Sally spencer
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Sally Spencer's presentation from when she spoke at the conference on Friday 16th September
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Sally spencer
- 1. A retrospective on health research and the nature of collaboration Prof Sally Spencer Director of Research, Postgraduate Medical Institute, Edge Hill University Editor: Cochrane Dementia & Cognitive Improvement Group Cochrane Airways Group
- 3. edgehill.ac.uk Aims to: - Lead innovation in professional education; - Develop applied research to drive evidence-informed care; - Provide a partnership forum for enterprise and innovation Cross-faculty, interdisciplinary, partnership focused
- 5. edgehill.ac.uk Medicine MMed Surgery MCh * Dental Education MSc Dental Implantology * Assisted Conception MSc Advanced Fertility Practice MSc Clinical Reproductive Medicine Medical Leadership MSc Medical Leadership (Contract with HEE for North West) Medical and Clinical Education MA Clinical Education PGCert Teaching and Learning in Clinical Practice PGCert Simulation and Clinical Learning PGCert Workplace-based Postgraduate Medical Education Postgraduate Education
- 6. edgehill.ac.uk • NIHR Internship (funded) • MRes - Clinical and Health Research • PhD Graduate Teaching Assistants (FT student stipend) Part-time study • Full-time and part-time RA’s Research
- 7. edgehill.ac.uk • Relevant and responsive • Commissioned work • Collaborative research • Funding • Internal • External Research
- 8. The research journey • First impressions • What have we learned? • Advice
- 9. Who am I? • Bethlem Royal Hospital • St George’s Hospital • Worked with a range of professionals across primary & secondary care, third sector, local government and industry • Generated research income £3million + • Led establishment of a cross-sectoral collaborative research consortium at Lancaster (10 partners) • Research: QoL in clinical trials and systematic review (Cochrane) University of London Kingston University Brunel University Lancaster University Edge Hill University
- 11. Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease (COPD): the ISOLDE trial Study Protocol 990 eligible pts 8-week run-in period 239 withdrew 751 randomised 500g FP 2*day via MDI & spacer 375 Placebo 212 completed 175 completed 376 FP 3-yr dble-blind 3-yr dble-blind 164 withdrew 200 withdrew
- 12. My first ‘trial’ • Joined as a research assistant • Patient-focused outcome measures: SGRQ, SF36, SIP, MRC dyspnoea • Approx 10,0000 questionnaires over 3 years, generating over 338,000 datapoints
- 13. My first ‘trial’ • What was it like? • Data presentations, analyses, conferences • Scary, enlightening and exciting
- 14. My first ‘trial’ – the worst bits Speaking at my first conference: American Thoracic Society, attendance 15,000, audience 500
- 15. My first ‘trial’ – the best bits • Acquiring new skills: statistical modelling • Meeting new people: US, Europe, Australia • Building confidence • Publications: BMJ, AJRCCM, Chest, Thorax, etc • PhD: Role and analysis of QoL in trials And……………………………..
- 16. Adventure!
- 17. But did it make any difference? • Impact on research? • Impact on practice? • Impact on patients?
- 18. The Research Cycle Evidence Evaluation Research Design Research Evaluation Research Synthesis Practice Guidelines Early 90’s – evidence of effectiveness in asthma. ISOLDE : ICS v placebo AJRCCM, 2000 Lung Health Studies (US) & CCLS (EU) → Cochrane Review, 2002 What about COPD? GOLD, 2003 NICE (2004) ATS/ERS (2004)
- 19. What have we learned about doing health research?
- 20. Be determined to succeed • Passionate people make it happen • How to get your foot on the research ladder? – acquire research skills – develop unfunded research and publish the results – join a research team to gain experience
- 21. Start from the right place • What is the evidence base, i.e. has it been done? • What is the problem? • What is the solution? • Will it have an impact beyond your own frame of reference?
- 22. Collaboration – know what you don’t know • Few research projects are led by 1 person • Research funders expect multi-disciplinary teams – NHS - Commissioners – Academia - Service users – Industry - Research infrastructure – Voluntary sector
- 23. Manage expectations • Academics, clinicians, businesses • Roles and responsibilities? • Time scale? • Manage ego’s to avoid misunderstandings…
- 24. Oct 1995, radio conversation between US Navy and Canadian authorities off the coast of Newfoundland. Canadians: Please divert your course 15 degrees to the South to avoid a collision Americans: Recommend you divert your course 15 degrees to the North to avoid a collision Canadians: Negative. You will have to divert your course 15 degrees to the South to avoid a collision Americans: This is the Captain of a US navy ship. I say again, divert YOUR course! Canadians: No. I say again, divert your course.
