital behavioural intervention is possible and can be evaluated with a novel efficient prospective RCT methodology analysing routinely collected patient data entirely within a trusted research environment. TRIAL REGISTRATION: This trial was registered in the ISRCTN registry (14602359) on 12 August 2020.

Applying machine-learning to rapidly analyze large qualitative text datasets to inform the COVID-19 pandemic response: comparing human and machine-assisted topic analysis techniques.

Introduction: Machine-assisted topic analysis (MATA) uses artificial intelligence methods to help qualitative researchers analyze large datasets. This is useful for researchers to rapidly update healthcare interventions during changing healthcare contexts, such as a pandemic. We examined the potential to support healthcare interventions by comparing MATA with "human-only" thematic analysis techniques on the same dataset (1,472 user responses from a COVID-19 behavioral intervention). Methods: In MATA, an unsupervised topic-modeling approach identified latent topics in the text, from which researchers identified broad themes. In human-only codebook analysis, researchers developed an initial codebook based on previous research that was applied to the dataset by the team, who met regularly to discuss and refine the codes. Formal triangulation using a "convergence coding matrix" compared findings between methods, categorizing them as "agreement", "complementary", "dissonant", or "silent". Results: Human analysis took much longer than MATA (147.5 vs. 40 h). Both methods identified key themes about what users found helpful and unhelpful. Formal triangulation showed both sets of findings were highly similar. The formal triangulation showed high similarity between the findings. All MATA codes were classified as in agreement or complementary to the human themes. When findings differed slightly, this was due to human researcher interpretations or nuance from human-only analysis. Discussion: Results produced by MATA were similar to human-only thematic analysis, with substantial time savings. For simple analyses that do not require an in-depth or subtle understanding of the data, MATA is a useful tool that can support qualitative researchers to interpret and analyze large datasets quickly. This approach can support intervention development and implementation, such as enabling rapid optimization during public health emergencies.

The Effectiveness of Fully Automated Digital Interventions in Promoting Mental Well-Being in the General Population: Systematic Review and Meta-Analysis.

BACKGROUND: Recent years have highlighted an increasing need to promote mental well-being in the general population. This has led to a rapidly growing market for fully automated digital mental well-being tools. Although many individuals have started using these tools in their daily lives, evidence on the overall effectiveness of digital mental well-being tools is currently lacking. OBJECTIVE: This study aims to review the evidence on the effectiveness of fully automated digital interventions in promoting mental well-being in the general population. METHODS: Following the preregistration of the systematic review protocol on PROSPERO, searches were carried out in MEDLINE, Web of Science, Cochrane, PsycINFO, PsycEXTRA, Scopus, and ACM Digital (initial searches in February 2022; updated in October 2022). Studies were included if they contained a general population sample and a fully automated digital intervention that exclusively used psychological mental well-being promotion activities. Two reviewers, blinded to each other's decisions, conducted data selection, extraction, and quality assessment of the included studies. Narrative synthesis and a random-effects model of per-protocol data were adopted. RESULTS: We included 19 studies that involved 7243 participants. These studies included 24 fully automated digital mental well-being interventions, of which 15 (63%) were included in the meta-analysis. Compared with no intervention, there was a significant small effect of fully automated digital mental well-being interventions on mental well-being in the general population (standardized mean difference 0.19, 95% CI 0.04-0.33; P=.02). Specifically, mindfulness-, acceptance-, commitment-, and compassion-based interventions significantly promoted mental well-being in the general population (P=.006); insufficient evidence was available for positive psychology and cognitive behavioral therapy-based interventions; and contraindications were found for integrative approaches. Overall, there was substantial heterogeneity, which could be partially explained by the intervention duration, comparator, and study outcomes. The risk of bias was high, and confidence in the quality of the evidence was very low (Grading of Recommendations, Assessment, Development, and Evaluations), primarily because of the high rates of study dropout (average 37%; range 0%-85%) and suboptimal intervention adherence (average 40%). CONCLUSIONS: This study provides a novel contribution to knowledge regarding the effectiveness, strengths, and weaknesses of fully automated digital mental well-being interventions in the general population. Future research and practice should consider these findings when developing fully automated digital mental well-being tools. In addition, research should aim to investigate positive psychology and cognitive behavioral therapy-based tools as well as develop further strategies to improve adherence and reduce dropout in fully automated digital mental well-being interventions. Finally, it should aim to understand when and for whom these interventions are particularly beneficial. TRIAL REGISTRATION: PROSPERO CRD42022310702; https://tinyurl.com/yc7tcwy7.

