Aims: ‘Flow’ is a transcranial direct current stimulation (tDCS) treatment for depression that patients use at home. Meta-analyses of randomised sham-controlled trials (RCTs) show tDCS is safe, easy to use, and associated with significant improvements in depressive symptoms and high rates of clinical response and remission relative to placebo sham stimulation. Flow is BSI and CE-marked for treating depression in the UK, with NICE guidance for use in the NHS. Flow incorporates an evidence backed healthy lifestyle behaviour training software app, and depression symptom tracking that enables users and their clinicians to monitor progress/symptoms. Training modules on: ‘Behaviour activation’, ‘Mindfulness’, ‘Exercise for your brain’, ‘An anti-depression diet’, and ‘Therapeutic sleep’. In a first for the NHS, Northamptonshire Healthcare NHS Foundation Trust’s (NHFT) Specialist Perinatal Mental Health and Maternal Loss Psychology Service offered Flow to their patients with a diagnosis of depression and evaluated the feasibility and impact. Methods: The patient self-administers Flow tDCS treatment, sessions last for 30 minutes, and are repeated 5 times weekly for 3 weeks, and after the initial 3-week period, patients self-administer 3 sessions per week for 3 weeks, and then as long as required. Outcome measure data collection from baseline to 6-week follow-up point. Self-report measures used were depression: Personal Health Questionnaire (PHQ-9); health related quality of life: EQ-5D-5L; and real-world functioning: Work and Social Adjustment Scale (WSAS). In-depth interviews were undertaken with 14 patients. Results: There has been high level of adherence in the 25 participants to treatment protocol. There has been statistically significant improvements in depression symptoms (large effect size), real-world meaningful functioning, and health-related quality of life. Reliable improvement and remission rates for PHQ-9 were 64% and 52% respectively. In in-depth interviews most participants described a positive impact on depressive symptoms, sleep, social life, and functioning. Conclusion: Flow has been successfully integrated into Perinatal Mental Health and Maternal Loss Psychology Service depression treatment offer. It is important to offer NHS patients an evidence-backed alternative to existing depression treatments (antidepressant medication and talking therapies), many patients stop antidepressants when they become pregnant, and many do not tolerate antidepressants side effects or wish to try due to side effects and withdrawal issues. Findings provide support for the approach of delivering both tDCS and on-line wellbeing behaviour therapy training to patients with experience of depression.
Abstract Background Households in areas of socio-economic deprivation are more likely to consume diets low in fruit and vegetables. Fresh Street is a place-based fruit and vegetable voucher scheme with vouchers redeemable with local independent (non-supermarket) vendors. Paper vouchers are offered to all households in a geographical area regardless of household type, size, or income with no requirement to demonstrate need. The regular shareable vouchers are combined with recipes and dietary information to increase exposure to healthy food prompts, reduce food insecurity, increase fruit and vegetable consumption, improve dietary quality, and support healthy dietary habits. This study aimed to inform a randomised controlled trial (RCT) to assess the impact of Fresh Street on a range of public health outcomes. Methods The pilot cluster RCT took place in three inner city areas of high socioeconomic deprivation in England (Tower Hamlets, Bradford, and Doncaster). New systems for managing vouchers and doorstep delivering weekly envelopes to households were developed. Weekly envelopes containing vouchers (5 x £1), a healthy seasonal recipe and brief nutritional information were offered to all households in nine intervention streets. Nine control streets received no intervention. Household surveys collected information on fruit and vegetable consumption, diet quality, and household characteristics. Results The household survey response rate was below the 50% target for progression to the main trial. Most local fruit and vegetable vendors accepted vouchers. Three quarters or more of households regularly accepted the envelopes. The scheme was well received by households, local vendors and local public health teams. Household uptake of the scheme was highest in Tower Hamlets (75%) and Bradford (83%). The mean weekly voucher redemption was highest in Tower Hamlets (£3.26) and Bradford (£2.82), where the scheme ran longest, and where vendors were nearby. Conclusions This was the first pilot RCT of a place-based, household voucher approach. The newly developed system for securely printing and redeeming the vouchers worked well and is potentially scalable. Future trials should consider alternative methods of assessing the impact on households and explore more efficient ways to deliver the intervention e.g. through collaborative working with local resources such as community centres.