- 25. Americans: THIS IS THE AIRCRAFT CARRIER USS LINCOLN, THE LARGEST SHIP IN THE US ATLANTIC FLEET, ACCOMPANIED BY 3 DESTROYERS, 3 CRUISERS AND NUMEROUS SUPPORT VESSELS. I DEMAND THAT YOU CHANGE YOUR COURSE 15 DEGREES NORTH OR COUNTER MEASURES WILL BE UNDERTAKEN TO ENSURE THE SAFETY OF THIS SHIP!!! Canadians: This is a lighthouse. Your call.
- 26. Regulations and process can be confusing. Seek help from: - Trust R&D - HEI R&D - NW Research Design Service - NIHR Clinical Trials Units - Funders guidelines
- 27. Effective time management ….. Research clinic, Friday morning in July Me: How can I help? Clinician: (Hands over 2 A4 sheets). My consultant wants me to submit this project to RfPB for funding and I need help with the application Me: (Reads the sheets) Ok, the project might have potential but it needs a lot work. Which deadline are you aiming for? Clinician: Monday.
- 29. Be gutsy and determined! Some characteristics help…….
- 30. Lead you up a blind alley… or lead you into eureka sunshine Research can… or lead to lifelong friendships Can get you into a fight…
- 31. scare the pants off you…. and give your life purposegive you sleepless nights…. and be deeply rewarding Research can…
- 32. Be ambitious, but realistic! So, my advice is…
- 33. Keep an open mind. People are often more than they appear to be and…
- 34. develop networks with new friends and colleagues and…
- 35. Have fun! and…
- 36. …don’t forget the things that matter. and most of all…
Editor's Notes
- I’d like to start by telling you a bit about Edge Hill University and the Postgraduate Medical Institute. The main campus is based at Ormskirk, about 10 mins from the M58 and the image is of the Faculty of Health and Social Care. We were named University of Year in 2014 by the Times Higher Education Awards, we are the best University in the North West for teaching excellence and student satisfaction according to the national student survey, and over recent years we have consistently ranked in the top 10 best University workplace awards. And we are growing, with more the £250 million pounds invested in campus expansion over the last ten years. We currently have over 17, 000 students , 4000 of those are postgraduate and we are increasing year on year.
- The Postgraduate Medical Institute was launched in 2014 and is based in the Faculty of Health and Social Care. The overall aim and reason for its inception, was to try and knit together the three factors that drive improved healthcare, namely teaching and education, applied research, and enterprise and innovation, more effectively in order to respond to the needs of a changing workforce, emerging changes in clinical practice and service delivery. In order to achieve this we recognised a need to encompass multiple perspectives that go beyond the medical and clinical disciplines normally associated with health research, such as sports science, computing science, social science, the humanities (English), management and business, amongst others. However, harnessing broad potential was only half the story and a key objective was to achieve our aims through working with external partners who have a stake in the development and delivery of high quality healthcare.
- Improvements in healthcare are underpinned by a process of professional lifelong learning, but healthcare education in the Higher Education sector tends to be rather disconnected from the daily business of delivering excellent care. Similarly the development and exploration of new ideas through research and innovation are often disconnected from the workforces they are designed to benefit. Not very surprising then that the transmission of new research ideas into clinical practice is hampered by scepticism and lack of uptake that spans a 10-15 year translation gap. So we aim to bring healthcare professionals into the development and delivery of postgraduate education, research and innovation to enable a research and education cycle that is relevant to the workforce and has a meaningful impact on care. We have begun to do this with some of our programmes, such as the Masters in Surgery, where professionals are taught in a framework that reflects and fits within working lives, emphasises the continuing nature of learning, and in particular engagement in research, and where graduating alumni return to contribute to the teaching of future students.
- We offer a range of postgraduate education programmes that have been developed in conjunction with external partners, and range from programmes on medical education, to assisted conception and medical leadership, with the latter supported by 3-year funding from Health Education England to support leadership across the North West, that was secured through competitive tender against Russell group Universities in the North. The Masters in Dental Implantology, the Masters in Medicine and the Masters in Surgery are unique to Edge Hill and delivered in partnership with external organisations as a blend of clinical content and research methods teaching. Students benefit from learning in blended cohorts where those from diverse professional backgrounds and courses receive core teaching, sharing individual experiences as part of the process.
- We support a range of research activities and particularly encourage students to view learning as a lifelong process embedded in career progression and professional advancement. We currently support students though internships funded by the National Institute for Health Research, that enable students to participate and engage in research projects, to get a feel for the practical business of doing research. They may then progress to undertake Masters in Research that provide skills training in research methods within the context of their own workplace. Students may also undertake significant programmes of research that will lead to a doctoral qualification. The University supports a graduate teaching associate programme that provides tuition fees and a 3-year stipend for students to undertake PhD’s on a full-time basis. This can be less attractive for working professionals, so we also offer part-time options for doctoral research and these are often self-funded or funded by the employee’s host institution. The PGMI supports a wide range of post-doctoral research assistants beginning their journey towards an academic career, and a range of honorary appointments for healthcare professionals who wish to remain in clinical practice and develop their own research interests.
