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Background: Insomnia is a prevalent and distressing sleep disorder. Multicomponent cognitive-behavioural therapy is the recommended first-line treatment, but access remains extremely limited, particularly in primary care where insomnia is managed. One principal component of cognitive-behavioural therapy is a behavioural treatment called sleep restriction therapy, which could potentially be delivered as a brief single-component intervention by generalists in primary care., Objectives: The primary objective of the Health-professional Administered Brief Insomnia Therapy trial was to establish whether nurse-delivered sleep restriction therapy in primary care improves insomnia relative to sleep hygiene. Secondary objectives were to establish whether nurse-delivered sleep restriction therapy was cost-effective, and to undertake a process evaluation to understand intervention delivery, fidelity and acceptability., Design: Pragmatic, multicentre, individually randomised, parallel-group, superiority trial with embedded process evaluation., Setting: National Health Service general practice in three regions of England., Participants: Adults aged ≥ 18 years with insomnia disorder were randomised using a validated web-based randomisation programme., Interventions: Participants in the intervention group were offered a brief four-session nurse-delivered behavioural treatment involving two in-person sessions and two by phone. Participants were supported to follow a prescribed sleep schedule with the aim of restricting and standardising time in bed. Participants were also provided with a sleep hygiene leaflet. The control group received the same sleep hygiene leaflet by e-mail or post. There was no restriction on usual care., Main Outcome Measures: Outcomes were assessed at 3, 6 and 12 months. Participants were included in the primary analysis if they contributed at least one post-randomisation outcome. The primary end point was self-reported insomnia severity with the Insomnia Severity Index at 6 months. Secondary outcomes were health-related and sleep-related quality of life, depressive symptoms, work productivity and activity impairment, self-reported and actigraphy-defined sleep, and hypnotic medication use. Cost-effectiveness was evaluated using the incremental cost per quality-adjusted life-year. For the process evaluation, semistructured interviews were carried out with participants, nurses and practice managers or general practitioners. Due to the nature of the intervention, both participants and nurses were aware of group allocation., Results: We recruited 642 participants ( n  = 321 for sleep restriction therapy; n  = 321 for sleep hygiene) between 29 August 2018 and 23 March 2020. Five hundred and eighty participants (90.3%) provided data at a minimum of one follow-up time point; 257 (80.1%) participants in the sleep restriction therapy arm and 291 (90.7%) participants in the sleep hygiene arm provided primary outcome data at 6 months. The estimated adjusted mean difference on the Insomnia Severity Index was -3.05 (95% confidence interval -3.83 to -2.28; p  < 0.001, Cohen's d  = -0.74), indicating that participants in the sleep restriction therapy arm [mean (standard deviation) Insomnia Severity Index = 10.9 (5.5)] reported lower insomnia severity compared to sleep hygiene [mean (standard deviation) Insomnia Severity Index = 13.9 (5.2)]. Large treatment effects were also found at 3 ( d  = -0.95) and 12 months ( d  = -0.72). Superiority of sleep restriction therapy over sleep hygiene was evident at 3, 6 and 12 months for self-reported sleep, mental health-related quality of life, depressive symptoms, work productivity impairment and sleep-related quality of life. Eight participants in each group experienced serious adverse events but none were judged to be related to the intervention. The incremental cost per quality-adjusted life-year gained was £2075.71, giving a 95.3% probability that the intervention is cost-effective at a cost-effectiveness threshold of £20,000. The process evaluation found that sleep restriction therapy was acceptable to both nurses and patients, and delivered with high fidelity., Limitations: While we recruited a clinical sample, 97% were of white ethnic background and 50% had a university degree, which may limit generalisability to the insomnia population in England., Conclusions: Brief nurse-delivered sleep restriction therapy in primary care is clinically effective for insomnia disorder, safe, and likely to be cost-effective., Future Work: Future work should examine the place of sleep restriction therapy in the insomnia treatment pathway, assess generalisability across diverse primary care patients with insomnia, and consider additional methods to enhance patient engagement with treatment., Trial Registration: This trial is registered as ISRCTN42499563., Funding: The award was funded by the National Institute of Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/84/01) and is published in full in Health Technology Assessment ; Vol. 28, No. 36. See the NIHR Funding and Awards website for further award information.

