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A team at the University of Liverpool has undertaken research that has informed practice and policy worldwide in the management of patients presenting with newly diagnosed epilepsy, which has achieved international impact on health. Seizures are common and 3-5% of the population will be given a diagnosis of epilepsy during their lifetime. Decisions about when to start treatment, and if so with which drug are crucial and can have a significant effect on outcomes for the individual and have significant economic consequences for society. The research includes the undertaking and analysis of data from randomised controlled trials. The data analysis is based on the statistical research initiated by Dr Paula Williamson while in the Department of Mathematical Sciences at the University of Liverpool between 1996 and 2000. The research identified the most appropriate first line treatments for patients with newly diagnosed epilepsy, addressing both clinical and cost effectiveness. This work has underpinned national policy and triggered the most recent update of the NICE (National Institute for Clinical Excellence) epilepsy guidelines in 2012.
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.
Clinical trials form a crucial step in translating fundamental medical research into improved healthcare. Many hundreds of trials are conducted every year, each involving hundreds, sometimes thousands, of patients. These trials are expensive, with costs as high as 20 or 30 thousand pounds per patient. Research in Bath on group sequential monitoring and the adaptive design of clinical trials has improved the conduct of clinical trials, leading to:
The impact of this research is economic (the business performance of pharmaceutical companies and businesses that support them), societal (by enhancing public health and by changing the policies adopted by regulators) and ethical (ensuring clinical trials remain safe, while bringing life-saving treatments into clinical use as rapidly as possible).
Professor Hutton has applied her research on statistical models for survival analysis to cerebral palsy, a neurological disorder which afflicts around 1 in 500 of newborn children globally. The body of research has established medically-accepted norms for the life expectancy of people with cerebral palsy. Her research extends to the study of life expectancy for patients suffering from spinal cord injuries.
The impact of this work has been internationally substantial, influencing medical and legal professionals, and informing lay people with involvement in cerebral palsy. Her work is also widely cited by patient-networks and textbooks.
Hutton is regularly called by both defence and plaintiff lawyers, as an expert witness worldwide, assessing life expectancy for damages arising from negligence in obstetric or paediatric care, or from accidents. Her expertise is also used in brain and spinal cord injury cases, which also result in substantial awards. The award of appropriate damages in legal cases ensures that patients receive the best care for the rest of their lives. From Jan 2008 to July 2013 Hutton has provided expert evidence in 103 such cases around the world, which had impact on decisions about compensation totalling in the range £100M-450M.
Cardiovascular disease is a major worldwide health issue and cholesterol has long been recognised as an important risk factor. The Robertson Centre for Biostatistics (RCB), led by Prof. Ian Ford, has played a central role in establishing for the first time the benefits of statins in preventing first-time heart attacks in men, with subsequent major influence on medical practice and guidelines for patient care. Innovative record linkage techniques used by the RCB have identified the long-term benefits of treatment, confirmed safety, and quantified the economic benefits.
Patients in clinical trials tend to have a very high drop-out rate which compromises results. Research by Sarah Edwards provided the key ethical framework for limiting individual choice in designing research involving human subjects. Edwards' research, showing how such designs can legitimately limit individual choices to withdraw, was incorporated into guidelines in the UK, Canada and the US, and by international bodies such as the World Health Organisation. In the UK, the research was also used to develop guidelines for ethics committees approving controlled trials.
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.
The epilepsy research group at the University of Liverpool (UoL) has undertaken a programme of work assessing treatment outcomes associated with antiepileptic drug treatment in patients with epilepsy. This includes two large pragmatic trials in patients with first seizures and newly diagnosed epilepsy, and cohort studies assessing malformations and cognitive development in children exposed to antiepileptic drugs in utero, and the work of the Cochrane Epilepsy Group.
This work has influenced prescribing in the UK and worldwide through the following impacts:
Research at Strathclyde has brought about a change in eye surgery practice throughout Europe and worldwide. A four-year cross-Europe study in collaboration with the European Society of Cataract and Refractive Surgery (ESCRS) investigated antibiotic treatment to prevent endophthalmitis, a complication arising during cataract operations which typically results in loss of sight. The findings showed that when the treatment is given at the start of surgery it leads to a 5-fold reduction in the risk of endophthalmitis. The European Society of Cataract and Refractive Surgery has endorsed the discovery and widely promoted the uptake of the treatment through publications and guidelines, which over the last 6 years has led to the prevention of loss of sight in thousands of patients. In Europe alone it is estimated that each year there have been 7500 fewer cases of blindness following cataract surgery as a result of the ESCRS guidelines.