Experiences of Using Digital Mindfulness-Based Interventions: Rapid Scoping Review and Thematic Synthesis.

BACKGROUND: Digital mindfulness-based interventions (MBIs) are a promising approach to deliver accessible and scalable mindfulness training and have been shown to improve a range of health outcomes. However, the success of digital MBIs is reliant on adequate engagement, which remains a crucial challenge. Understanding people's experiences of using digital MBIs and identifying the core factors that facilitate or act as barriers to engagement is essential to inform intervention development and maximize engagement and outcomes. OBJECTIVE: This study aims to systematically map the literature on people's experiences of using digital MBIs that target psychosocial variables (eg, anxiety, depression, distress, and well-being) and identify key barriers to and facilitators of engagement. METHODS: We conducted a scoping review to synthesize empirical qualitative research on people's experiences of using digital MBIs. We adopted a streamlined approach to ensure that the evidence could be incorporated into the early stages of intervention development. The search strategy identified articles with at least one keyword related to mindfulness, digital, user experience, and psychosocial variables in their title or abstract. Inclusion criteria specified that articles must have a qualitative component, report on participants' experiences of using a digital MBI designed to improve psychosocial variables, and have a sample age range that at least partially overlapped with 16 to 35 years. Qualitative data on user experience were charted and analyzed using inductive thematic synthesis to generate understandings that go beyond the content of the original studies. We used the Quality of Reporting Tool to critically appraise the included sources of evidence. RESULTS: The search identified 510 studies, 22 (4.3%) of which met the inclusion criteria. Overall, the samples were approximately 78% female and 79% White; participants were aged between 16 and 69 years; and the most used measures in intervention studies were mindfulness, psychological flexibility, and variables related to mental health (including depression, anxiety, stress, and well-being). All studies were judged to be adequately reported. We identified 3 themes characterizing barriers to and facilitators of engagement: responses to own practice (ie, negative reactions to one's own practice are common and can deplete motivation), making mindfulness a habit (ie, creating a consistent training routine is essential yet challenging), and leaning on others (ie, those engaging depend on someone else for support). CONCLUSIONS: The themes identified in this review provide crucial insights as to why people frequently stop engaging with digital MBIs. Researchers and developers should consider using person-based coparticipatory methods to improve acceptability of and engagement with digital MBIs, increase their effectiveness, and support their translation to real-world use. Such strategies must be grounded in relevant literature and meet the priorities and needs of the individuals who will use the interventions.

Engagement with a nationally-implemented digital behaviour change intervention: Usage patterns over the 9-month duration of the National Health Service Digital Diabetes Prevention Programme.

Background: Digital behaviour change interventions may offer a scalable way to promote weight loss by increasing physical activity and improving diet. However, user engagement is necessary for such benefits to be achieved. There is a dearth of research that assesses engagement with nationally implemented digital programmes offered in routine practice. The National Health Service Digital Diabetes Prevention Programme (NHS-DDPP) is a nine-month digital behaviour change intervention delivered by independent providers for adults in England who are at high risk of developing type 2 diabetes. This study reports engagement with the NHS-DDPP for users enrolled onto the programme over the nine-month duration. Methods: Anonymous usage data was obtained for a cohort of service users (n = 1826) enrolled on the NHS-DDPP with three independent providers, between December 2020 and June 2021. Usage data were obtained for time spent in app, and frequency of use of NHS-DDPP intervention features in the apps including self-monitoring, goal setting, receiving educational content (via articles) and social support (via health coaches and group forums), to allow patterns of usage of these key features to be quantified across the nine-month intervention. Median usage was calculated within nine 30-day engagement periods to allow a longitudinal analysis of the dose of usage for each feature. Results: App usage declined from a median of 32 min (IQR 191) in month one to 0 min (IQR 14) in month nine. Users self-monitored their behaviours (e.g., physical activity and diet) a median of 117 times (IQR 451) in the apps over the nine-month programme. The open group discussion forums were utilised less regularly (accessed a median of 0 times at all time-points). There was higher engagement with some intervention features (e.g., goal setting) when support from a health coach was linked to those features. Conclusions: App usage decreased over the nine-month programme, although the rate at which the decrease occurred varied substantially between individuals and providers. Health coach support may promote engagement with specific intervention features. Future research should assess whether engagement with particular features of digital diabetes prevention programmes is associated with outcomes such as reduced bodyweight and HbA1c levels.

Determining the clinical and cost-effectiveness of nasal sprays and a physical activity and stress management intervention to reduce respiratory tract infections in primary care: A protocol for the 'Immune Defence' randomised controlled trial.

BACKGROUND: Most adults in the UK experience at least one viral respiratory tract infection (RTI) per year. Individuals with comorbidities and those with recurrent RTIs are at higher risk of infections. This can lead to more severe illness, worse quality of life and more days off work. There is promising evidence that using common nasal sprays or improving immune function through increasing physical activity and managing stress, may reduce the incidence and severity of RTIs. METHODS AND DESIGN: Immune Defence is an open, parallel group, randomised controlled trial. Up to 15000 adults from UK general practices, with a comorbidity or risk factor for infection and/or recurrent infections (3 or more infections per year) will be randomly allocated to i) a gel-based nasal spray designed to inhibit viral respiratory infections; ii) a saline nasal spray, iii) a digital intervention promoting physical activity and stress management, or iv) usual care with brief advice for managing infections, for 12 months. Participants will complete monthly questionnaires online. The primary outcome is the total number of days of illness due to RTIs over 6 months. Key secondary outcomes include: days with symptoms moderately bad or worse; days where work/normal activities were impaired; incidence of RTI; incidence of COVID-19; health service contacts; antibiotic usage; beliefs about antibiotics; intention to consult; number of days of illness in total due to respiratory tract infections over 12 months. Economic evaluation from an NHS perspective will compare the interventions, expressed as incremental cost effectiveness ratios. A nested mixed methods process evaluation will examine uptake and engagement with the interventions and trial procedures. TRIAL STATUS: Recruitment commenced in December 2020 and the last participant is expected to complete the trial in April 2024. DISCUSSION: Common nasal sprays and digital interventions to promote physical activity and stress management are low cost, accessible interventions applicable to primary care. If effective, they have the potential to reduce the individual and societal impact of RTIs. TRIAL REGISTRATION: Prospectively registered with ISRCTN registry (17936080) on 30/10/2020. SPONSOR: This RCT is sponsored by University of Southampton. The sponsors had no role in the study design, decision to publish, or preparation of the manuscript.

What bothers severe asthma patients most? A paired patient-clinician study across seven European countries.

Introduction: Severe asthma is a complex, multidimensional disease. Optimal treatment, adherence and outcomes require shared decision-making, rooted in mutual understanding between patient and clinician. This study used a novel, patient-centred approach to examine the most bothersome aspects of severe asthma to patients, as seen from both perspectives in asthma registries. Methods: Across seven countries, 126 patients with severe asthma completed an open-ended survey regarding most the bothersome aspect(s) of their asthma. Patients' responses were linked with their treating clinician who also completed a free-text survey about each patient's most bothersome aspect(s). Responses were coded using content analysis, and patient and clinician responses were compared. Finally, asthma registries that are part of the SHARP (Severe Heterogeneous Asthma Research collaboration, Patient-centred) Clinical Research Collaboration were examined to see the extent to which they reflected the most bothersome aspects reported by patients. Results: 88 codes and 10 themes were identified. Clinicians were more focused on direct physical symptoms and were less focused on "holistic" aspects such as the effort required to self-manage the disease. Clinicians accurately identified a most bothersome symptom for 29% of patients. Agreement was particularly low with younger patients and those using oral corticosteroids infrequently. In asthma registries, patient aspects were predominantly represented in questionnaires. Conclusions: Results demonstrated different perspectives and priorities between patients and clinicians, with clinicians more focused on physical aspects. These differences must be considered when treating individual patients, and within multidisciplinary treatment teams. The use of questionnaires that include multifaceted aspects of disease may result in improved asthma research.

The role of emotion regulation in the relationship between mindfulness and risk factors for disordered eating: A longitudinal mediation analysis.

OBJECTIVE: Evidence suggests mindfulness may reduce risk factors for disordered eating. However, mechanisms of change in this relationship are unclear. This longitudinal study tested whether emotion regulation mediates the prospective associations between mindfulness and two proximal risk factors for disordered eating: weight and shape concerns, and negative affect. METHOD: This study is a secondary analysis of data collected within an eating disorder prevention trial. Adolescent girls (N = 374, Mage  = 15.70, SD = 0.77) completed self-report measures of mindfulness, emotion regulation, weight and shape concerns, and negative affect at baseline, 2 months following baseline, and 7 months following baseline. Path analyses were computed to test hypothesized indirect effects using confidence intervals based on 5000 bootstrap samples. RESULTS: Higher baseline mindfulness predicted lower weight and shape concerns and negative affect at 7 months via a mediator of better emotion regulation at 2 months. This effect remained while controlling for earlier measurements of the mediator and outcome in the model of negative affect but not weight and shape concerns. DISCUSSION: Emotion regulation may be an important mechanism explaining how mindfulness influences negative affect. Efforts should be made to intervene on mindfulness and emotion regulation in prevention and early intervention programmes for eating disorders and other psychiatric conditions. PUBLIC SIGNIFICANCE: Research has shown that mindfulness can help to reduce some of the risk of developing an eating disorder. This study explored whether mindfulness reduces some of this risk by helping people to better manage their emotions. Understanding this process can help us to develop better mindfulness-based strategies to support people who are at risk of developing an eating disorder.

