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Our research has shown that water softeners are not effective in reducing the symptoms of moderate to severe eczema in children, and that their use provides no additional benefit over usual care. This finding has had an impact on Healthcare practitioners ensuring they are now able to offer the evidence-based advice to patients that the use of water softeners will not alleviate the symptoms of eczema. This advice not only eliminates false hope in patient groups but also results in significant cost savings for families of children with moderate to severe eczema who might otherwise have purchased water softeners.
Atopic eczema is a disabling long-term skin condition affecting ~2% of the UK adult population. The mainstay of treatment remains topical steroids and moisturisers, but many adult patients with atopic eczema have resistant disease that can significantly impair quality of life. Newcastle University researchers conducted clinical trials that showed both whole-body ultraviolet B phototherapy and systemic (tablet) treatment with the immunosuppressant drug azathioprine were effective treatments for adults with atopic eczema resistant to standard topical treatments. UK and European guidelines written after 2008 recommend UVB phototherapy and azathioprine for atopic eczema, and survey data indicate that both are now widely used to treat the disease in the UK.
Research investigating genetic and environmental interactions leading to skin barrier breakdown in atopic eczema has delivered health benefits by improving the prevention and treatment of this condition. We found that established emollient formulations (e.g. Aqueous Cream BP) containing the harsh emulsifier sodium lauryl sulphate (SLS) damage the skin barrier in patients with atopic eczema and identified an underlying molecular mechanism. Consequently, the NICE Quality Standard and Guidelines now reflect our advice that Aqueous Cream should not be used as a leave-on emollient, SLS has been removed from all emollient formulations in the UK and we have helped develop the next generation of `SLS-free' skin-care products. Medicines regulators including the Medicines and Healthcare products Regulatory Agency (MHRA) and New Zealand MedSafe have also issued new advice as a result of our research.
Atopic eczema and associated conditions — asthma, food allergy and hay fever — affect ~40% of the population in developed nations. They cause significant morbidity and create a multibillion-pound global healthcare burden. The discovery that loss-of-function mutations in the gene encoding filaggrin represent a strong risk factor for eczema, asthma and peanut allergy has defined a key pathological mechanism in atopic disease. This breakthrough in understanding has brought new focus on the skin barrier. It has shown impact in treatment approaches to maintain barrier function, translational research targeting epithelial dysfunction and improved public and professional awareness of the role of skin in atopic disease.
Researchers at the University of Manchester (UoM) have made a significant impact nationally and internationally on improving the outcome for children with acute lymphoblastic leukaemia (ALL) (~450 pa in the UK). The changes in clinical practice based on our research are now national standards of care for children with de novo and relapsed ALL in the UK and Ireland. Other international groups have adopted key findings from the results of our frontline trials. Our relapse protocol for childhood ALL underpins European and North American strategy for the management of relapsed disease.
Prior to the change in WHO recommendations which occurred following this study many patients in Africa and other developing countries were receiving an inferior regimen for the management of tuberculosis, a consequence of which meant that many had to be retreated. Since the implementation of the revised WHO Guidelines in 2010 almost all countries have now switched to the gold standard tuberculosis treatment regimen based on 6 months of isoniazid and rifampicin
Dr Jeremy Howick's research into philosophical issues concerning the nature of the evidence invoked in evidence-based medicine has led both to a revision of the standards for reporting trials, and to a redesign of the Oxford Centre for Evidence-Based Medicine `Levels of Evidence': one of the most widely used systems for ranking medical evidence, and thereby for deciding whether treatments are effective, in the world. His research into philosophical issues concerning the ethics of using placebos in clinical trials and in clinical practice has influenced practitioners as well as patients by helping to determine how treatments are developed and applied. Through his research in both of these areas he has enhanced public understanding of the use of placebos.
Research on professionals' discussions about clinical trials of cancer therapy has identified the major barriers to patient recruitment to clinical trials. This research was used to create an educational intervention to improve patient experiences and willingness to participate in a variety of clinical trials worldwide, resulting in increased participation in prostate, colorectal, renal and breast-cancer trials. It also involved educating members of UK cancer teams to the best ways to approach, communicate and maximise trial planning.
Non-steroidal anti-inflammatory drugs (NSAIDs) are valuable analgesics, but cause dyspepsia, ulcers and hospitalisation (UK: 3,500pa, USA: 100,000pa) for complications that can lead to death (UK: 400-1,000pa, USA: 16,500pa). Acid inhibition by proton pump inhibitors (PPIs), the only widely accepted preventative strategy, was proposed and systematically proved by studies from Nottingham. NICE now recommends PPIs for all patients using NSAIDs and PPIs are central to all major international guidelines. PPI co-prescription has increased worldwide (from 27.6% in 2008 to 44.1% in 2012, in the UK); and reduces the risk of hospitalisation for gastrointestinal bleeding by 54% and symptomatic ulcer by 63%, thereby preventing up to 540 deaths per annum in the UK.
Clinical trials are costly to the pharmaceutical industry and public funding bodies, require major commitment from volunteer patients and take significant time to lead to patient benefit. Adaptive designs are one approach which seeks to improve the efficiency of such studies. Statistical research at Reading has led to novel methodology for the design and analysis of clinical drug trials within the framework of adaptive designs which has the potential to reduce the time taken for effective drugs to reach the market and thus benefit specific patient groups. To date the research has had impact in three major ways: i) it has been adopted by pharmaceutical companies as a means of improving the efficiency of their clinical trials, ii) the research has been cited in the regulatory guidance on adaptive clinical trial design, and iii) it has increased awareness by clinicians and other medical professionals of the potential benefit of the adaptive design methodology to their patient groups. Hence, the research has influenced industry, regulatory and health professionals with potential significant economic benefit and improved outcome for patients.