BackgroundAmong 5.4 million people receiving treatment for asthma in the United Kingdom, more than 2 million experience suboptimal control, leading to the use of health care services and resulting costs as well as poorer quality of life. Online health communities (OHCs) are increasingly used as a source of lay health advice, providing opportunities for learning and mutual support and complementing information from “official” health sources. While engagement with OHCs has the potential to improve self-management, concerns remain about the reliability and usefulness of the information posted. Professional moderation of such communities is essential for supporting sensitive patients, ensuring adherence to forum guidelines, and maintaining clinical safety. ObjectiveThis study aims to examine the experiences of moderators in an asthma OHC, identifying challenges and possible areas to optimize the safety and effectiveness of patient engagement. MethodsAll 6 current moderators of a nationwide charity-hosted OHC participated in in-depth, semistructured, audio-recorded, remote interviews. Audio recordings were transcribed verbatim and qualitatively analyzed using reflexive inductive thematic analysis. ResultsThe 6 moderators interviewed comprised 4 (67%) specialist respiratory nurses, 1 (17%) volunteer patient ambassador, and 1 (17%) customer support manager (all female, with average age 45, SD 10.5 y). In total, 5 (83%) moderators had at least a year’s experience of OHC moderation. Three main themes were generated from data analysis: moderation processes, challenges to effective moderation, and OHC effectiveness. The first theme focused on the different moderator roles and tasks undertaken, including the application of OHC guidelines in dealing with inappropriate content. The second theme covered difficult issues, such as mental health, and practical challenges, including lack of time and concerns about missing problematic posts. The third theme focused on the factors that made the OHC effective and increased its effectiveness, including keeping users safe, generating more OHC activity, encouraging discussion, and raising awareness of the OHC. We found a contradiction in how the moderators perceived the OHC’s effectiveness and their role in moderating it. While they expressed concerns about having insufficient time to moderate the OHC, they also felt that it was underused and would be more effective if it were busier or more active. ConclusionsBuilding on the challenges experienced by the moderators, several recommendations were put forward to optimize the safety and effectiveness of the asthma OHC. Moderators often work in isolation without external training or interaction with others. More research into OHC moderation is needed. A continuous professional development framework could improve moderation quality and user support, aligning with the evolving needs of these communities. These results can be relevant to national and international policy, attempting to enhance the safety of patients’ engagement with OHCs.
The relationship between indoor air quality and public health remains under-researched. WellHome is a transdisciplinary community-based study that will engage with residents to co-design feasible and acceptable research to quantify air pollution exposure in 100 homes in West London and examine its potential to exacerbate asthma symptoms in children. Sampling strategies such as using air quality monitors and passive samplers placed in kitchens, children’s bedrooms, and living rooms, will be developed in collaboration with local ambassadors and participating households to measure multiple physical, chemical, microplastic, and biological contaminants. This will provide a comprehensive understanding of indoor air quality across the city’s socio-economic gradient. Other data collected will include housing types and tenure, ventilation practices, occupant behaviours, time-activity, and airway symptoms. Epidemiological analysis will examine air pollution exposure impacts on children’s respiratory health. The particulate mixture’s relative hazard will be evaluated in toxicity studies based on source profiles and activity patterns of participants, focusing on asthma exacerbation related pathways. The study’s findings will be communicated to participants through co-designed reports and inform evidence-based recommendations for reducing indoor air pollution in London and urban areas worldwide. By raising awareness and providing actionable insights, WellHome seeks to contribute to global efforts to improve the health and well-being of vulnerable communities.
