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Cohort Multiple Randomised Trials COHORT MULTIPLE RANDOMISED TRIALS A plan to address the research priorities identified by the James Lind Alliance Priority Setting Partnership in Adult Cardiac Surgery. Funded by In partnership with SCTS Society for Cardiothoracic Surgery in Great Britain and Ireland UNIVERSITY OF LEICESTER UNIVERSITY OF LEICESTER FOREWORD UK cardiovascular research is world leading in terms of quality and impact. This is attributable to our unique NIHR research infrastructure and funding that makes the NHS the best environment in the world to undertake clinical research, combined with over £100m per year from the British Heart Foundation, the world’s largest funder of research into cardiovascular disease. Cardiac surgery in the UK has the capacity to deliver world class clinical research, and has produced many pivotal trials over the last 5-10 years. However, as a specialty, cardiac surgery is undergoing a period of transition, with increasingly elderly and frail patients referred for surgery, and the continuous development of new less invasive techniques and devices. Continuing to deliver the best personalised care to patients in these circumstances requires high quality evidence based on research. The research environment is also changing; clinical research is now undertaken by interdisciplinary teams of professionals with diverse skills. Important questions are also often best addressed by national and international networks of researchers. Patients and the public must also be central to all our research activities. This report describes an approach to cardiac surgery research that will address the changing environment, capitalise on our unique research infrastructure, and result in the best care for our patients. First, we will focus our endeavours on the questions that matter most to patients and clinicians. Patients must be at the centre of our research, and continue as partners and advocates through the lifetime of the research programme. Second, we will come together as a specialty to undertake high quality research in every UK cardiac centre. This research must be interdisciplinary and of the highest quality. Third, we must develop a cohort of young researchers, both trainee surgeons as well as nurses and allied health professionals, who will emerge as research leaders within the next decade. Finally we must create lean, pragmatic research platforms that are attractive to industry partners to enable accelerated technology transfer and device evaluation, as these represent the future of our specialty. This report we hope will form the basis for a conversation that will enable all stakeholders to contribute to the process, and ensure that we can translate CONTENTS our research priorities into a research programme that will lead to better care for patients. 3 FOREWORD 4 A NATIONAL CLINICAL TRIALS PROGRAMME IN ADULT CARDIAC SURGERY 5 PROJECT MILESTONES 6 THE TOP TEN PRIORITIES FOR ADULT CARDIAC SURGERY RESEARCH 8 ADDRESSING RESEARCH PRIORITIES USING A COHORT MULTIPLE RCT DESIGN Professor Gavin Murphy, BHF Chair of Cardiac Surgery 12 FORMULATING RESEARCH QUESTIONS 16 BIBLIOGRAPHY 17 NEXT STEPS 18 ACKNOWLEDGEMENTS AND DISCLAIMER 2 3 UNIVERSITY OF LEICESTER A NATIONAL CLINICAL PROJECT TRIALS PROGRAMME IN MILESTONES ADULT CARDIAC SURGERY RATIONALE IMPLEMENTATION THE NEXT 10 YEARS Patients undergoing cardiac surgery in the Infrastructure: In 2017, the BHF The UK presents a unique environment for United Kingdom benefit from the highest established a clinical trials funding clinical research and innovation in cardiac quality care. However, as a discipline, committee with an emphasis on the surgery that will benefit patients and the FEBRUARY 2017 cardiac surgery faces multiple challenges. delivery of large pragmatic trials. In NHS. The next step is to develop a platform Patients referred for cardiac surgery are addition, in 2018, the BHF also established that can deliver a portfolio of clinical British Heart Foundation identifies the need to develop increasingly elderly, often with multiple a new Clinical Research Collaborative to trials that address the national research a consensus around clinical research priorities. chronic conditions, and require more coordinate interdisciplinary multicentre priorities. complex surgery than historical cohorts. trials in cardiovascular disease. NOVEMBER 2017 In addition, new and potentially better Heart Research UK funds the Heart Surgery National Priority Setting: In 2017, diagnostic tests, less invasive treatments, Priority Setting Partnership (PSP). Heart Research UK funded the James and devices, are being introduced into Lind Alliance Priority Setting Partnership MARCH 2018 clinical care at an accelerating rate. The in Adult Cardiac Surgery. This identified best way to