Exercising body but not mind: A qualitative exploration of attitudes to combining physical activity and mindfulness practice for mental health promotion.

Background: Physical activity and mindfulness meditation can be effective for maintaining good mental wellbeing, with early-stage research suggesting even greater effectiveness in tandem. Literature is lacking on the perceptions and acceptability of these practices, particularly in a preventative context. The study aimed to explore attitudes toward mental health and its maintenance through physical activity and mindfulness meditation in the university student population. Methods: Semi-structured qualitative interviews were conducted with a sample of 16 students from 10 United Kingdom universities (M age = 23 years, SD = 3.22) recruited through social media and stratified to have varied wellbeing symptoms, physical activity levels, and experience with mindfulness meditation. Reflexive thematic analysis was used to elicit meaning from the data. Results: Four main themes were constructed. Participants held a "Dualist view of health," in which mental and physical aspects were seen as distinct but connected, and prioritized physical health maintenance. The "Low-point paradox," where engagement is most difficult during the time of greatest need, was identified as a crucial psychological barrier across health behaviors. "Unfamiliarity with mindfulness practice" was common, as were misconceptions inhibiting practice. Finally, participants were intrigued by combining physical activity and mindfulness, supposing that "Whole is greater than the sum of its parts," with mutual reinforcement of the two techniques cited as biggest motivating factor. Conclusion: Effective preventative mental health strategies for adults, including university students, should accommodate for common psychological barriers and facilitators to health maintenance behaviors, including misconceptions surrounding mindfulness, to increase acceptability. Combining physical activity and mindfulness meditation is one promising preventative approach that warrants further investigation.

Multimorbidity in Difficult Asthma: The Need for Personalised and Non-Pharmacological Approaches to Address a Difficult Breathing Syndrome.

Three to ten percent of people living with asthma have difficult-to-treat asthma that remains poorly controlled despite maximum levels of guideline-based pharmacotherapy. This may result from a combination of multiple adverse health issues including aggravating comorbidities, inadequate treatment, suboptimal inhaler technique and/or poor adherence that may individually or collectively contribute to poor asthma control. Many of these are potentially "treatable traits" that can be pulmonary, extrapulmonary, behavioural or environmental factors. Whilst evidence-based guidelines lead clinicians in pharmacological treatment of pulmonary and many extrapulmonary traits, multiple comorbidities increase the burden of polypharmacy for the patient with asthma. Many of the treatable traits can be addressed with non-pharmacological approaches. In the current healthcare model, these are delivered by separate and often disjointed specialist services. This leaves the patients feeling lost in a fragmented healthcare system where clinical outcomes remain suboptimal even with the best current practice applied in each discipline. Our review aims to address this challenge calling for a paradigm change to conceptualise difficult-to-treat asthma as a multimorbid condition of a "Difficult Breathing Syndrome" that consequently needs a holistic personalised care attitude by combining pharmacotherapy with the non-pharmacological approaches. Therefore, we propose a roadmap for an evidence-based multi-disciplinary stepped care model to deliver this.

Planning a digital intervention for adolescents with asthma (BREATHE4T): A theory-, evidence- and Person-Based Approach to identify key behavioural issues.