BACKGROUND:A 2021 meta-analysis of 37 randomised controlled trials (RCTs) of vitamin D supplementation for prevention of acute respiratory infections (ARIs) revealed a statistically significant protective effect of the intervention (odds ratio [OR] 0·92 [95% CI 0·86 to 0·99]). Since then, six eligible RCTs have been completed, including one large trial (n=15 804). We aimed to re-examine the link between vitamin D supplementation and prevention of ARIs. METHODS:Updated systematic review and meta-analysis of data from RCTs of vitamin D for ARI prevention using a random effects model. Subgroup analyses were done to determine whether effects of vitamin D on risk of ARI varied according to baseline 25-hydroxyvitamin D (25[OH]D) concentration, dosing regimen, or age. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Web of Science, and the ClinicalTrials.gov between May 1, 2020 (end-date of search of our previous meta-analysis) and April 30, 2024. No language restrictions were imposed. Double-blind RCTs supplementing vitamin D for any duration, with placebo or lower-dose vitamin D control, were eligible if approved by a Research Ethics Committee and if ARI incidence was collected prospectively and pre-specified as an efficacy outcome. Aggregate data, stratified by baseline 25(OH)D concentration and age, were obtained from study authors. The study was registered with PROSPERO (no. CRD42024527191). FINDINGS:We identified six new RCTs (19 337 participants). Data were obtained for 16 085 (83·2%) participants in three new RCTs and combined with data from 48 488 participants in 43 RCTs identified in our previous meta-analysis. For the primary comparison of any vitamin D versus placebo, the intervention did not statistically significantly affect overall ARI risk (OR 0·94 [95% CI 0·88-1·00], p=0·057; 40 studies; 61 589 participants; I2=26·4%). Pre-specified subgroup analysis did not reveal evidence of effect modification by age, baseline vitamin D status, dosing frequency, or dose size. Vitamin D did not influence the proportion of participants experiencing at least one serious adverse event (OR 0·96 [95% CI 0·90-1·04]; 38 studies; I2=0·0%). A funnel plot showed left-sided asymmetry (p=0·0020, Egger's test). INTERPRETATION:This updated meta-analysis yielded a similar point estimate for the overall effect of vitamin D supplementation on ARI risk to that obtained previously, but the 95% CI for this effect estimate now includes 1·00, indicating no statistically significant protection. FUNDING:None.
INTRODUCTION:Under-vaccination among underserved groups remains low due to existing disparities. This is particularly the case with postpandemic COVID-19 vaccinations and other vaccine-preventable diseases, including measles, mumps, rubella or influenza. Therefore, we aim to (1) determine the feasibility and practicality of implementing a patient engagement tool (PET) and gain vital insights to plan a subsequent definitive randomised controlled trial (RCT) to evaluate the effectiveness of this tool for increasing uptake of COVID-19 and influenza vaccinations and (2) define the appropriate level of support needed for healthcare providers at site-level to ensure successful implementation of the PET and to identify supporting activities needed to implement interventions for COVID-19 and influenza vaccinations. METHODS AND ANALYSIS:This is a randomised controlled feasibility study evaluating a co-designed PET, involving randomisation at individual and cluster levels. For individual randomisation, patients will be individually randomised 1:1 to receive the intervention (PET) or routine care; whereas for cluster randomisation, six GP (General Practitioner) practices will be randomised 1:1 and divided into two tranches at two separate time points. Both groups will receive training and software activation. Data will be analysed using statistical software R (V.4.0 or greater) or STATA (V.17 or greater). Baseline characteristics will be summarised and presented in groups based on an intention-to-treat basis with categorical data, including demographics, socioeconomic variables, comorbidities and vaccination status. ETHICS AND DISSEMINATION:Ethical approval was granted by the Westminster Ethics Committee (ref: 316860). Our dissemination strategy targets three audiences: (1) policy makers, public and health service managers, and clinicians responsible for delivering vaccines and infection prevention services; (2) patients and public from underserved population groups and (3) academics. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov (NCT05866237).
