Challenging Expectations of Involvement in Research

Speaking today at Department of Health Sciences, University of York on the topic of challenging expectations of involvement in research. The following notes reflect the content of a number of my slides.


Involving the public in research can be challenging for the researcher, the public and the research itself. 

So, how do we ensure that involving the public is effective and has mutual value?  

The researcher may only want to tick the box, answer the PPI question or help get funding.

The public may want more research in one area, or get the latest information about upcoming studies, or just get better faster

Any meeting between the two may shift and alter the research but this should be to common goals...

• The best and most relevant question,
• Research that is patient centred throughout
• Reference to Incidence and need
• Clarity around the difference it is seeking to make
• Readable lay summaries
• Understandable information
• Appropriate and effective involvement
• A fully costed plan.
• and the answer to where the results will be reported

An agreement (less than half a page) should be sought between the researcher and the public which outlines the following...

Context - e.g. Type of research; part of research cycle; or research organisation

Purpose - e.g. To review a protocol; check the question; be on a study management group

Impact - e.g. To improve the language; to help with the inclusion/exclusion measures

Benefit - e.g. So what x 3 - to the Research; for the researcher; and for the lay person

I have now added some others

Expectations - e.g.Meeting expenses; support, learning and development

Review - e.g. To reflect and capture the impact/benefit

Publish - e.g To record any added value from involvement

The agreement should also state exactly what the research and public can expect from and of each other.

It is only by having such an agreement that we will meet our expectations of each other and make a difference.

There are, regrettably some myths of involving the public which need challenging.

PPI is NOT a distinct and separate activity, an additional burden. It is common sense, simple and should be the driver of the research

You do NOT need to have 2 people on a committee as there are many other effective ways of engaging and involving the public in research

A Reference Group is NOT essential as you could have a series of focus groups or adapt a local patient self-help group

Payment of honoraria is NOT mandatory. Many members of the public will willingly give up their time to help and support research especially at the early stages. IF however you are placing the person in a role on a committee, or as a research partner then payment should be considered.

You do NOT need to start afresh every time you do a new piece of research. You can call upon people who were involved before or just reference what they said

You do NOT need to use same people throughout. You can have a mixed economy of involvement: someone who advises, a focus group then reporting to a different patient community whilst maintaining some contact with then all through a newsletter update.

Involvement does NOT guarantee funding although if done well it might help

The Lancet and Department of Health jointly hosted a Symposium: The Lancet Series on Research: Increasing value, reducing waste

The Symposium was initiated by an article about the issues of increasing value and reducing waste in research by Iain Chalmers, Paul Glasziou et al., in 2009. The paper calculated waste as being as high, in some cases, as 85%.

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The series of papers presented at the Symposium further developed this theme and responded to the following specific areas…

·       Questions relevant to users of research

·       Appropriate research design, conduct and analysis

·       Efficient research regulation and delivery

·       Accessible full research reports

·       Unbiased and usable reports

These issues should equally be of importance to patients, research participants, their families and the public. Each area will help find answers in a speedier, more efficient, appropriate and honest manner. This should subsequently lead to better advice, care, diagnosis, treatment and services.

These are the real challenges we must address whilst also helping researchers develop better research.

The Value of Working Together

What is the VALUE of us working together to improve research for better treatment, care and services?

On Monday, 9th December, I helped facilitate an event in Manchester that set out to explore The Value of Working Together in Research. Hosted by North West People in Research Forum http://www.northwestpeopleinresearchforum.org the participants came from a broad spectrum of community voluntary groups, Local Healthwatch, NHS as well as the more usual patients/service users, carers and researchers. Twitter feed was #TVWT @nwpirf

The event was organised by Bela Starling, Irene McGill, Melanie Chapman and Joanne Simpson. 

I was struck by how different people had viewed the word VALUE. Bela and I wondered at one point whether VALUE was too vague yet we immediately agreed that it allowed for a much wider interpretation and exploration.

Dr Katherine Froggart, Senior Lecturer at the Faculty of Health at Lancaster University talked about relationships, the working with and using an action research approach to involvement, a community conversation and invited us to look to the future with research that looks at the whole person and their wider needs from their perspective.

Katherine stressed the importance of addressing practical worthwhile research, is done in a participatory way and that it is part of a continual responsive process.

Prof Ann Jacoby, Professor of Public Health and Policy, University of Liverpool talked about the PiiAF http://piiaf.org.uk  and having an ethical approach - the right to be involved (normative), the improvement for research (substantive) and the values around involvement (process).

Prof Carrol Gamble, Professor of Medical Statistics, University of Liverpool talked about how involvement is valued by Chief Investigators and Representatives of public and patients and that the incorporation of patients, carers and public should always be in research proposals.