- We support a range of research projects across the PGMI, with staff interests covering: children and young people, supporting care, professional education, and health and well-being, but these areas include academics from across the University, in different disciplines, as previously mentioned. We work in partnership with a number of external organisations, such as the Liverpool Women’s Hospital, Implant Centres of Excellence and the Royal College of Physicians, and we also work with other organisations such as Aintree Hospital and Alder Hey children’s hospital. We have a lively and active enterprise and innovation centre that supports projects across the region commissioned by local businesses, councils and Clinical Commissioning groups. Our funded research spans a range of sources including research funding councils, such as the NIHR and the ESRC on specific topics ranging from large-scale clinical trials, to exercise in school-children, evidence synthesis in respiratory disease, app development for patient self-management, and end of life care, using a range of qualitative, quantitative and mixed research methods. We are also fortunate that the University recognises the difficulties of developing early scoping work that may lead to substantial research bids, particularly in these times of austerity and financially hard-pressed clinical services, by provided internal funding streams to support the early stages of research development. There are three funding opportunities a year, each attracting a maximum of £25k per project and led by Edge Hill staff. Applications follows a similar competitive process to those used by the Research Funding Councils, but the emphasis is on collaborative working on projects likely to have demonstrable impact on communities outside of the University. There are therefore opportunities for keen clinical researchers to work with Edge Hill staff on projects that require pump-prime funding. So that’s Edge Hill and the PGMI in a nutshell.
- In the context of this conference the thing that brings us together is that we are all at various stages on a research journey, so I thought I would share some of my own journey with you and talk about some of the things I think I’ve learned along the way.
- But you might be thinking, why should you listen to me? So I’ll give you a snapshot of my pathway and you can decide for yourself. In the early part of my career I worked at the Bethlem Hospital, now part of the South London and Maudsley NHS Trust, and at St George’s Hospital in South London, on a range of clinical research projects – starting out as a research assistant and moving up to the role of Senior Research Fellow, before I joined the University of London. Edge Hill is now my fifth University post and I’ve held teaching and research roles in most of those places. I’ve been fairly successful in generating research income and in my earlier career this was predominantly from my involvement in clinical trials. I am still involved in clinical trials but also work closely with the Cochrane Collaboration on the development of evidence practice through systematic reviews. I’ve been very privileged to have worked with a range of professionals across the health care sector, including NHS consultants, nurses, physios, OT’s, speech and language therapists, public health specialists, statisticians, epidemiologists, NHS managers, charities, local government, the pharmaceutical industry, small businesses and so on. Before joining Edge Hill University I led the establishment of the Lancaster Health Hub, a collaborative research consortium that comprised Lancaster University and 3 NHS Trusts in the first instance, and when I left just over a year ago had grown to comprise 10-members including NHS Trusts, Clinical Commissioning Groups, Universities and a consumer organisation, with a multi-million pound track record of attracting research funding for cross-sectoral research projects. So, that’s me in a nutshell.
- So, what was it like at the start of the journey?
- This multi-centre clinical trial was one of the projects I became involved with as a postgraduate. (Read title). It trips off the tongue easily enough now, but I didn’t really understand a lot of it when I first joined the study. Essentially, it was a 3-year study looking at the impact of inhaled steroids on people with moderate to severe COPD who were recruited through 18 hospitals in the UK, and was funded by GSK, or Glaxo-Wellcome, as it was called then, before the merger with SmithKline Beecham. At that time, inhaled steroids had been shown to reduce exacerbation frequency in asthma (which is often characterised by hospital admission), which is a restrictive and reversible airways disease, but it’s impact on COPD, an inflammatory irreversible airways disease was unknown.
- I joined the study about a month into recruitment and was initially employed as a research assistant to manage all of the patient-focused outcome data. In those days it was all paper based questionnaires, self-completed by patients during trial clinic visits, and then sent to me for uploading into an electronic database alongside quality control and the management of missing data problems. There were 4 questionnaires, measured at various intervals over three years and, allowing for patients withdrawing from the study early, resulted in approximately 10,000 questionnaires, generating over 338,000 datapoints – and that was just the patient reported outcome measures! The trial as whole collected over 200 outcome variables from 751 patients at various points over 3 years, which is a lot of data. Sounds like an awful lot to manage and a lot of responsibility doesn’t it, but in actual fact, once I’d set up the databases and got the hang of it, it was pretty boring! And that’s where things began to change. I became interested in analysis of all the data, which was complex and challenging, and ultimately involved specialist training in advanced techniques as well as teaching myself to use an industrial statistical software package called SAS and learning how to write programming code for the analyses, as well as a highly specialist software package called MLWin and it’s relevant programming language. This in turn led to more responsibility as part of the trial team, more involvement in trial management meetings, a lot of liaison with GSK and their stats unit, more presentations at conferences, workshops and specialist meetings, and helping to write most of the main research papers.