Background:Migrants are at increased risk of chronic infections and have poorer outcomes, being more likely to present late. Early diagnosis and management can reduce morbidity, mortality and onward infection transmission. Methods:We evaluated the effectiveness of an integrated approach to screening migrants for exposure to tuberculosis (TB) with an interferon gamma release assay (IGRA) test, HIV, hepatitis B virus (HBV, using hepatitis B surface antigen testing) and hepatitis C virus (HCV, using antibody testing with confirmatory PCR test) infection when patients first registered with general practices (GPs) in Leicester, UK, using test yields (test positivity rates), numbers of new diagnoses and numbers linked to care. Findings:Of 4004 migrant GP patients referred for testing 2016-2019, test yields were 0.48% (17/3545, 95% CI 0.30-0.77%, HIV), 3.34% (117/3502, 95% CI 2.80-3.99%, HBV), 0.18% (6/3402, 95% CI 0.08-0.38%, HCV) and 19.38% (496/2560, 95% CI 17.89-20.95%, IGRA). Of IGRA-positive patients attending clinic, 7% (31/437) had active TB and 92% (403/437) had latent TB infection. Seventeen (55%) active TB, 397 (99%) latent TB, 71 (61%) HBV, six (35%) HIV and five (83%) HCV infections were new diagnoses. There were high rates of linkage to care for those newly diagnosed. 98% (390/397) of new latent TB patients were offered chemoprophylaxis, of whom 94% (366/390) started treatment and of these, 95% (346/366) completed the course. 100% (6/6), 97% (69/71) and 100% (5/5) of newly HIV-, HBV- and HCV-diagnosed patients attended follow-up, respectively. Interpretation:This first primary care-based combined infection testing programme for recent migrants found high test yields for latent/active TB, HBV and HIV, substantial numbers of new diagnoses for these infections and excellent linkage to care. To influence UK screening guidelines, its cost-effectiveness and acceptability to other primary care settings must be evaluated. Funding:NIHR, Gilead Sciences.
BACKGROUND:Guidelines recommend Emergency Department (ED) healthcare professionals (HCPs) ensure patients have a supply of inhaled corticosteroid on discharge after an acute asthma presentation. By optimising medication, acute asthma presentations to EDs are a potentially reachable moment to improve long-term asthma management as well as treating the acute exacerbation. Optimising medication for long-term asthma management requires behavioural changes from HCPs, which may be considered unacceptable or unfeasible. Understanding health beliefs and attitudes of HCPs who provide asthma treatment in emergency care is a critical step in determining whether interventions could be developed to address this. AIMS:To explore the health beliefs, attitudes and behaviours of HCPs involved in the care of adult patients presenting to the ED with asthma. METHODS:UK HCPs, purposively sampled for profession, experience and work setting, were invited to participate in a semi-structured face-to-face or online interview. These were conducted between November 2021 and June 2022. Eligible participants had experience of caring for patients with asthma in either the ED or primary care setting. Interviews were analysed with reflective thematic analysis. RESULTS:19 HCPs were interviewed. Four themes were identified, constructed around the beliefs and behaviours of HCPs: (1) Compassionate understanding, that is, recognising the accessibility of ED, patients' self-management and the emotional aspects of exacerbations, (2) Doing what is right for the patient, that is, maximising a reachable moment, (3) Tensions of capacity in the system, that is, acknowledging workload within ED and (4) ED as providers of preventative care. CONCLUSION:This study found HCPs recognise both the accessibility of the ED as a place for patients to seek help and that there are potential opportunities to optimise asthma control, but there are barriers to overcome. ED professionals may be willing to make changes in the best interests of the patients if they can follow guidelines and receive training.
