Research and Development (R&D) 2014/2015 Annual Report Research is a core activity at Papworth Hospital. The Trust continues to invest to support research of the highest quality and is working closely with the University of Cambridge to design and build what will be UK’s leading Cardio-respiratory Research Institute. The institute will see Papworth and University Researchers working side-by-side to allow fully translational research from bench to bedside. Recruitment and Research Activity The number of patients receiving relevant health services provided or sub-contracted by Papworth Hospital in 2014/15 that were recruited during that period to participate in research approved by a research ethics committee was 4,051. See table below: Type of research project NIHR portfolio studies Non-NIHR portfolio studies No. of participants recruited per financial year 2011/12 2012/13 2013/14 2014/15 1,037 2,645 1,363 1,175 366 899 633 367 Tissue bank studies* 1,966 1,719 (1,991) 1,245 (1,450) 2,509 (2,675) Total 3,369 5,262 3,241 4,051 Figures collected from local audit and correct as of 05/05/2015 NIHR = National Institute for Health Research *Tissue bank studies: include two studies registered on the NIHR portfolio. Total figure given in brackets to avoid double counting as participants are included in the NIHR portfolio total. During 2014/15 we enrolled 4,051 patients across a balanced portfolio of 65 studies that were open to recruitment with 55% of these studies being interventional (testing of new therapies and treatments) vs. 45% observational in design. The 65 studies we recruited into comprised of 24% being commercially sponsored research, 32% Papworth Hospital sponsored research and 44% being sponsored by other leading NHS Trusts and academic institutions within the UK. In addition to this recruitment activity we completed follow up visits on research participants for an additional 60 studies. The drop in recruitment compared to 2013/14 was reflected across hospitals around the region. Papworth was the top recruiting site in the UK for 30% of the multicentre NIHR portfolio studies we supported. In addition, it was the 2nd highest recruiting NHS Trust per percentage of patient population within the East of England for NIHR portfolio research in 2014/15. Top recruiting studies include Victory (Prospective, randomised, controlled investigation comparing the safety and performance of 032-11 Surgical Haemostat 2g Applicator with FLOSEAL® Haemostatic Matrix as an adjunctive haemostat in cardiac surgery and thoracic aortic surgery) and Absorb UK (ABSORB UK Registry A post-market registry of patients with de novo lesions in previously untreated vessels treated with Absorb BVS). The Department has worked hard to improve processes within the department and with the clinical teams. This is resulting in faster approval times for studies and an increase in studies recruiting to time and target. The Unit is strengthening the team with the introduction of a senior data manager role and a quality manager. The introduction of a training post ‘Clinical Research Assistants’ has made a significant difference to the running of trials within the department, with the studies supported by these posts being highly successful. These achievements mark Papworth as an excellent place for conducting clinical research ensuring our patients and clinicians get the opportunity and access to the latest research therapies and treatments. Over the past 12 months our Trials Unit have adopted their first non-Papworth sponsored study (MARS2 - A study to determine if it is feasible to recruit into a randomised trial comparing (extended) pleurectomy decortication versus no pleurectomy decortication in the multimodality management of patients with malignant pleural mesothelioma, sponsored by the Royal Brompton and Harefield NHS Foundation Trust) which opened to recruitment in April 2015. Highlights The “Optimisation of the perfusate and environment required for reanimation and assessment of the Donation after Circulatory Determined Death (DCD) donor heart.” (DCD Study) being led by Consultant Cardiothoracic Surgeon Mr Stephen Large led directly to the first successful recipient of a heart transplant from a non-heart beating donor in Europe. This was following a substantial amount of research over a number of years. A Papworth Hospital pump priming award awarded to Dr A Klein to identify the causes of anaemia and association with outcome in cardiac surgical patients was published in Heart in 2015. They have subsequently formed a collaborative group with UCL (London), Cardiff and Bristol to apply for a major grant for a follow-up study in this area. In addition, following up from the results of this study they have set up an anaemia clinic at Papworth for cardiac surgery patients. After securing external funding in 2012/13 from the British Lung Foundation, MesobanK (a tissue bank collecting samples from mesothelioma patients) has been collecting samples from patients around the UK. Following robust quality control of samples the tissue bank is now accepting applications from researchers worldwide. Research Impact and Publications Over 301 papers, Cochrane reviews and book chapters with Papworth authors were published during 2014 and in 2015 to date across a breadth of clinical disciplines. Of these, 101 articles were published in journals with impact factor of 5 or more. One example of Papworth’s research impact can be seen in the conclusion of the TOMADO trial: Quinnell TG, Bennett M, Jordan J, et al. A crossover randomised controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea (TOMADO). Thorax. [Comparative Study Randomized Controlled Trial Research Support, Non-U.S. Gov't]. 2014 Oct;69(10):938-45. The study showed that nonadjustable oral mandibular advancement devices achieve clinically important improvements in mild to moderate obstructive sleep apnoea-hypopnoea syndrome and are cost-effective. Of the devices trialled, the semi-bespoke device was shown to be an appropriate first choice. The Trust remains committed to improving patient outcomes by undertaking clinical research that will lead to better treatments in the NHS. We would like to say thank you to all those who participated in our research over the past year.