- So, what was it like doing all of these things? Scary, because I was out of my comfort zone quite early on and thrust into unfamiliar environments. I had to defend my analyses, ideas and opinions within a group of highly experienced senior clinicians and pharmaceutical company personnel, and on occasion I had to do this alone when my boss, the consultant leading the PROM’s component for the trial, couldn’t make the meetings. Enlightening – to discover how trials worked in practice, how teams worked together and understanding the complexities of data collection, such as poor compliance. I remember a discussion about needing to ensure that each dose had been taken as planned through the MDI , and weighing the inhalers at each clinic visit to check compliance, which we duly did, only to be confounded some months later by a report from one of the trial nurses who had watched a trial participant standing outside the hospital dump-dosing the contents of his inhaler into the air before his scheduled clinic visit. Exciting – not only because of the satisfaction of making a genuine contribution to a research team on a project that genuinely made a difference to patients, but also because facing and overcoming personal fears and challenges can be an adrenalin-fuelled experience that builds character and self-belief
- So why do it? Well let’s consider the worst bits. Probably for me, it was speaking a my first international conference. It was hosted by the American Thoracic Society, at this venue in the image, which is larger than several football fields and attracted around 15,000 attendees. I used 35 mmm slides to give a verbal presentation to an audience of around a hundred. It only lasted about 15 minutes but I agonised over the content for weeks and was so nervous on the day of presentation that my hands were shaking. However, the feelings of relief and elation afterwards were priceless and I learned to deal with these situations more effectively as time went on. Incidentally, I’ve spoken to many senior and prominent clinical colleagues over the years, most of whom share some degree of anxiety about public speaking.
- So, on to the best bits of those early experiences. I acquired a whole host of new skills, such as statistical modelling, data management, and how to present research findings to peer audiences. I learned how research teams work and about the complexities of team dynamics, as well as how pharmaceutical companies work, including quite a bit of myth-busting around data-manipulation and the constraints imposed by medicines regulation. I met many colleagues as part of the research team and in networking opportunities at conferences and presentations. I developed confidence in my abilities and began to establish a research reputation in the field. I was a co-author on most of the publications arising from the trial and led several of the papers. Probably one of the most important gains was that I undertook and completed a PhD based on my work on the trial – that was mammoth challenge, but a story for another time. And some of the other best bits can be summarised as
- The adventure of it all!. The images are of the Bourbon Orleans Hotel in New Orleans where I stayed while attending one of the ATS conferences, and the paddle-boat steamer ‘Natchez’ that took me on a trip down the Mississippi after the conference was finished. The conference circuit has taken me to some amazing places – so it isn’t all nerve-jangling presentations!
- But a key question is whether the research made any difference in the long run? Did it have influence future research, did it change practice and did it change the lives of patients with COPD?
- The study was part of a development cycle that had its origins in asthma research. An evaluation of the evidence to support inhaled steroids as a therapy for asthmatics led to the design of a research study to evaluate their therapeutic value in COPD. The results of the ISOLDE trial were published in the American Journal of Respiratory and Critical Care Medicine in 2000, but one trial rarely provides compelling evidence for changes in practice. At around the same time similar studies were also completed in the US and Europe (though they didn’t include patient-reported outcome measures) and the results from all of these trials were combined in a Cochrane review published in 2002, that included over 16,000 patients from 55 studies, – showing that inhaled steroids reduced exacerbation frequency and improved quality of life in COPD patients. In the following year, the results of the trials and the review were included in international guidelines for COPD published by Global initiative for Obstructive Lung Disease – otherwise known as GOLD. In 2004 the results were also included in the first COPD guideline published by the national Institute for Health and Clinical Excellence, and in the combined COPD guidelines published by the European Respiratory Society and American Thoracic Society. Inhaled steroids are now frontline therapy for most COPD patients, but it was not the end of the story for research. The ISOLDE trial was followed by TRISTAN, a trial to investigate the impact of a combined bronchodilator and inhaled steroid on reducing exacerbation frequency, and after that, the global TORCH study, looking at survival rates in more than 4000 participants. And so the research process goes on.
- So, over the years, what have we learned about doing research projects in health?