Although important learnings come from traditionally designed large prospective asthma cohorts, highly restrictive inclusion and exclusion criteria limit generalisability to clinical practice. Moreover, small sample sizes for important disease subtypes, narrow scope of clinical data collection and limited biomarker assessments reduce the power of some studies to detect important and diverse longitudinal disease courses. The Real-world and Genomic data-based Asthma Insights through Network Analysis (REGAIN) study takes a novel approach to asthma cohort development by employing a pragmatic definition of asthma and simplified study procedures for biospecimen and data collection. REGAIN will produce a large scale, real-world, longitudinal clinical and molecular description of asthma powered to characterise and compare clinically relevant asthma subtypes. This design will provide insights on distinct longitudinal trajectories of disease, predictors of response to therapies and likelihood of clinical remission, all of which should help guide asthma management.

REGAIN is a clinical observational retrospective and prospective cohort study designed to determine large scale, real-world longitudinal clinical and molecular descriptions of asthma according to types of treatment, level of asthma control and inflammatory biology based on clinical biomarkers. Key questions include predictors of change in asthma control as well as timing and durability of clinical remission on biological therapy. To complement these clinical insights, REGAIN will produce one of the largest multiscale data sets in asthma that will include demographic and clinical features, inflammatory biomarkers, responses to therapy with inhaled steroids and other inhaled controllers with or without asthma biologics, and serial airway epithelium and peripheral blood transcriptomics and proteomics. REGAIN targets enrolment of 780 participants with asthma fitting one of five prespecified asthma subtypes with the aim of better characterising under-studied groups and allowing comparative analyses to elucidate important differential therapeutic responses and clinical trajectories. We target enrolment of 400 healthy controls to provide a healthy state molecular description of the tissues sampled in REGAIN participants with asthma. Participants with asthma are followed prospectively for 18 months with assessment of longitudinal clinical status including prospective clinical data collection, integration of electronic medical record data and serial biospecimen collection at 6 and 18 months. Participants with asthma starting treatment with asthma biologics undergo additional clinical assessment and biospecimen sampling at 3 months to track early clinical and molecular response to therapy. Healthy participants without asthma are evaluated cross-sectionally on enrolment without longitudinal follow-up in order to compare molecular profiles for airway epithelium and blood. An optional study component for participants with asthma employs a mobile phone application, digital inhaler monitors and home digital peak flow measurements and contributes data on real-time medication use, serial lung function and geolocated environmental data relevant to asthma.

The REGAIN protocol and all amendments were approved by The Icahn School of Medicine at Mount Sinai Program for Protection of Human Subjects (PPHS19-0358), and all participants provided written informed consent. Enrolment began in November 2019 and was completed in February 2024. Results will be presented at local, national and international meetings, and results will be submitted to peer-reviewed journals for consideration for publication.

NCT06623435.

Individuals experiencing moderate to severe mental illness have low rates of workforce inclusion, with a consequence of high welfare dependency, affecting both societal costs and health. Individual Placement and Support (IPS) is an approach to supported employment where the goal is to help people obtain jobs on the open rather than sheltered labour markets. Despite multiple randomised controlled trials (RCTs) indicating that the IPS model enables employment better than treatment as usual, with widespread adoption in some jurisdictions, the broader impacts of this large-scale implementation on mental health, quality of life and social functioning remain unknown.

Between 2012 and 2019, Norway introduced IPS through both local and national government projects. This study assesses the social and economic benefits of the implementation of IPS using Norwegian registry data, focusing on 18–45-year-old people receiving specialist mental healthcare, and who did not have steady employment at treatment start. Instead of assessing IPS efficacy in an RCT design, we use a naturalistic study design, evaluating IPS effectiveness by comparing aggregate population-level outcomes over time between areas where IPS was not available.

In work package (WP) 1, we mapped the availability and implementation of IPS across Norway. This involved analysing information on funding, resource and capacity levels to understand how IPS had been rolled out across the country. While completed, we include a description of WP1 here, as it informs WP2 and WP3. WP2 is an effectiveness evaluation investigating the population-level outcomes of implementing IPS, focusing on health, mortality, quality of life and social functioning. Finally, in WP3, we assess the financial implications of implementing IPS from a public purse perspective, synthesising data on resource use and costs of implementation with data from WP2.

Overall, we will examine the societal effects of IPS implementation on employment, welfare dependency, mental healthcare use, emergency care visits, self-harm and suicide, general mortality, crime and victimisation. Emphasis will be on long-term outcomes, and we will model the economic consequences of IPS. This study aims to inform policy making and strategies for implementing IPS at scale.

This is an effectiveness study using registry data. The Regional Committee for Medical Research Ethics Northern Norway, REK North has approved the use of registry data without informed consent for this project (approval number 134553).

The findings will be disseminated both in academic peer-reviewed journals, directly to informants in WP1, to the public through media and the project website, and at relevant conferences and seminars for specific relevant target groups.

Not applicable

Antimicrobial resistance is one of the biggest threats posed to healthcare systems, accounting for hundreds of thousands of deaths worldwide and correlated with poorer health status and increased healthcare costs. The practice of delayed prescription seems to be an effective solution to diminish the unnecessary overprescription of antibiotics, as study results demonstrated that it does not negatively affect health status while engaging patients and addressing their desire for a prescription when visiting the doctor’s office. This study investigates the point of view of family doctors practising in Switzerland, a country where delayed prescription has not yet been introduced. The main scope was to describe the perceived barriers and facilitators towards delayed prescription of antibiotics.

A total of five online focus group discussions.

Family medicine.

21 family doctors practising in the Italian-speaking region of Switzerland (M=51.24; SD=9.73 years of age; 62% males).

Focus group discussions revealed a generally negative attitude towards delayed antibiotic prescription among participants. Thematic analysis identified three key themes reflecting perceived barriers to its implementation: (1) Maintenance of authority through a gatekeeping role, highlighting concerns about preserving professional control over treatment decisions; (2) Importance of maintaining communication, addressing fears that delayed prescription could undermine clarity and trust in doctor–patient interactions and (3) Healthcare system and guidelines for good practice, which encompasses structural and normative expectations around follow-up visits, pre-existing practices and clinical routines. These themes illustrate the multifaceted nature of physicians’ resistance to adopting delayed prescription in their daily practice.

An additional information that emerged from the discussions is the extensive use in the region of a practice similar to delayed prescription, called ‘the stock antibiotic’. However, it is perceived very differently by physicians because it does not enforce a predetermined waiting time on patients.

Past research has demonstrated that delayed prescription is an effective practice for reducing antibiotic consumption and promoting patients’ empowerment while maintaining their satisfaction. Nevertheless, the results of this study show that doctors’ perceptions of this practice are not always positive. Any attempt to introduce the practice should start with a careful evaluation of the cultural context and doctors’ opinions, as their willingness to embrace the practice is crucial for its successful adoption. A more practical implication of our results stems from the discovery of the practice of the stock antibiotic, which could be described as a new version of delayed prescription, tailored to the customs and practices of the region. This aspect highlights the importance of exploring local contexts to ensure that prescribing practices can be implemented in alignment with local preferences.