Dr Philip Bell, lay representative, was interviewed by Bela Starling, spoke about his experiences of being on a variety of groups and committees and the importance of paying travel and other expenses as an absolute mimimum.

MY OWN THOUGHTS

As the day progressed and since I have begun to identify three broad strands that I heard about the term VALUE. The first was the was that of our 'morals' - our attitude to each other and the manner in which we work. The second centred around the 'benefit' - the impact and gain for each other. The third, I believe was about  'worth' - the value we place on recognising people's contribution. 

MORALS - i.e. the way we conduct ourselves when working together was raised by a number of speakers and in feedback. The importance of openness from both patients/public and from researchers. 

One of the main reasons for involvement is to let in fresh air and to have perspectives based on experiences and different knowledge. It is our morals that will help improve the culture and climate towards better person-centred research based on actual experience with the aim of better diagnosis, treatment and care. 

BENEFITS - i.e. the difference that has been made through involvement.  An increasing amount is written about the impact of involvement on the ideas, design and delivery of research yet less information is gathered on the positive difference to our lives. 

It is highly unlikely that I would have taken on any of the roles and positions I have held unless I had become involved in research as a patient. Similarly I have not been to see my doctor for over 8 years as I have more of a sense of my own health and well being.

This years NIHR Annual Report quotes Chris Peters, a trial participant, "Research and becoming actively in research, has changed the way I manage my condition and has led to me being more fit and healthy”. iewer.zmags.com/publication/26f799ac#/26f799ac/18 

There are therefore benefits for us as people in learning more about our illness and our general well being. Additionally we are gaining new information and developing different skills. 

Have researchers had similar experiences of benefitting personally from actively involving people?

WORTH - i.e. the recognition of people for their efforts. First and foremost a simple thanks, a card, a letter expressing gratitude. Payment of travel and any out of pocket expenses in cash is a strong favourite. A cup of tea and some biscuits can be helpful. Each is a simple acknowledgement of the contribution being offered. 

Better still is a regular update of progress outlining what happened as a result of being involved and how that made a difference to the research. 

The cost of involving people in any further activities can be worked out using the excellent Cost Calculator produced by the Mental Health Research Network and INVOLVE can be found at http://www.invo.org.uk/resource-centre/involvement-cost-calculator/

The general altruism of the public knows virtually no bounds as is evident in the 637,976 people who took part in NIHR approved studies last year. However people have a right to know what happened as a result of their participation in research. 

In the Final Report of the EFGCP Multi-Stakeholder Roundtable Meeting on “Sharing Clinical Trial Data in the Interest of Patients and Research”, participant Ingrid Klingmann said:

"We have to do more to get back to individual patients invoked in clinical trials, we owe that to patients for their willingness to contribute to the trial. At present the concept is not embedded in the proposal regulation - but as a fundamental right it should be."

MY TWEETS on the DAY

Here are the Tweets that I posted about VALUE and on reflection I now feel that I could have batched them more effectively into the headings I have since identified. This has been an interesting experiment of comparing the difference between my tweets during an event and the potentially more thoughtful reflection.

I was tweeting my views rather than necessarily reflecting the day.

My ten tweets, on the day, were WORKING TOGETHER in RESEARCH should aim to have these VALUES...

1. OPENNESS to different perspectives and alternate ways of working 

2. PRESENCE at meetings, events and conferences of the people for whom the research is intended

3. RESPECTING each other's views and opinions even when we disagree with each other 

4. LISTENING to each other's needs and working together to address them

5. LEARNING from each other's experience, knowledge and skills to develop better solutions

6. DIVERSITY to ensure that research meets the actual needs of those intended to benefit

7. EQUALITY to ensure that as many people as possible get the opportunity to take part in research studies

8. MUTUALITY as a set of common goals to improve research ideas, design, delivery, dissemination and application

9. CHOICE to take part in research studies and get actively involved 

10. IMPROVEMENT in treatments, care and services for people's health and wellbeing 

RUNNING & the ART of INVOLVEMENT in RESEARCH

Running and the art of active involvement in NHS research

SOME BASIC QUESTIONS 

How do you get involved in something you have never done before? Where do you start? What do you need? How do you get help? How do you keep going in the face of adversity? How will you know if any good has come of it?

Taking up Running

These questions were just some of the myriad thoughts that swirled in my head when I began to contemplate taking up running as a hobby. This article is my attempt to reflect on the many similarities and differences between running and the art of active involvement in NHS research. I specifically use the word 'art' for involvement as it too often seems to require specific experience, specialist skills and abilities. Whereas with my running, there is little artistry about it and no previous experience is necessary.

I began my thoughts about running by considering the personal barriers that might stop me.

