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Treatment Outcomes in Epilepsy

Summary of the impact

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:

  • Triggered NICE guidelines update (2012), underpinning guidance on management of first seizures, new epilepsy, women with epilepsy
  • Changes to drug labelling (SPC) for sodium valproate (2011)
  • Informed guidance in other countries (e.g. German guidelines, International League Against Epilepsy Guidelines; US Medicine guidelines)
  • Underpinned UK and EU policy on driving following first seizures and antiepileptic drug withdrawal

Submitting Institution

University of Liverpool

Unit of Assessment

Public Health, Health Services and Primary Care

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Neurosciences

Impact of research into selection bias and ethical issues on published medical guidelines and legal judgements

Summary of the impact

Professor Hutton's research considers the biasing effect of selection of data due to consent procedures or selective reporting, and its consequences for the validity of conclusions and reliability of results. This research has had impacts on patients directly; on health and legal professionals by informing and influencing national and international guidelines for the treatment of epilepsy used by healthcare professionals and practitioners; and has provided expert evidence to legal professionals for the conclusion of civil litigations and a General Medical Council professional misconduct trial. Hutton's research also informs ethical debate associated with the validity and robustness of study results. This work has determined guidelines for ethical conduct of research, and requirements for publications, which are significant for all biomedical researchers.

Submitting Institution

University of Warwick

Unit of Assessment

Mathematical Sciences

Summary Impact Type

Health

Research Subject Area(s)

Mathematical Sciences: Statistics

2. Cardiff-led research underpins new UK and International clinical treatment guidelines for the management of acquired haemophilia A

Summary of the impact

A Cardiff researcher has led an International 15 year programme resulting in multiple novel findings which have led to changes in the recommended diagnosis and treatment of acquired haemophilia A (AHA). The research has, for the first time, allowed the comparison of immunosuppressive regimens for inhibitor eradication and comparison of the efficacy of treatment strategies to control bleeds. Studies led directly to the production of UK and International guidelines on the management of AHA with 14 of the 18 specific recommendations in the UK guideline being underpinned by Cardiff-led research.

Submitting Institution

Cardiff University

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services

Multi-country risk-mapping leads to more efficient delivery of mass-treatment for the control of river blindness

Summary of the impact

Onchocerciasis (river blindness) is a debilitating disease of major public health importance in the wet tropics. The African Programme for Onchocerciasis Control (APOC) seeks to control or eliminate the disease in 19 countries. Accurate mapping of Loiasis (eye-worm) was a requirement for implementation of APOC's mass-treatment prophylactic medication programme in order to mitigate against serious adverse reactions to the Onchocerciasis medication in areas also highly endemic for Loiasis. Model-based geostatistical methods developed at Lancaster were used to obtain the required maps and contributed to a change in practice of APOC in a major health programme in Africa. Our maps are used to plan the delivery of the mass-treatment programme to rural communities throughout the APOC countries, an estimated total population of 115 million.

Submitting Institution

Lancaster University

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Health

Research Subject Area(s)

Mathematical Sciences: Statistics
Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Public Health and Health Services

Development of novel adaptive designs to improve efficiency in clinical trials

Summary of the impact

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.

Submitting Institution

University of Reading

Unit of Assessment

Mathematical Sciences

Summary Impact Type

Political

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Oncology and Carcinogenesis, Pharmacology and Pharmaceutical Sciences

2. Policies for Better Treatment for Employees with Disabilities and Long-term Health Problems

Summary of the impact

This research into treatment for employees with disabilities provides one of the UK's Equality Performance Indicators and recommendations from it have been incorporated into UK legislation. Hundreds of organisations have used the research to promote better treatment for employees with disabilities; public-sector employers, including government departments, have relied on it to meet their statutory duties and it has helped the UK to fulfil its international treaty and convention obligations in respect of people with disabilities. This research has helped the Equality and Human Rights Commission (EHRC) to fulfil its statutory role to promote equality and human rights.

Submitting Institution

Cardiff University

Unit of Assessment

Sociology

Summary Impact Type

Societal

Research Subject Area(s)

Medical and Health Sciences: Public Health and Health Services
Commerce, Management, Tourism and Services: Business and Management
Psychology and Cognitive Sciences: Psychology

Patients, organisations providing clinical guidelines, and commercial companies benefit from new approach to comparing multiple healthcare options

Summary of the impact

Patients are more likely to get the most effective healthcare, at affordable cost to the NHS, as a result of research methodology, developed by researchers at the University of Bristol, that allows the efficacy and cost-effectiveness of multiple treatment options to be compared, based on all the available evidence, much more efficiently than in the past. Since 2008, these methods have been used to inform Clinical Guidelines issued by the National Institute for Health and Care Excellence (NICE) and in submissions to NICE's Technology Appraisals. Guidance in NICE's Technology Appraisals is mandatory and therefore impacts directly on clinical practice. The methodology is used in decision making by NICE's equivalents in other countries including Canada, Germany, and South Korea, and by consultancy firms that conduct analyses for pharmaceutical companies.

Submitting Institution

University of Bristol

Unit of Assessment

Public Health, Health Services and Primary Care

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Public Health and Health Services
Economics: Applied Economics

Preventing the gastroduodenal hazards of non-steroidal anti-inflammatory drugs and aspirin through widespread adoption of proton pump inhibitors

Summary of the impact

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.

Submitting Institution

University of Nottingham

Unit of Assessment

Clinical Medicine

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Clinical Sciences, Pharmacology and Pharmaceutical Sciences

Inhaled therapies

Summary of the impact

Research by the University of Huddersfield's School of Applied Sciences has played a major role in addressing the difficulties experienced by people who use inhalers. The work has adapted existing methodologies so they can mimic how patients use nebulisers and dry powder inhalers, thereby enhancing understanding of a problem that affects millions globally. Findings and insights have been incorporated in "gold standard" guidelines that are influencing practice and policy around the world, while lead researcher Professor Henry Chrystyn's methods and techniques have become central to academic, practitioner and industry efforts to tackle the issue at national and international level.

Submitting Institution

University of Huddersfield

Unit of Assessment

Allied Health Professions, Dentistry, Nursing and Pharmacy

Summary Impact Type

Health

Research Subject Area(s)

Medical and Health Sciences: Cardiorespiratory Medicine and Haematology, Pharmacology and Pharmaceutical Sciences

Improving Clinical Trials by Innovative Statistical Design

Summary of the impact

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:

  • faster results: making effective new treatments available sooner; also, stopping negative trials early avoids exposing patients to ineffective treatments and releases resources for new studies;
  • smaller sample sizes: average reductions of 20-30% are possible in sequential trials;
  • the ability to modify trial conditions while retaining statistical validity: this flexibility can accelerate the drug development process by months or even years.

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).

Submitting Institution

University of Bath

Unit of Assessment

Mathematical Sciences

Summary Impact Type

Health

Research Subject Area(s)

Mathematical Sciences: Statistics
Medical and Health Sciences: Public Health and Health Services
Economics: Applied Economics

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