Background: Patients belonging to marginalised (medically under-served) groups experience problems with medicines (i.e. non-adherence, side effects) and poorer health outcomes largely due to inequitable access to healthcare (arising from poor governance, cultural exclusion etc.). In order to promote service equity and outcomes for patients, the focus of this paper is to explore the implementation and impact of a new co-produced digital educational intervention on one National Health Service (NHS) funded community pharmacy medicines management service., Methods: Semi-structured interviews with a total of 32 participants. This included a purposive sample of 22 community pharmacy professionals, (16 pharmacists and 6 pharmacy support staff) all who offered the medicine management service. In order to obtain a fuller picture of the barriers to learning, five professionals who were unable to complete the learning were also included. Ten patients (from a marginalised group) who had received the service (as a result of the digital educational intervention) were also interviewed. Drawing on an interpretative analysis, Normalisation Process Theory (NPT) was used as a theoretical framework., Results: Three themes are explored. The first is how the digital learning intervention was implemented and applied. Despite being well received, pharmacists found it challenging completing and cascading the learning due to organisational constraints (e.g. lack of time, workload). Using the four NPT constructs (coherence, cognitive participation, collective action and reflexive monitoring) the second theme exposes the impact of the learning and the organisational process of 'normalisation'. Professional reflective accounts revealed instances where inequitable access to health services were evident. Those completing the intervention felt more aware, capable and better equipped to engage with the needs of patients who were from a marginalised group. Operationally there was minimal structural change in service delivery constraining translation of learning to practice. The impact on patients, explored in our final theme, revealed that they experience significant disadvantage and problems with their medicines. The medication review was welcomed and the discussion with the pharmacist was helpful in addressing their medicine-related concerns., Conclusions: The co-produced digital educational intervention increases pharmacy professionals' awareness and motivation to engage with marginalised groups. However structural barriers often hindered translation into practice. Patients reported significant health and medicine challenges that were going unnoticed. They welcomed the additional support the medication review offered. Policy makers and employers should better enable and facilitate ways for pharmacy professionals to better engage with marginalised groups. The impact of the educational intervention on patients' health and medicines management could be substantial if supported and promoted effectively.

Objectives: People who are marginalised (medically underserved) experience significant health disparities and their voices are often 'seldom heard'. Interventions to improve professional awareness and engagement with these groups are urgently needed. This study uses a co-production approach to develop an online digital educational intervention in order to improve pharmacy staffs' intention to offer a community pharmacy medication review service to medically underserved groups., Design: Before/after (3 months) self-completion online questionnaire., Setting: Community pharmacies in the Nottinghamshire (England) geographical area., Participants: Community pharmacy staff., Intervention: Online digital educational intervention., Primary and Secondary Outcome Measures: The primary outcome measure was 'behaviour change intention' using a validated 12-item survey measure. The secondary outcome measure was pharmacist self-reported recruitment of underserved groups to the medication review service., Results: All pharmacies in the Nottinghamshire area (n=237) were approached in June 2017 and responses were received from 149 staff (from 122 pharmacies). At 3 months (after completing the baseline questionnaire), 96 participants (from 80 pharmacies) completed a follow-up questionnaire, of which two-thirds (n=62) reported completing the e-learning. A before/after comparison analysis found an improving trend in all the five constructs of behaviour change intention (intention, social influence, beliefs about capabilities, moral norms and beliefs about consequences), with a significant increase in mean score of participants' 'beliefs about capabilities' (0.44; 95% CI 0.11 to 0.76, p=0.009). In the short-term, no significant change was detected in the number of patients being offered and the patient completing a medication review., Conclusions: Although increases in the numbers of patients being offered a medication review was not detected, the intervention has the potential to significantly improve pharmacy professionals' 'beliefs about capabilities' in the short-term. Wider organisational and policy barriers to engagement with marginasied groups may need to be addressed. Future research should focus on the interplay between digital learning and practice to better identify and understand effective practice change pathways., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: This paper presents updated prevalence estimates of awareness, ever-use, and current use of nicotine vaping products (NVPs) from 14 International Tobacco Control Policy Evaluation Project (ITC Project) countries that have varying regulations governing NVP sales and marketing., Design, Setting, Participants and Measurements: A cross-sectional analysis of adult (≥ 18 years) current smokers and ex-smokers from 14 countries participating in the ITC Project. Data from the most recent survey questionnaire for each country were included, which spanned the period 2013-17. Countries were categorized into four groups based on regulations governing NVP sales and marketing (allowable or not), and level of enforcement (strict or weak where NVPs are not permitted to be sold): (1) most restrictive policies (MRPs), not legal to be sold or marketed with strict enforcement: Australia, Brazil, Uruguay; (2) restrictive policies (RPs), not approved for sale or marketing with weak enforcement: Canada, Malaysia, Mexico, New Zealand; (3) less restrictive policies (LRPs), legal to be sold and marketed with regulations: England, the Netherlands, Republic of Korea, United States; and (4) no regulatory policies (NRPs), Bangladesh, China, Zambia. Countries were also grouped by World Bank Income Classifications. Country-specific weighted logistic regression models estimated adjusted NVP prevalence estimates for: awareness, ever/current use, and frequency of use (daily versus non-daily)., Findings: NVP awareness and use were lowest in NRP countries. Generally, ever- and current use of NVPs were lower in MRP countries (ever-use = 7.1-48.9%; current use = 0.3-3.5%) relative to LRP countries (ever-use = 38.9-66.6%; current use = 5.5-17.2%) and RP countries (ever-use = 10.0-62.4%; current use = 1.4-15.5%). NVP use was highest among high-income countries, followed by upper-middle-income countries, and then by lower-middle-income countries., Conclusions: With a few exceptions, awareness and use of nicotine vaping products varied by the strength of national regulations governing nicotine vaping product sales/marketing, and by country income. In countries with no regulatory policies, use rates were very low, suggesting that there was little availability, marketing and/or interest in nicotine vaping products in these countries where smoking populations are predominantly poorer. The higher awareness and use of nicotine vaping products in high income countries with moderately (e.g. Canada, New Zealand) and less (e.g. England, United States) restrictive policies, is likely due to the greater availability and affordability of nicotine vaping products., (© 2019 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)