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The JLA process described at the Mesothelioma PSP launch in December 2013 - video transcript

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So I'm now going to talk to you about what the James Lind Alliance is and about the method that we've developed for involving patients, carers and clinicians in setting priorities for research. 

Just to give you a little bit of background on myself, I'm an independent consultant to the James Lind Alliance so I'm self-employed. I'm not employed by the Department of Health or the National Institute for Health Research and I've been involved with the James Lind Alliance since about 2008. My professional background is nothing to do with medicine or health research.  I'm very much a lay person in this.  My professional background is actually in social research and, to be completely transparent, I know very little about mesothelioma and so I come to this as a neutral facilitator of a process in which I hope that you will participate as people with the experience and the people with the expertise. 

So what I'm going to cover in my presentation will be an overview of what the JLA is, a little bit about what we do and why we do it, and then I'll talk through the practical process that we've developed, the how.  And then at the end I'll touch briefly on the difference that we hope that it makes. 

So the James Lind Alliance strapline is 'tackling treatment uncertainties together' and essentially that means that we're interested in finding out what research is important to patients or the users of services, to carers and relatives, and to clinicians or the healthcare professionals that treat them.

The JLA was established in 2004 so it's almost ten years old and the people that set it up were Dr John Scadding who's a retired neurologist who at the time was involved at the Royal Society of Medicine, Sir Iain Chalmers, founder of the Cochrane Collaboration and of the James Lind Library and Sir Nick Partridge who at the time was chair of Involve, the patient and public involvement organisation.  So right from the start, the notion of the clinician working with the patient to improve the evidence base to meet need was really at the heart of what the JLA was about.

When we set up, we were an NIHR or National Institute for Health Research, funded initiative. We had enough funding to test the process to see if it would work, to develop this methodology, but the long-term aim was never to remain as a standalone initiative.  We wanted to be mainstreamed. We wanted to become part of practice and since April this year we've been part of the NIHR Evaluation, Trials and Studies Coordinating Centre, known as NETSCC, so our administrative hub is now down in Southampton and the JLA process is one of the methods that NETSCC uses to identify potential research projects.

Now why should we involve consumers?  And I don't know if I'm preaching to the converted here so I'll assume that perhaps I'm not and I'll present what we see is the business case for involving the users of research, involving patients carers and clinicians, because it's still quite an unusual thing to do. 

On the whole the research agendas in this country and beyond tend to be determined by researchers who may or may not have daily interaction with patients, and also by the pharmaceutical industries who obviously will have their own particular agendas that they need to meet.  A piece of research was published in The Lancet about 13 years ago which I think still very relevant and it was a bit of a precursor to the idea of the JLA coming about. So this piece of research looked at research that had been done into osteoarthritis of the knee and it compared the trials that had been done, with the priorities or the wishes of people with osteoarthritis of the knee, their families, and the clinicians that treat them. So in this table you can see there's quite a stark difference.  The majority of trials that had been done at that time, just over 80%, were to do with drugs, but actually when patients and clinicians were asked what their priorities were, they weren't that interested in drugs. They were much more interested in things like knee replacement and education and advice, so we knew at that point that there was a mismatch and more recent research that's due to be published shortly suggests that maybe that mismatch is still out there - to an extent. 

And at the JLA we think that it's the right thing to do to ask patients and carers and clinicians what they think research should address. Firstly, look at how research tends to be funded, we're looking at taxpayers money or patients' and families' donations to research charities, so it just seems like the right thing to do to ask them what they want research to address.  Also if we don't talk to the people that have direct experience of a condition, we could potentially be missing out on some really important areas of research and really important questions that would make a lot of difference to people on the ground.  So that's why the JLA exists. 

I'll talk you through now what it is that we actually do.  We established Priority Setting Partnerships and these are essentially partnerships of patients, carers and clinicians. They tend to focus on single conditions or areas of health care and they identify uncertainties or unanswered questions about treatments and then they work together to prioritise the uncertainties that they think are most important for research to address. The end product of any Priority Setting Partnership, or PSP, is a top 10 list of questions that patients, carers and clinicians want the research community to address.

We've done quite a few partnerships now. We've completed almost 20 and we've got quite a lot on the go as well, including now mesothelioma, and you can see that they're quite diverse ranging from incontinence to tinnitus, schizophrenia, prostate cancer, I'm currently working with the spinal cord injury partnership, childhood neuro disability, so really wide range of different areas.  But I wonder if to some extent perhaps something that many of them have in common is that they tend to be areas where the patient community in particular hasn't had much of an opportunity to influence the debate, or where people might be less empowered or marginalised in some way.  There's information about all of these partnerships on our website and I'll give the address for that at the end.

