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

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

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.

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.

A feasibility trial of a digital mindfulness-based intervention to improve asthma-related quality of life for primary care patients with asthma.

Asthma outcomes remain suboptimal, despite effective pharmacotherapy. Psychological dysfunction (such as anxiety) is common, and associated with poorer outcomes. We evaluated a digital mindfulness programme as an intervention to improve asthma-related quality of life for primary care patients, in a prospectively registered randomized-controlled feasibility study. We offered 'Headspace', a widely-used digital mindfulness intervention, to adults with asthma through 16 UK GP practices. Participants were randomized on a 2:1 basis to the mindfulness intervention, or waitlist control. Participants completed questionnaires (including asthma symptom control, asthma-related quality of life, anxiety, depression) at baseline, 6-week and 3-month follow-up. 116 participants completed primary outcomes at 3-month follow-up: intervention 73 (79%), control 43 (84%). Compared to baseline, the intervention group but not the control group reported significantly improved asthma-related quality of life, with a between-group difference favoring the intervention group that was not significant (Mean difference = 0.15, 95%CI - 0.13 to 0.42). Intervention use varied (ranging from 0 to 192 times) but was generally high. Digital mindfulness interventions are feasible and acceptable adjunct treatments for mild and moderate asthma to target quality of life. Further research should adapt 'generic' mindfulness-based stress-reduction to maximize effectiveness for asthma, and validate our findings in a fully-powered randomized controlled trial.Trial registration Prospectively registered: ISRCTN52212323.

A qualitative study exploring the barriers to attending structured education programmes among adults with type 2 diabetes.

BACKGROUND: Diabetes self-management education, a universally recommended component of diabetes care, aims to support self-management in people with type 2 diabetes. However, attendance is low (approx. 10%). Previous research investigating the reasons for low attendance have not yet linked findings to theory, making it difficult to translate findings into practice. This study explores why some adults with type 2 diabetes do not attend diabetes self-management education and considers how services can be adapted accordingly, using Andersen's Behavioural Model of Health Service Utilisation as a framework. METHODS: A cross-sectional semi-structured qualitative interview study was carried out. Semi-structured interviews were conducted by telephone with 14 adults with type 2 diabetes who had verbally declined their invitation to attend diabetes self-management education in Bath and North East Somerset, UK, within the last 2 years. Data were analysed using inductive thematic analysis before mapping the themes onto the factors of Andersen's Behavioural Model. RESULTS: Two main themes were identified: 'perceived need' and 'practical barriers'. The former theme explored participants' tendency to decline diabetes education when they perceived they did not need the programme. This perception tended to arise from participants' high self-efficacy to manage their type 2 diabetes, the low priority they attributed to their condition and limited knowledge about the programme. The latter theme, 'practical barriers', explored the notion that some participants wanted to attend but were unable to due to other commitments and/or transportation issues in getting to the venue. CONCLUSIONS: All sub-themes resonated with one or more factors of Andersen's Behavioural Model indicating that the model may help to elucidate attendance barriers and ways to improve services. To fully understand low attendance to diabetes education, the complex and individualised reasons for non-attendance must be recognised and a person-centred approach should be taken to understand people's experience, needs and capabilities.

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.

Effectiveness of digital interventions to improve household and community infection prevention and control behaviours and to reduce incidence of respiratory and/or gastro-intestinal infections: a rapid systematic review.