adapt to these challenges, and Launch of First PSP Survey at Society for the Top 10 research priorities for patients, to maintain the highest standards of care Cardiothoracic Surgeons (SCTS) in the UK carers and clinicians. These priorities have for patients, is through research. It is only and Ireland Annual Meeting, Glasgow. been converted to research questions that through the generation of high quality @heartsurgerypsp Twitter account launched. can be answered by clinical trials evidence that we will be able to direct the JUNE 2018 (see below). best care, to the individual patient, at the Cochrane Heart Group joins the right time. Academic training: In 2017, the Society Priority Setting Partnership for Cardiothoracic Surgery in Great Britain STRATEGY and Ireland, along with the Royal College of Surgeons of England’s Clinical Trials In 2017, the British Heart Foundation Initiative funded the training of junior NOVEMBER 2018 Workshop for Cardiovascular Surgery surgeons in clinical trial methodology and First Survey closes. 1080 questions submitted Research identified priority areas for the establishment of an Interdisciplinary by 629 participants. Duration was 9 months, development: Research Network of Associate Principal DECEMBER 2018 averaging 70 participants per month. 1. The need for investment in clinical Investigators in every UK cardiothoracic trials research infrastructure. centre. These initiatives will, we hope, Literature review, duplicate questions combined, nurture next generation of research already-addressed questions removed. 2. The development of a portfolio of leaders. 49 unanswered summary questions identified. pragmatic trials based on a national priority setting process. Partnerships: Accelerated technology transfer and strategic partnerships with 3. The need for investment in industry are embedded in the 2018 Life MARCH 2019 academic training. Sciences Sector Deal. Cardiovascular Second Survey launched at SCTS Annual 4. The development of strategic surgery is characterised by rapid Meeting, Westminster, London. partnerships with industry and technological advancement and universities to facilitate technology innovation and represents an area JUNE 2019 for further growth in industry funded transfer and the rapid evaluation Second Survey closes. 492 participants. evaluation of percutaneous and of devices. Questions narrowed down to 21 summary questions. minimally invasive techniques. JULY 2019 Final Workshop, attended by patient, carer and clinician representatives at Leicester. TOP 10 PRIORITISED QUESTIONS 4 5 UNIVERSITY OF LEICESTER THE TOP TEN PRIORITIES FOR ADULT CARDIAC SURGERY RESEARCH 1 2 3 4 5 QUALITY OF LIFE FRAILTY CHRONIC CONDITIONS PREHABILITATION HEART VALVE INTERVENTION How does a patient’s quality of life How can we address frailty and How can we improve the outcomes Does prehabilitation (a programme When should heart valve intervention (QOL) change (e.g. disability-free improve the management of frail of heart surgery patients with of nutritional, exercise and occur for patients without symptoms? survival) following heart surgery patients in heart surgery? chronic conditions (obesity, psychological interventions before and what factors are associated diabetes, hypertension, renal failure, surgery) benefit heart surgery with this? autoimmune diseases etc.)? patients? 6 7 8 9 10 SURGICAL METHODS ORGAN DAMAGE 3D BIO-PRINTING ATRIAL FIBRILLATION INFECTION How does minimally invasive heart How do we minimise damage to Can we use 3D bio-printing or stem What are the most effective ways How do we reduce and manage surgery compare to traditional organs from the heart-lung machine/ cell technology to create living tissues of preventing and treating post- infections after heart surgery open surgery? heart surgery (heart, kidney, lung, (heart valves/heart) and repair failing operative atrial fibrillation? including surgical site/sternal wound brain and gut)? hearts (myocardial regeneration)? infection and pneumonia? 6 7 UNIVERSITY OF LEICESTER ADDRESSING RESEARCH PRIORITIES USING A COHORT MULTIPLE RCT DESIGN WHAT: WHY: HOW: COCHRANE COLLABORATION Cohort Multiple RCTs recruit participants This approach combines the advantages of Cochrane Heart will commission a to a longitudinal cohort study with long- traditional RCTs (high quality evidence) and ESTABLISH THE UK CARDIAC series of systematic reviews to address term follow-up, preferably using routinely registry data sources (lean, efficient design) SURGERY TRIALS COHORT the research questions generated by collected healthcare data. The cohort and is particularly suited to pragmatic trials. A consecutive cohort of adult cardiac the Priority Setting Partnership. These also serves to identify those patients who surgery patients in every UK unit who will will
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