INNOVATIVE METHODS IN DIGITAL HEALTH

We will not only lead the world in understanding how to digitally transform health care, and how to derive new knowledge from health datasets, but we will also pioneer new methodological approaches in this field.  Our current work includes an innovative agile clinical trials platform built on routine electronic health records. This can radically improve current approaches to randomised trials and the evaluation of interventions, as well as long-term observational studies, at low cost, facilitating faster answers to deliver more rapid benefits to patients.   

Our work evaluating digital interventions considers new ways of assessing their usefulness, including the key issues of digital inclusion, and the green impact of digital approaches.  

The Oxford Primary Care Trials Unit (PC-CTU):

• has a portfolio of 10 trials on investigation of digital interventions primarily in mental health research, of which five completed and five are currently active.  Type of interventions include mobile apps, AI algorithm, devices, online intervention, or automated virtual reality.  Level of support varies from design, delivery, to analysis and dissemination.  In addition, CTU has also been using digital innovation and healthcare data to conduct two large decentralised platform design clinical trials from recruitment to data capture.
• Some of our most impactful studies include:
• The OASIS trial evaluated whether digital CBT, Sleepio, for insomnia reduced insomnia and reduced paranoia and hallucinations, compared with a usual practice control group.  Results of the trial has also contributed to the recommendation by NICE. 
• The gameChange trial evaluated a virtual reality (VR) based psychological therapy for people with severe mental health difficulties. Results of the trial has shown a significant reductions in the agoraphobic avoidance of everyday situations and distress.  The intervention has been recommended in a NICE Early Value Assessment for use in the NHS for patients diagnosed with psychosis who have severe agoraphobic avoidance.
• Both PRINCIPLE and PANORAMIC trials are two trials conducted during the pandemic that provides rapid initiation of multiple trials evaluating repurposed treatment and antivirals in the community, respectively.  Specially, PRINCIPLE trial has provided evidence that the two antibiotics, Azithromycin and Doxycycline, should not be recommended as treatments for COVID-19 infection.
• The CTU was recently awarded the Prix Galien Best Public Sector Innovation Award 2024 for the PRINICPLE and PANORAMIC trials.
• Recent publications:
• Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial.  Lancet. 2022
• PRINCIPLE Trial Collaborative Group. Doxycycline for community treatment of suspected COVID-19 in people at high risk of adverse outcomes in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial. Lancet Respir Med. 2021
• Azithromycin for community treatment of suspected COVID-19 in people at increased risk of an adverse clinical course in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial. Lancet. 2021
• Automated virtual reality therapy to treat agoraphobic avoidance and distress in patients with psychosis (gameChange): a multicentre, parallel-group, single-blind, randomised, controlled trial in England with mediation and moderation analyses. Lancet Psychiatry. 2022
• The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis.  Lancet Psychiatry. 2017

ORCHID

• The ORCHID research environment is hosted by the Nuffield Department of Primary Care Health Sciences .  ORCHID incorporates the Research Surveillance Centre which has been the primary source for disease surveillance in England for over 60 years.
• Nearly 2000 GP practices and around 19 million patients in England and Wales contribute pseudonymised data for national research and surveillance purposes. 
• ORCHID holds data from multiple UK clinical systems (e.g., EMIS and TPP) and which can link primary care data with other health data.
• ORCHID has the potential, with appropriate approvals, for linkage with pseudonymised secondary care e.g. HES, mortality and Cancer Registry data.  
• ORCHID consists of three research platforms:
• ORCHID Surveillance enables continuous monitoring of infections and diseases in the community .  It is the main source of information for UK Health Security Agency (UKHSA) and helps with prediction and management of flu outbreaks and pandemics. 
• ORCHID Epidemiology: a double pseudonymised, research database to facilitate well-designed epidemiological research, with a focus on primary care.  ORCHID-E may be used to develop feasibility and sample size calculations for the development and design of trials and other interventional studies.
• ORCHID Trials & Prospective is a future development that will to support our researchers in designing their trials and other interventional studies. As the database is nationally representative, our researchers are able to determine appropriate participant populations by checking feasibility of recruitment, sample size calculations taking into account the inclusion and exclusion criteria.  This platform will allow for targeted recruitment of study participants and support long-term follow-up studies in a more efficient, less burdensome and more cost effective way that traditional methods allow.