The James Lind Alliance Involving patients and clinicians in setting research priorities Beccy Maeso and Caroline Whiting James Lind Alliance

JLA Priority Setting Partnerships Involving patients, carers and clinicians in setting priorities for research Agree by consensus a prioritised “top 10” list of uncertainties for research Publicise the methods and results of the PSP Draw the results to the attention of research funders independently of the JLA JLA is a non-profit making initiative that brings together patients, carers and clinicians in priority setting partnerships. These partnerships identify and prioritise uncertainties or “unanswered questions” about the effects of treatments that they agree are the most important. – focusing on specific conditions or healthcare settings Research on the effects of treatments is usually led by researchers or funders. This can mean that it can fail to address questions that matter to patients and to the clinicians to whom patients look for help. This is why the JLA process focuses on patients and clinicians.   The aim of this is to help ensure that those who fund health research are aware of what really matters to both patients and clinicians. What do we do? Priority Setting Partnerships Patients, carers and clinicians Focusing on single conditions or areas Identifying uncertainties about treatments (broadly defined) Prioritising the most important for research A top 10

Why involve patients and clinicians? Who normally decides what gets researched? Researchers Pharmaceutical industry The priorities of people with conditions and the people who treat and care for them can be very different from those of researchers. There is some evidence that there is a mismatch between what patients and health professionals want to see researched and the research that is actually done. The James Lind Alliance (JLA) research Priority Setting Partnerships (PSPs) were created to address this mismatch – to help make sure that the research that is done gives the answers that patients, families and health professionals really need in their everyday lives. Shaping the research agenda: Giving a bigger voice to patients, carers and clinicians Making research relevant

What is the JLA? Established in 2004 by Royal Society of Medicine – Dr John Scadding James Lind Library - Sir Iain Chalmers INVOLVE – Sir Nick Partridge JLA Advisers and JLA Guidebook Principles of transparency, inclusion/exclusion, equality of voice and evidence base The JLA was conceived in 2004 to provide a framework for identifying ‘treatment uncertainties’ from patients, carers and clinicians which could be checked against the evidence based and then prioritised. As the method has developed, the notion of treatment has evolved into a more general definition of ‘interventions’ – in other words, treatments, care and other interventions that are designed to make a difference to patients and which can be tested and evaluated by clinical research. Who was James Lind James Lind (1716-1794) A Royal Navy ship surgeon and pioneer of clinical trials Transparency of process Equality - balanced inclusion of patient, carer and clinician interests and perspectives Exclusions - of non-clinician researchers for voting purposes, but who may be involved in all other aspects of the process - of groups/organisations that have significant competing interests, for example pharmaceutical companies Audit trail of original submitted uncertainties, to final prioritised list recognition that making priority decisions does not create new knowledge, but reviews existing evidence of uncertainty. Priority setting can only occur if the identified treatment uncertainties have been checked to ensure that they have not been answered by an up-to-date systematic review.

Prioritise uncertainties Priority setting workshop Patients, carers and clinicians A day of democratic discussion and ranking Agree the top 10

Completed UK Partnerships Acne Lyme Disease Alcohol-related Liver Disease Mesothelioma Anaesthesia Mild to Moderate Hearing Loss Asthma Multiple Sclerosis Bipolar Neuro-oncology Cavernoma Palliative and end of life care Childhood Disability Parkinson’s Cleft Lip Patient Safety in Primary Care Contraception Pressure Ulcers Cystic Fibrosis Preterm Birth Dementia Prostate Cancer Diabetes (Type 1) Schizophrenia Ear, Nose and Throat Sight Loss and Vision Early Hip and Knee Osteoarthritis Spinal Cord Injury Eczema Stillbirth Emergency Medicine Surgery for Common Shoulder Problems Hair Loss Stroke in Scotland Hidradenitis Suppurativa Tinnitus Hip and Knee Replacement Urinary Incontinence Inflammatory Bowel Disease Vitiligo Intensive Care Womb Cancer Kidney Transplant Treatment uncertainty: Wide definition: For example the anaesthesia PSP had in its top ten: How can patient care around the time of emergency surgery be improved? And How can we improve communication between the teams looking after patients throughout their surgical journey?

Current UK Partnerships Ageing and multi-morbidity Non-alcohol related liver disease /gallbladder disorders Alcohol-related liver disease Blood transfusion and blood donation Patient safety in specialist care Bleeding disorders Pessary use for prolapse Cellulitis Psoriasis Rare anaemias Common conditions affecting the hand and wrist Musculoskeletal Rare Diseases in Adults Coeliac disease Scoliosis Cystic fibrosis Teenage and young adult cancer Digital technologies for mental health Tissue engineering Early osteoarthritis of the hip and knee Type 2 diabetes Endometriosis Learning difficulties in children and young people in Scotland Fragility Healthcare Associated Infections Adult Social Work Hyperhidrosis Multiple Conditions in Later Life Idiopathic Intracranial Hypertension Facial Reconstruction Oral and dental health Broken bones in older people Mental health in children and young people Living with and beyond cancer Physiotherapy Miscarriage Again there are examples of the breadth of the use of the term “treatment uncertainty”: Patient safety in primary care Reflection of the change in health and care – living better or well with conditions

JLA International Netherlands Canada Eating disorders Dementia Hepatic glycogen storage diseases Fibromyalgia Hypertension Kidney Cancer Neuro-developmental disorders Germany Pancreatic Cancer Frailty Metastatic Breast Cancer Post mastectomy breast reconstruction Head and neck cancer Seniors (Alberta) We also help and advise on PSPs which are based on the JLA method - Dialysis priority setting in Canada - Dystrophic Epidermolysis Bullosa in Spain

Next steps Promote priorities to researchers and all funders Dissemination of findings Publications Conferences

Outcomes Q7. What are the benefits of breathing exercises as a form of physical therapy for asthma?

Outcomes

A lasting legacy: The patient “I found that being involved has given me back an element of control over my illness.  This is so much more than I imagined I could ever have done when I first became ill.  The workshop left me feeling that we patients have an important contribution to make.”  Irenie Ekkeshis, Sight Loss and Vision PSP

A lasting legacy: The clinician “This has changed how I practice medicine. It has changed my understanding of what it means to listen to patients. It has changed the language I use when I speak with them. Most importantly it has changed my vision of how to deliver the care we give them. It has made it our vision.” Noémi Roy, Rare Inherited Anaemias PSP

For more information… www.jla.nihr.ac.uk @LindAlliance Some of the challenges of undertaking a PSP Engaging with patients Engaging with clinicians Unpredictability Difficult data Measuring impact Success factors: A committed Steering Group Administrative support Resources A well-defined scope A vision beyond the top 10 Resources: We have a costings template. Headings include: steering group costs (at least 4 face to face meetings during the lifetime of the PSP PSP management which includes the JLA adviser costs (usual about 10 days’ worth of work depending on the complexity of the PSP) Administration time and project management Information specialist – this is by far and away the highest cost but it is worth spending here as it makes the PSP that much more efficient and more likely to finish on time and in scope Communications and website (includes the survey mechanism) Final workshop and all that goes with organising a mid-size face to face meeting. This will include additional facilitation costs depending on the number of facilitators needed over and above the JLA adviser. Publication of outputs Better to err on the side of caution and over estimate costs – could be around the £15k mark. @LindAlliance