So I'll talk you through the priority setting process.  There's five key points.  Setting up a steering group, inviting partners to participate, gathering uncertainties (unanswered questions), prioritising those uncertainties, and then promoting those priorities to researchers and funders so something comes out of it at the end. 

So I'll run through each of those steps in turn.  Setting up a steering group - so we've done this now for the mesothelioma partnership. Since August we've been talking to people within the communities and identifying people that are able to give the time to be part of the steering group.  Steering group members will bring resource, time, expertise.   They attend meetings regularly, a lot of them over the phone, and they're involved in publicising the project, overseeing the process, and they're responsible for disseminating the results.  They don't have additional influence on the outcomes, that's why I'm there. The JLA's role is really to ensure that things are run transparently, fairly, that we address any undue bias and we ensure that all parties are able to participate equally.  And the partnership signs up to a protocol and we've published that on the project website and again I'll give you the address of that at the end.  It sets out who's involved what we're going to be doing so that you know exactly what we've got planned.

The next stage is to invite partners to get involved and that's really what we've started to do today with this launch. We're reaching out to patients, carers, clinicians and their representatives, their advocates in the organisations that work on their behalf.  And partners get involved as a consultative body, but also as organisations, with networks or individuals with networks, who can promote the process as well as participate in it. When it comes to the priority setting stages we ask everyone that gets involved to declare their interests so that everyone knows what each other's biases are and everyone will have them and that's fine.  We exclude from the priority setting process just two types of potential participant. We exclude pure researchers who don't have any clinical practice at all and we exclude representatives of the pharmaceutical industries and that's simply because, as we know, they have many other opportunities to influence the research agenda and that's just not what the James Lind Alliance is about.

The next stage of the process is to gather treatment uncertainties and our definition of an uncertainty, or an unanswered question, is essentially that the question hasn't been answered by an up-to-date to systematic review.  And a systematic review is a comprehensive review of all of the evidence out there addressing a particular question.  It weighs up the quality of that evidence and it brings the evidence together to look at whether or not that that question has been comprehensively answered.  If it hasn't then we would define that as an uncertainty.  So the main way that we will gather uncertainties is through a survey and that'll be online but also available in paper format and with an option of doing it over the phone for people that need to.  And that's primarily aimed at patients, carers and clinicians. We will also look at the literature that's out there to see what uncertainties have been identified through existing research, and we work closely with a resource called the UK database of uncertainties about the effects of treatment for this part of the project, UK DUETs, which is part of NHS Evidence and it's run by NICE, so it means that most of the uncertainties that we gather will be published on UK DUETs. Even if they're not prioritised they're still out there available in the public domain for researchers to go and have a look at.

So here's an example from a previous partnership, the type 1 diabetes partnership, and you can see that we asked a pretty simple, quite broad, question. We asked what questions about the treatments for type 1 diabetes would you like to see answered by research?  We kept it as simple as that. We asked a few demographics so we were able to understand as we went along which groups were and weren't responding but we keep it simple because we want people to participate, whether they feel they know about research or not. They may know about research, they may know what unanswered questions are out there, but they might not, and for us the material that we want to gather is what people have noticed in their clinics, what people are experiencing on a day to day basis, to inform our process.

The next stage is then to check those uncertainties and we are going to be working with someone called Richard Stephens. So I know that some of you already know he's been involved in a recent review of mesothelioma research. Unfortunately, he wasn't able to be here today but he will have the job of working through that data, removing any submissions that we get that are out of the scope of the project.  He'll categorise those submissions and then we'll format them into researchable questions. The next job is then for Richard to check those unanswered questions because it may be that there is a systematic review out there that answers them.  And what we will then end up with is a verified long list of unanswered questions to do with mesothelioma treatment. And I should say when I'm talking about treatments, I'm talking about interventional research, so it could be treatment but it could be something to do with care or diagnosis.  It's anything that you do to a patient that will or should make a difference.

So back to the type 1 diabetes partnership as an example.  They had almost 600 respondents who between them came up with just over a thousand uncertainties.  When those were checked, just under 900 were true uncertainties, and they identified another 118 from the research.  A lot of those were duplicates or were very similar, and similar enough to be bunched together. And they ended up with 350 verified uncertainties. They then did another shortlisting exercise to bring that number down a little bit further. So now we've got a long list. 

It will have been a long hot summer for Richard Stephens, stuck in a room working through all that data.  We're now at the stage where we want to prioritise this data. We're working towards our top 10.  Because of the volume of data that we hope to get back we need to do an initial shortlisting exercise so we'll move from that long list to a shortlist. 

What we'll be doing at that stage is sending out to you, if you have expressed an interest in being involved, and to other parties, that long list and a pro-forma asking you to choose and rank ten of those questions.  You might want to do that as individuals or you might do it on behalf of members or colleagues if you're representing an organisation.  We recognise that different groups and different people have different capacities to do this exercise. It's really up to you to decide how you do it, as long as you're transparent with us about your methods.