Background Emergency department (ED) attendances with acute asthma are an opportunity for simple medication changes to improve long-term self-management, but patients’ beliefs and behaviours need to be considered for interventions to be successful. We explored the health beliefs and behaviours of adult patients who have presented to the ED with asthma and considered their attitudes to ED-based interventions designed to improve long-term asthma control.Methods 19 semi-structured face-to-face or online patient interviews were conducted in 2021/2022. Eligible participants were patients over age 16 who had attended and were discharged from the ED with an asthma exacerbation. Purposive sampling was undertaken to ensure representation of patients of different ages, ethnicity and gender. Interviews were analysed with reflective thematic analysis.Results Themes that reflected the beliefs and behaviours of the patients were: (1) experiences of an asthma exacerbation—the emotional response and self-management during an episode; (2) discharge dilemma—expectations and communication on discharge from ED, impacted by time, language and capacity in the acute environment; (3) do what is best for me—openness to change such as of medication, if rationale and support is provided; and (4) perceptions of asthma medication—reliance on salbutamol, concerns about inhaled corticosteroids, openness to maintenance and reliever therapy inhalers and device preferences.Conclusion Patients do not expect longer-term care to be provided in the ED. However, patients trust healthcare professionals to recommend appropriate treatment and are willing to accept a change in medication or inhaler device in this context.
Aims: The study evaluates the use of transcranial direct current stimulation (tDCS) via a portable device, called Flow FL-100 , within Community Mental Health Services (CMHT) for patients with depression. This service targets individuals who either did not benefit from medication or sought alternatives to it. Flow is a tDCS treatment for depression that patients can use at home. It is safe, well-tolerated, and free from the side effects commonly associated with antidepressants. Backed by over 30 years of research, tDCS has shown significant improvements in depressive symptoms, with high clinical response rates. Recent studies show remission rates of up to 45% with Flow. The treatment is CE-marked for use in Europe, and a recent NICE briefing (2023) highlights its efficacy and safety. The evaluation also references positive results from randomised controlled trials (RCTs), showing Flow leads to better outcomes than placebo stimulation. Methods: This service evaluation assessed the use of tDCS for treating depression in Community Mental Health Teams (CMHT) for patients who hadn’t responded well to medication or wanted an alternative. After a clinical interview and assessment, eligible patients were offered the treatment. Outcome data was collected at baseline and again after 6 weeks, using the Montgomery– Åsberg Depression Rating Scale (MADRS). The treatment involved patients self-administering tDCS for 30 minutes, five times a week for three weeks, then three times a week for three more weeks, with option of continuing as needed. The “Flow” system also includes a lifestyle training app and symptom tracking, allowing patients and clinicians to monitor progress online. The study used an open-label design without a control group, with 20 participants (12 males, 8 females), of whom 16 shared their progress on the online platform and were included in the analysis. Results: We analysed 16 data sets, which showed the following Results: the average MADRS score at the initial assessment was 32. By week 6, 82% (12/16) of participants had improved on the MADRS scale, with 44% (7/16) demonstrating clinically significant improvement, marked by a reduction of more than 25% in their MADRS score. Conclusion: These results indicate that tDCS portable device “Flow” treatment is a promising and valuable intervention for treating depression in adults in CMHT service.
Background We evaluated the impact of three successive COVID-19 national lockdowns in England and Wales on the referrals from general practice (GP) to the Identification and Referral to Improve Safety domestic violence and abuse (DVA) services.Methods Anonymised data on daily referrals, interrupted-time series and non-linear regression quantified the impact of the three national lockdowns over 2020 and 2021 comparing analogous periods in the 2 years before and after, reporting incidence rate ratios, 95% CIs and p values. Time spent at home and workplace visits over the lockdown periods were quantified as proxies for the stringency of the different lockdowns.Results The first national lockdown in early 2020 led to a reduced number of referrals to DVA services (32%, 95% CI 16% to 45%). Over the second and the third lockdown, there was a possible increase in the number of referrals: 29%, 95% CI -4% to 73% and 12%, 95% CI -10% to 39%, respectively. The first national lockdown was more stringent (58% decline in workplace visits; 22% increase in time spent at home) than the second (34% decline in workplace visits; 14% increase in time spent at home) or the third (18% decline in workplace visits; 18% increase in time spent at home).Conclusions Increased freedom of movement alongside easier access to GP services during the two latter, less stringent, lockdowns compared with the first, stringent, lockdown could have contributed to the different trends in referrals. We highlight that ensuring access to primary care and adequate and continuing provision of specialist support for people experiencing DVA is important during national emergencies.