BACKGROUND: Digital interventions have potential to efficiently support improved hygiene practices to reduce transmission of COVID-19. OBJECTIVE: To evaluate the evidence for digital interventions to improve hygiene practices within the community. METHODS: We reviewed articles published between 01 January 2000 and 26 May 2019 that presented a controlled trial of a digital intervention to improve hygiene behaviours in the community. We searched MEDLINE, Embase, PsycINFO, Cochrane Controlled Register of Trials (CENTRAL), China National Knowledge Infrastructure and grey literature. Trials in hospitals were excluded, as were trials aiming at prevention of sexually transmitted infections; only target diseases with transmission mechanisms similar to COVID-19 (e.g. respiratory and gastrointestinal infections) were included. Trials had to evaluate a uniquely digital component of an intervention. Study designs were limited to randomised controlled trials, controlled before-and-after trials, and interrupted time series analyses. Outcomes could be either incidence of infections or change in hygiene behaviours. The Risk of Bias 2 tool was used to assess study quality. RESULTS: We found seven studies that met the inclusion criteria. Six studies reported successfully improving self-reported hygiene behaviour or health outcomes, but only one of these six trials, Germ Defence, confirmed improvements using objective measures (reduced consultations and antibiotic prescriptions). Settings included kindergartens, workplaces, and service station restrooms. Modes of delivery were diverse: WeChat, website, text messages, audio messages to mobiles, electronic billboards, and electronic personal care records. Four interventions targeted parents of young children with educational materials. Two targeted the general population; these also used behaviour change techniques or theory to inform the intervention. Only one trial had low risk of bias, Germ Defence; the most common concerns were lack of information about the randomisation, possible bias in reporting of behavioural outcomes, and lack of an analysis plan and possible selective reporting of results. CONCLUSION: There was only one trial that was judged to be at low risk of bias, Germ Defence, which reduced incidence and severity of illness, as confirmed by objective measures. Further evaluation is required to determine the effectiveness of the other interventions reviewed. TRIAL REGISTRATION: PROSPERO CRD42020189919 .

A Web-Based Intervention (Germ Defence) to Increase Handwashing During a Pandemic: Process Evaluations of a Randomized Controlled Trial and Public Dissemination.

BACKGROUND: Washing hands helps prevent transmission of seasonal and pandemic respiratory viruses. In a randomized controlled trial (RCT) during the swine flu outbreak, participants with access to a fully automated, digital intervention promoting handwashing reported washing their hands more often and experienced fewer respiratory tract infections than those without access to the intervention. Based on these findings, the intervention was adapted, renamed as "Germ Defence," and a study was designed to assess the preliminary dissemination of the intervention to the general public to help prevent the spread of seasonal colds and flu. OBJECTIVE: This study compares the process evaluations of the RCT and Germ Defence dissemination to examine (1) how web-based research enrollment procedures affected those who used the intervention, (2) intervention usage in the 2 contexts, and (3) whether increased intentions to wash hands are replicated once disseminated. METHODS: The RCT ran between 2010 and 2012 recruiting participants offline from general practices, with restricted access to the intervention (N=9155). Germ Defence was disseminated as an open access website for use by the general public from 2016 to 2019 (N=624). The process evaluation plan was developed using Medical Research Council guidance and the framework for Analyzing and Measuring Usage and Engagement Data. Both interventions contained a goal-setting section where users self-reported current and intended handwashing behavior across 7 situations. RESULTS: During web-based enrolment, 54.3% (17,511/32,250) of the RCT participants dropped out of the study compared to 36.5% (358/982) of Germ Defence users. Having reached the start of the intervention, 93.8% (8586/9155) of RCT users completed the core section, whereas 65.1% (406/624) of Germ Defence users reached the same point. Users across both studies selected to increase their handwashing in 5 out of 7 situations, including before eating snacks (RCT mean difference 1.040, 95% CI 1.016-1.063; Germ Defence mean difference 0.949, 95% CI 0.766-1.132) and after blowing their nose, sneezing, or coughing (RCT mean difference 0.995, 95% CI 0.972-1.019; Germ Defence mean difference 0.842, 95% CI 0.675-1.008). CONCLUSIONS: By comparing the preliminary dissemination of Germ Defence to the RCT, we were able to examine the potential effects of the research procedures on uptake and attrition such as the sizeable dropout during the RCT enrolment procedure that may have led to a more motivated sample. The Germ Defence study highlighted the points of attrition within the intervention. Despite sample bias in the trial context, the intervention replicated increases in intentions to handwash when used "in the wild." This preliminary dissemination study informed the adaptation of the intervention for the COVID-19 health emergency, and it has now been disseminated globally. TRIAL REGISTRATION: ISRCTN Registry ISRCTN75058295; https://www.isrctn.com/ISRCTN75058295.