So this is an example from the tinnitus partnership and the long list is on the left.  They had 170 questions in their long list which is quite a lot.  I'd like to say now, and I'm on record obviously, that we will not send you 170 uncertainties.  I hope it will be much more manageable number than that.  But actually we had a very good response to this and I think it was because the data was very well organised so people weren't overwhelmed by it. They were able to work through the categories quite easily.  And on the right hand side is the form that they used to rank their interim top 10.  So from that we will score the uncertainties.  We'll keep separate lists for patients, for carers, and clinicians so we're weighting the data.  No one’s going to be dominating that overall process.

We'll bring the results together and we'll have a final shortlist of about probably up to 30 questions, certainly no more than that, and those questions will go to a final priority setting workshop in which patients, carers and clinicians will get together for a day. We use something called nominal group technique, so it's a combination of discussion and ranking.  It's a very democratic exercise and it's facilitated by the James Lind Alliance so we ensure that people are able to participate productively in that exercise and together those groups will prioritise and agree the remaining uncertainties, they'll agree the final top 10. 

So these are pictures from previous partnerships.  You see here we're working in small groups.  Nominal group technique involves small group discussions, ranking, then bringing all the rankings together in a large group and debating them a bit more. There's lots of iterations of prioritisation, so everybody gets an opportunity to put their case for why they think something should be higher or lower down the list.  But ultimately there's a lot of compromise involved and a lot of pragmatism involved.

So this is from the type 1 diabetes workshop and it's a really exciting meeting and I hope that many of you will have the opportunity to attend.  I've always been so impressed by the amount of energy that people bring to that meeting and whilst many people will have very strong personal or professional interests in the topic, they also recognise the wider communities that have been consulted in this exercise and we hope that what we end up with is a is a top ten list that the whole community can feel a sense of ownership of.

So final steps. We've got our top ten.  We then want to do something with them, and obviously this partnership is slightly different to our other partnerships in that we've been fully funded by the National Institute for Health Research, so our one of our first ports of call will be the NIHR and the Evaluation, Trials and Studies Coordinating Centre to look through that top 10 list and to work with our steering group to turn those topics into robust, researchable questions.  There will be other ways to disseminate the findings. There may well be, I'm sure there'll be, other funders that are interested in the list.  We will want to disseminate the outputs to our patient audiences, to clinical and academic audiences as well, and I hope that you will help us and be involved in getting the word out there about the top ten.

I'll give you some examples of things that have happened from other partnerships just very briefly.  So our asthma partnership, which is one of the first ones that we did, one of the top ten questions that they identified was about the effectiveness of breathing exercises for asthma. So breathing exercises are commonly given to people with asthma but the evidence base for whether that's a good thing or a harmful thing is actually quite limited, and patients particularly were keen to know whether or not it was worth their while doing the exercises. Now it's generally been agreed that if that question hadn't been raised by a patient it probably wouldn't have come to light at all.  No one’s going to make any money from research into breathing exercises.  But it went through the JLA process and it's now been awarded funding by the NIHR's Health Technology Assessment Programme and there's a multicentre trial underway, I think it's based primarily in Southampton. 

And vitiligo was another partnership. There are a number of outputs from that and again you can get all the details on our website, but a pharmaceutical company is going to be running a pilot multicentre trial on number six of their ten questions.  So they weren't involved in the process, had no influence on it, but more than happy for them to pay for research to address any number of those uncertainties.

Our prostate cancer partnership - the steering group involved two of the major prostate cancer research charities, so for them the top ten went straight to influencing and informing their research strategies.  That's for Prostate Action and The Prostate Cancer Charity. And since their final workshop in October 2010 over 15 projects have been funded that addressed the priorities that were identified at that workshop.  And then more recently was the Sight Loss and Vision priority setting partnership.  They ran one data collection exercise, one survey, but from that they identified and ran 12 different priority setting exercises, that between them addressed over 100 eye conditions. They launched their findings at a parliamentary reception in October this year at the House of Lords and in November, Fight for Sight which is an eye research charity that funded this project, they awarded 24 small grants which address a number of the top tens across the different categories. 

And then finally, we've had an ongoing relationship with the NIHR's Health Technology Assessment Programme and a number of their calls for proposals for research have included priorities that have been identified by JLA priority setting partnerships, including for vitiligo, schizophrenia, and stroke.

So lots more information online. We've got the JLA website JLA.nihr.ac.uk.  We've also got an online guidebook which explains the process as I've explained it, but in a lot more detail, with lots more examples of previous partnerships, templates to download, lots of stuff on there so do go on and have a look.  And like I said, we're also on Twitter @LindAlliance and I tweet in my capacity as JLA Adviser and we'll be tweeting about this partnership @Katherine underscore JLA