Randomised controlled trials (RCTs) are widely regarded as the most powerful research design for evidence-based practice. However, recruiting to RCTs can be challenging resulting in heightened costs and delays in research completion and implementation. Enabling successful recruitment is crucial in mental health research. Despite the increase in the use of remote recruitment strategies and digital health interventions, there is limited evidence on methods to improve recruitment to remotely delivered mental health trials. The paper outlines practical examples and recommendations on how to successfully recruit participants to remotely delivered mental health trials. The Alpha Stim-D Trial was a multi-centre double-blind randomised controlled trial, for people aged 16 years upwards, addressing depressive symptoms in primary care. Despite a 6-month delay in beginning recruitment due to the COVID-19 pandemic, the trial met the recruitment target within the timeframe and achieved high retention rates. Several strategies were implemented to improve recruitment; some of these were adapted in response to the COVID-19 pandemic. This included adapting the original in-person recruitment strategies. Subsequently, systematic recruitment using postal invitations from criteria-specific search of the sites’ electronic health records was added to opportunistic recruitment to increase referrals in response to sub-target recruitment whilst also reducing the burden on referring sites. Throughout the recruitment process, the research team collaborated with key stakeholders, such as primary care clinicians and the project’s Patient and Public Involvement and Engagement (PPI/E) representatives, who gave advice on recruitment strategies. Furthermore, the study researchers played a key role in communicating with participants and building rapport from study introduction to data collection. Our findings suggest that trial processes can influence recruitment; therefore, consideration and a regular review of the recruitment figures and strategies is important. Recruitment of participants can be maximised by utilising remote approaches, which reduce the burden and amount of time required by referring sites and allow the research team to reach more participants whilst providing participants and researchers with more flexibility. Effectively communicating and working collaboratively with key stakeholders throughout the trial process, as well as building rapport with participants, may also improve recruitment rates.
Background: Flow FL-100 is a self-administered transcranial direct current stimulation (tDCS) device used in combination with a software application delivered well-being behaviour therapy training, which has evidence of effectiveness in treating symptoms of depression. In this study, the combined Flow FL-100 and well-being behaviour therapy training app, an intervention known as “Flow”, was offered by a participant’s general practitioner (GP) in a United Kingdom (UK) primary care setting to those who experienced depressive symptoms. Participants completed six weeks of use of Flow. This study explored participants’ experiences and views on the feasibility, acceptability, useability, and value of Flow. Methods: A qualitative approach was employed, involving in-depth semi-structured interviews. Thematic and content analyses were applied. Out of a sample of 47 participants using Flow, 18 participants consented to be interviewed. The age range of the participants was 23 - 75 years (M = 52.78, SD = 16.27); 10 (55.6%) were female and 8 (44.4%) male. Results: There was support for the feasibility, acceptability, useability and value of combined Flow FL-100 and well-being behaviour therapy training. Most participants described a positive impact on depressive symptoms, sleep, and functioning. Findings provide support for the approach of delivering together both tDCS and evidence-backed well-being behaviour therapy training. Conclusion: Flow has been successfully integrated into a primary care service depression treatment. It is important to offer patients an evidence-based alternative to existing depression treatments (anti-depressant medication and talking therapies). The results support the use of Flow as a treatment option for people with symptoms of depression.