OBJECTIVES: To describe a transparent approach to planning a digital intervention for adolescents to self-manage their asthma using breathing retraining (BRT), based on an existing, effective adult intervention (BREATHE). METHODS: A theory-, evidence-, and Person-Based Approach was used to maximise the effectiveness and persuasiveness of the intervention. A scoping review and semistructured interviews with target intervention users (N = 18, adolescents aged 12-17 years with asthma and parents) were carried out to explore user perspectives, barriers, and facilitators towards the intended behaviours and potential intervention features. The combined evidence was used alongside and to inform theory-based activities and enabled iterative planning of the intervention. RESULTS: The scoping review identified themes relating to user-specific self-management issues, content, education, training needs, and features for a digital intervention. Interviews elicited potential barriers to intended behaviours such as the anticipated embarrassment of using BRT and concerns around remaining calm. Facilitators included BRT delivered by adolescents who share experiences of asthma and information for performing exercises discreetly. Relevant theoretical frameworks ensured that appropriate psychological constructs were targeted. A behavioural analysis identified six intervention functions and thirty behaviour change techniques. Logic modelling mapped the programme theory and mechanisms, which aims to improve adolescent asthma-related quality of life. CONCLUSIONS: This study gives a transparent insight into the approach followed to plan a self-guided BRT intervention for adolescents and has led to identification of key behavioural issues, enabling relevant intervention content to be chosen. Insight has been given into adolescent perceptions of BRT, which facilitated development of the prototype intervention.

Experience of adults with upper-limb difference and their views on sensory feedback for prostheses: a mixed methods study.

BACKGROUND: Upper-limb prostheses are regularly abandoned, in part due to the mismatch between user needs and prostheses performance. Sensory feedback is among several technological advances that have been proposed to reduce device abandonment rates. While it has already been introduced in some high-end commercial prostheses, limited data is available about user expectations in relation to sensory feedback. The aim of this study is thus to use a mixed methods approach to provide a detailed insight of users' perceptions and expectations of sensory feedback technology, to ensure the addition of sensory feedback is as acceptable, engaging and ultimately as useful as possible for users and, in turn, reduce the reliance on compensatory movements that lead to overuse syndrome. METHODS: The study involved an online survey (N = 37) and video call interviews (N = 15) where adults with upper-limb differences were asked about their experience with limb difference and prosthesis use (if applicable) and their expectations about sensory feedback to prostheses. The survey data were analysed quantitatively and descriptively to establish the range of sensory feedback needs and their variations across the different demographics. Reflexive thematic analysis was performed on the interview data, and data triangulation was used to understand key behavioural issues to generate actionable guiding principles for the development of sensory feedback systems. RESULTS: The survey provided a list of practical examples and suggestions that did not vary with the different causes of limb difference or prosthesis use. The interviews showed that although sensory feedback is a desired feature, it must prove to have more benefits than drawbacks. The key benefit mentioned by participants was increasing trust, which requires a highly reliable system that provides input from several areas of the hand rather than just the fingertips. The feedback system should also complement existing implicit feedback sources without causing confusion or discomfort. Further, the effect sensory feedback has on the users' psychological wellbeing was highlighted as an important consideration that varies between individuals and should therefore be discussed. The results obtained were used to develop guiding principles for the design and implementation of sensory feedback systems. CONCLUSIONS: This study provides a mixed-methods research on the sensory feedback needs of adults with upper-limb differences, enabling a deeper understanding of their expectations and worries. Guiding principles were developed based on the results of a survey and interviews to inform the development and assessment of sensory feedback for upper-limb prostheses.

Using nasal sprays to prevent respiratory tract infections: a qualitative study of online consumer reviews and primary care patient interviews.

OBJECTIVES: Nasal sprays could be a promising approach to preventing respiratory tract infections (RTIs). This study explored lay people's perceptions and experiences of using nasal sprays to prevent RTIs to identify barriers and facilitators to their adoption and continued use. DESIGN: Qualitative research. Study 1 thematically analysed online consumer reviews of an RTI prevention nasal spray. Study 2 interviewed patients about their reactions to and experiences of a digital intervention that promotes and supports nasal spray use for RTI prevention (reactively: at 'first signs' of infection and preventatively: following possible/probable exposure to infection). Interview transcripts were analysed using thematic analysis. SETTING: Primary care, UK. PARTICIPANTS: 407 online customer reviews. 13 purposively recruited primary care patients who had experienced recurrent infections and/or had risk factors for severe infections. RESULTS: Both studies identified various factors that might influence nasal spray use including: high motivation to avoid RTIs, particularly during the COVID-19 pandemic; fatalistic views about RTIs; beliefs about alternative prevention methods; the importance of personal recommendation; perceived complexity and familiarity of nasal sprays; personal experiences of spray success or failure; tolerable and off-putting side effects; concerns about medicines; and the nose as unpleasant and unhygienic. CONCLUSIONS: People who suffer disruptive, frequent or severe RTIs or who are vulnerable to RTIs are interested in using a nasal spray for prevention. They also have doubts and concerns and may encounter problems. Some of these may be reduced or eliminated by providing nasal spray users with information and advice that addresses these concerns or helps people overcome difficulties.