Infection Control Behavior at Home During the COVID-19 Pandemic: Observational Study of a Web-Based Behavioral Intervention (Germ Defence).

BACKGROUND: To control the COVID-19 pandemic, people should adopt protective behaviors at home (self-isolation, social distancing, putting shopping and packages aside, wearing face coverings, cleaning and disinfecting, and handwashing). There is currently limited support to help individuals conduct these behaviors. OBJECTIVE: This study aims to report current household infection control behaviors in the United Kingdom and examine how they might be improved. METHODS: This was a pragmatic cross-sectional observational study of anonymous participant data from Germ Defence between May 6-24, 2020. Germ Defence is an open-access fully automated website providing behavioral advice for infection control within households. A total of 28,285 users sought advice from four website pathways based on household status (advice to protect themselves generally, to protect others if the user was showing symptoms, to protect themselves if household members were showing symptoms, and to protect a household member who is at high risk). Users reported current infection control behaviors within the home and intentions to change these behaviors. RESULTS: Current behaviors varied across all infection control measures but were between sometimes (face covering: mean 1.61, SD 1.19; social distancing: mean 2.40, SD 1.22; isolating: mean 2.78, SD 1.29; putting packages and shopping aside: mean 2.75, SD 1.55) and quite often (cleaning and disinfecting: mean 3.17, SD 1.18), except for handwashing (very often: mean 4.00, SD 1.03). Behaviors were similar regardless of the website pathway used. After using Germ Defence, users recorded intentions to improve infection control behavior across all website pathways and for all behaviors (overall average infection control score mean difference 0.30, 95% CI 0.29-0.31). CONCLUSIONS: Self-reported infection control behaviors other than handwashing are lower than is optimal for infection prevention, although handwashing is much higher. Advice using behavior change techniques in Germ Defence led to intentions to improve these behaviors. Promoting Germ Defence within national and local public health and primary care guidance could reduce COVID-19 transmission.

Impact of Personal Alcohol Consumption on Aspects of Medical Student Alcohol-Related Competencies.

AIM: As part of the prevention and management of alcohol-related harms, health professionals need to be competent to assess the level of alcohol use in patients. In this study, we explored how medical students' own alcohol consumption impacts on their familiarity with alcohol brands, strengths and alcohol-related harms. METHODS: As part of a wider study investigating the concept of 'alcohol health literacy', this study combined an anonymous online survey, linked to an electronic alcohol 'brand' recognition game. Participants were medical students in their first clinical year. The survey recorded demographics, self-reported alcohol consumption (using the AUDIT-C), a visual test of relative alcohol concentrations of wine, beer and spirits, and a free-text response asking them to list alcohol-related harms. Participants then completed the brand recognition game recording accuracy and reaction time for identifying alcohol drink brands. RESULTS: One hundred and fifty students participated. There was a significant effect of ethnicity on drinking status, with 48% of non-white participants scoring zero on the AUDIT-C. Students who reported any alcohol consumption were more likely to correctly assess relative alcohol concentrations and were faster and more accurate at recognizing alcohol brands, which was dose dependent. Overall, only 45% correctly recognized relative alcohol strengths of drinks presented. CONCLUSIONS: Among third-year medical students, ability to correctly identify relative strengths of alcoholic drinks is low. As might be expected, students who drink alcohol tend to identify brands and strengths more accurately. This has implications for how best to tailor the delivery of teaching and training about alcohol to ensure similar levels of clinical confidence in dealing with future patients regardless of personal experience.

Evaluation of a breathing retraining intervention to improve quality of life in asthma: quantitative process analysis of the BREATHE randomized controlled trial.

