The James Lind Alliance ….. the story so far. NICE Conference Tackling Health Priorities 7 th December 2006

Who am I? Sally Crowe, Chair of the James Lind Alliance Experience in Patient and Public Involvement (PPI) in health and social care research, and services development Interest in patient based evidence influencing/being part of the research agenda Personal experience……………..

Challenging questions Do uncertainties considered important by patients and clinicians influence the clinical research agenda? Can the NHS easily identify unanswered questions about the effects of treatments which patients and clinicians agree are important?

Addressing the challenges Creating an awareness of the issues Working Partnerships Populating the Database of Uncertainties about the Effects of Treatments (DUETs) Working on methods to move from DUETs to a set of agreed priorities in treatment research Being open and transparent about what we do, and how we do it

What has been achieved so far? Established a network of Affiliate organisations and individuals (130 plus) Developed a Database of Uncertainties about the Effects of Treatments (DUETs) Different Working Partnership models in asthma, and incontinence Bibliography (and systematic review?) of published work that addresses treatment uncertainties Described methods and processes for: priority setting in research; developing a patient/clinician friendly taxonomy; working in partnership

What of the Affiliates?  There are  The majority are statutory/professional organisations; charities and patient led groups are currently under represented  Their reasons for affiliation include philosophical issues, methods and networking  They have a lot to offer the JLA

What’s in store for 2007? Seminars: “Relationships between patient organisations/charities and industry” - AMRC and JLA “Applicability of the results of randomised trials” - Lancet and the JLA “Identifying your research priorities” – (aimed at patient groups and charities) – AMRC and JLA Research priorities – Asthma Case Study Evaluation – study of the work of the Incontinence Working Partnership

The James Lind Alliance: the wider context of Patient Involvement in Medical Research Dr Sophie Petit-Zeman Association of Medical Research Charities NICE Conference: 7 th December 2006

What’s all this about? What does “Patient Involvement in research” mean? Why does it interest me and medical research charities? How does the James Lind Alliance’s work fit with what others are doing? How might it all fit together in 5 years time?

What does “patient involvement in research” mean? Probably not this:

“Patient Involvement” should mean: Heeding Hilda Bastian: “Researchers cannot assume that their own values and priorities apply to others who do not share their world” Remembering that “Patient Involvement” means different things to different people…..from helping plan research to being in a trial Remembering that “Public Involvement” may mean much the same thing - ‘the public’ are likely to be patients too (…but this opens up a hornet’s nest…DIPEx ( can help….. Remembering that carers matter too – e.g. Alzheimer’s Society, Quality Research in Dementia

Why does it interest me and medical research charities? Medical research background that moved from basic to clinical Mental health – some hostility to “biomed”/big “user movement”/clear need to align priorities Charities need pragmatism: (1) to do their business well (2) to keep supporters happy Often have diverse “membership” and hence recognise complex range of drivers

How does the JLA’s work fit with what others are doing? (1) “Do uncertainties considered important by patients and clinicians influence the clinical research agenda?” Lots of others care about this question - & JLA works with them, e.g: - UKCRC/N - Charities/patient groups/AMRC - INVOLVE - NICE

How does JLA work fit with what others are doing? (2)  UKCRC PPI group – 4 strands:  “Dating agency”  Helping funders assess where PPI adds value  Enshrining PPI in NHS contracts  Assessing the evidence that PPI ‘works’  UKCRN working to ensure their avenues are right for what patients want  Charities are doing it…diversely…  AMRC trying to pull it all together

How might it all fit together in 5 years time? Clearer evidence for what Patient Involvement can (and cant’) do Helping people to do it Collaborating not competing Not regulating (probably?)

Identifying patients’ and clinicians’ questions about the effects of treatments Mark Fenton Database of Uncertainties about the Effects of Treatments (DUETs) and Secretariat, James Lind Initiative

What is DUETs Web based database of uncertainties submitted by patients, carers, clinicians and identified from BMJ Clinical Evidence, clinical practice guidelines, Cochrane reviews and protocols, NICE recommendations, and the NHS HTA Programme

DUETs’ working definition of uncertainty about the effects of treatments No up-to-date systematic reviews exist OR Up-to-date systematic reviews show that uncertainty exists

WHY have DUETs? ‘…to publish uncertainties that cannot currently be answered reliably by referring to an up-to-date systematic review of existing research evidence.’

What will it be used for? DUETs is being developed to help those prioritising research in the UK to take account of the information needs of patients, carers and clinicians, as promoted by the James Lind Alliance.

What is in DUETs? DUETs draws on three main sources to identify uncertainties about the effects of treatments : –patients', carers' and clinicians' questions about the effects of treatments –research recommendations in reports of systematic reviews and clinical guidelines –ongoing research, both systematic reviews in preparation and new 'primary' studies

Challenges Identifying outcomes that matter to patients Harvesting patients’ and clinicians’ unanswered questions about the effects of treatments

Identifying outcomes that matter to patients Everything works! If you use outcomes that a patient or clinician wouldn’t recognise What do you want treatments to do? what should researchers measure how should they decide on the question to answer?

Do automated/mechanical chest compression devices improve survival in adult out-of- hospital cardiac arrest? –Outcome – Mortality – No difference –Outcome – Survival – a non statistically significant increase of 40% in the "risk" of surviving Identifying outcomes that matter to patients

Alexander J, Tharyan P, Adams C, John T, Mol C, Philip J. British Journal of Psychiatry Jul;185:63-9 Rapid tranquillisation of violent or agitated patients in a psychiatric emergency setting. Pragmatic randomised trial of intramuscular lorazepam v. haloperidol plus promethazine.

‘.. carers said they wanted to see their relatives quiet and not causing a problem in minutes. They were for the use of injections, if needed ( people respect injections, sometimes inappropriately, in these parts). Most were not for the use of restraints, unless absolutely necessary. The patients themselves were grateful that they were given treatments that got them better but their opinions were more mixed than the carers.’ Identifying outcomes that matter to patients

Challenges & future developments Formalising a recognised structure for reporting uncertainties in systematic reviews and trial reports Going ‘industrial’ – Electronic submission from NICE research recommendations, HTA calls for research, National Primary Care Q&A Service, National Electronic Library for Health Specialist Libraries Starting an list to support interest from outside of the UK Guiding others with the experience of one!

To visit DUETs go to: