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.

Post-traumatic stress disorder (PTSD) constitutes a significant anxiety disorder that exerts substantial societal and familial impacts, while concurrently imposing an additional as well as a substantial burden on the healthcare system. Beyond the direct expenses incurred in its treatment, PTSD also gives rise to broader economic costs. The details of these costs in the UK are currently, we believe, unknown.

Our methodology was developed collaboratively with a collaborative advisory group of clinicians, patients, carers and other stakeholders. A comprehensive search strategy was devised to identify articles, including systematic reviews evaluating the economic costs linked to PTSD. We adhered to the National Institute for Health and Care Excellence checklist for economic evaluations. After applying our search strategy, the selected included papers were analysed to identify various cost categories contributing to the economic burden of PTSD.

PubMed, PsycInfo, PTSDpubs, EMBASE and Google Scholar were searched from January 1990 until January 2023; the search was revised and re-run in September 2024.

The articles must have been published originally in English and include a detailed evaluation of costs related to PTSD.

Two independent reviewers used standardised methods to search, screen and code included papers. After applying our search strategy, selected included papers were analysed to identify various cost categories contributing to the economic burden of PTSD. Detailed information on per-contact and per-session costs of healthcare variables was obtained at 2020/2021 prices. Additionally, with the advisory group, we ensured the validity of frequencies and unit cost figures associated with variables linked to PTSD. Further, indirect socio-economic costs arising from PTSD were computed.

By extrapolating from cost components identified, our findings indicate an average annual cost exceeding £14 780 per person. Given current 2020/2021 prevalence rates, this translates to an annual societal burden of £40 billion, a figure that does not encompass the many additional financial burdens stemming from PTSD, such as poor or inconsistent employment. This figure does not include the myriad intangible costs ranging from reduced quality of life to suicidality and countless other issues a person may suffer from as a result of PTSD. Finally, this number does not capture the breadth of impact, as it is difficult to quantify how the families, communities and social systems are adversely affected (both financially and otherwise) by the condition.

The economic and societal burden of PTSD in the UK is far greater than what extant research and common understanding indicate, as there is minimal awareness and information relating to indirect costs or ancillary effects such as discrimination, joblessness, substance use and other comorbidities. Ultimately, we found that there exists, conservatively, an annual excess societal burden of £40 billion, or approximately £14 780 per person. We demonstrated that PTSD is a significantly larger burden on society and individuals than estimated and that we are gravely underquantifying the cost of this increasingly prevalent condition.