OBJECTIVE: Explore qualitative differences between interventions (DVD and booklet (DVDB) versus face-to-face and booklet (F2FB) versus usual care) in the BREATHE (Breathing Retraining for Asthma Trial of Home Exercises) trial of breathing retraining for asthma. DESIGN: Quantitative process analysis exploring group expectancy, experience and practice before and after intervention delivery for the main trial. SETTING: Primary care. SUBJECTS: Adults with asthma (DVD and booklet, n = 261; F2FB, n = 132). MAIN MEASURES: Baseline - expectancy about breathing retraining; follow-up 3, 6 and 12 months - self-efficacy, treatment experience (enjoyment of treatment, perceptions of physiotherapist, perceptions of barriers), amount of practice (weeks, days/week, times/day), continued practice; all time points - anxiety (Hospital Anxiety and Depression Scale), AQLQ (Asthma Quality of Life Questionnaire). RESULTS: No group differences in baseline expectancy. Statistically significant results (P < 0.05) indicated that at follow-up, F2FB participants perceived greater need for a physiotherapist than DVD and booklet participants (3.43 (0.87) versus 2.15 (1.26)). F2FB participants reported greater enjoyment of core techniques (such as stomach breathing: 7.42 (1.67) versus 6.13 (1.99) (DVD and booklet)). Fewer F2FB participants reported problems due to doubts (24 (22.9%) versus 90 (54.2%)). F2FB participants completed more practice sessions (75.01 (46.38) versus 48.56 (44.71)). Amount of practice was not significantly related to quality of life. In the DVD and booklet arm, greater confidence in breathing retraining ability explained 3.9% of variance in quality of life at 12 months. CONCLUSION: Adults with asthma receiving breathing retraining face-to-face report greater enjoyment and undertaking more practice than those receiving a DVD and booklet. Greater confidence in ability to do breathing retraining is associated with improved QoL.

A Framework for Analyzing and Measuring Usage and Engagement Data (AMUsED) in Digital Interventions: Viewpoint.

Trials of digital interventions can yield extensive, in-depth usage data, yet usage analyses tend to focus on broad descriptive summaries of how an intervention has been used by the whole sample. This paper proposes a novel framework to guide systematic, fine-grained usage analyses that better enables understanding of how an intervention works, when, and for whom. The framework comprises three stages to assist in the following: (1) familiarization with the intervention and its relationship to the captured data, (2) identification of meaningful measures of usage and specifying research questions to guide systematic analyses of usage data, and (3) preparation of datasheets and consideration of available analytical methods with which to examine the data. The framework can be applied to inform data capture during the development of a digital intervention and/or in the analysis of data after the completion of an evaluation trial. We will demonstrate how the framework shaped preparation and aided efficient data capture for a digital intervention to lower transmission of cold and flu viruses in the home, as well as how it informed a systematic, in-depth analysis of usage data collected from a separate digital intervention designed to promote self-management of colds and flu. The Analyzing and Measuring Usage and Engagement Data (AMUsED) framework guides systematic and efficient in-depth usage analyses that will support standardized reporting with transparent and replicable findings. These detailed findings may also enable examination of what constitutes effective engagement with particular interventions.

Addressing unmet needs in understanding asthma mechanisms: From the European Asthma Research and Innovation Partnership (EARIP) Work Package (WP)2 collaborators.

Asthma is a heterogeneous, complex disease with clinical phenotypes that incorporate persistent symptoms and acute exacerbations. It affects many millions of Europeans throughout their education and working lives and puts a heavy cost on European productivity. There is a wide spectrum of disease severity and control. Therapeutic advances have been slow despite greater understanding of basic mechanisms and the lack of satisfactory preventative and disease modifying management for asthma constitutes a significant unmet clinical need. Preventing, treating and ultimately curing asthma requires co-ordinated research and innovation across Europe. The European Asthma Research and Innovation Partnership (EARIP) is an FP7-funded programme which has taken a co-ordinated and integrated approach to analysing the future of asthma research and development. This report aims to identify the mechanistic areas in which investment is required to bring about significant improvements in asthma outcomes.

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.

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).

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.

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.

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.