Maybe I am too old? I have never run anywhere in my 60+ years. Was running something I really wanted to do? I have never been a sporty or active person. Perhaps I am too set in my ways? I garden and have put on my boots for occasional wanders in the countryside but these have been the sum total of my physical activity. 

Getting involved in Research?

I had the similar questioning thoughts when I first became actively involved in clinical research. I was never very good at science, I didn't know anything about research. What was it about? Would I be listened to? Would it make any difference? What might researchers think?

There is however a major difference between these two activities. If I put 'running' into a website I can get information, advice and support that is clear, understandable and accessible - even from the NHS. If I type 'research' I am overwhelmed with mainly academic references, a perplexing landscape and a lack of information, advice, support - even from the NHS. This is as equally confusing should I want to take part in a research study or become actively get involved with researchers.

Running offers me clear choices. Research still leaves me confused at times (Sadly, I DO know my way around the research world but when you try to help others you see too many of their eyes glaze over!)

Taking up the Challenge

I have come to realise that taking up new challenges is good for you and good for the activity with which you choose to get involved. Without people taking part in research studies there would be very little research. Without involving patients much of the research would miss the point of improving patient outcomes and getting more realistic end points. 

The challenge I am contemplating is to tun a series of 5k races in 2015 to mark the twentieth anniversary of the diagnosis of my cancer. I have become so much more healthy since I have taken up running especially as I broadening my understanding of diet, other training needs and better equipment.

Our health and well-being are generally enhanced by being actively involved. We learn, we meet others, we develop new competences whether it is in pursuit of physical activity or seeking to help NHS research. Some of these are transferable skills others are new and developing competences.

A QUICK HEALTH CHECK

I run, yet I wouldn't call myself a 'runner'. I am actively involved in research yet I would never call myself a 'researcher'. I have now run my first 5k and came in the very respectful last place and felt as if I had won a gold medal. I have been actively involved in research for over thirteen years and am pleased with the progress yet taking up running has made me think more about how we help others to be part of our community.

It is not necessarily about great discovery in science nor is it about achieving great times and breaking records. It is about incremental improvements. It is about making practical changes to research and in my health. It is about getting actively involved, being part of a community, gaining a broader understanding, recognising the benefits of participation.

INFORMATION & SUPPORT 

For both active involvement in research and active running it is about making sure people have the right support, in the right way and at the right time to enable and empower them to take part. 

If I type 'running' into a general search engine then I get to look at a variety of sites, clubs, clothes and shoes. I can choose which those that best suit my needs and what I want to do. There are Apps for my phone that put me in control and maintain my own personal records of progress.

Where are the Apps for Research? Why do I have to wait for months to take part in a course or an event to find out what it is all about?

There is an even a stronger correlation between running and the NHS. 

The running programme I choose is called From Couch to 5K http://www.nhs.uk/livewell/c25K/Pages/couch-to-5k.aspx  It is actually available on the NHS Choices website and offers 6 programmes to help you take up running. Furthermore I can watch videos to help with Flex and Strength and download further advice. 

I wish something similar would help me participate and get involved with research but if I type in 'research' in the Choices website it is not as simple. 

AWARENESS & ACCESS

But first and foremost you have to know that you can get involved. The NHS Choices website is a good front door but it was a colleague, Jamie Spencer, who pointed me to the NHS Couch to 5k programme and the other apps that allow me to keep track of my fitness schedule.

Word of mouth, someone pointing you in the right direction, is crucial.

It is not one or the other - it is both. Unfortunately getting involved in research almost entirely reliant on people telling you about it unless you have a particular disease / condition or know about some of the many acronym organisations in a local area - so try out AHSN or CLAHRC for a starter.

Running is universal. I am not divided up into a runner over the age of 60 or someone who has had cancer until I choose to record that information for a race. Running is running. Involvement is involvement.

LEARNING & DEVELOPING

The NHS choices website also has advice and information about running better. It recommends other Apps to help. I use Endomundo as it uses satellite tracking to record my runs, has a diary where I can note my progress.

I have now joined my local authority run gym where after a short introductory session I am free to choose which equipment I 

So, where are the Smart Apps that support my involvement? Where is the website that allows me to keep track of my active involvement in research?

SUMMARY

Running  clearly illustrates how people can be given information, helped to become active, supported in the way they run without having to join a group, a club or a committee. It is about using IT to support people and give them choices.

I am fitter and healthier although sometimes a little out of breath.

A MOVEMENT for CHANGE?

In preparation for a talk at the Sarcoma Patients EuroNet (SPAEN) Conference I began thinking about what we as patients are trying to achieve to improve patient outcomes through our involvement in research in England.

A Movement for Change?

Simon Denegri, NIHR Director for Participation and Engagement in Research,  often mentions that we are a 'movement' helping to improve research. I talk about many of the different impacts that we have made, as patients, and refer to the 'changing culture and climate' taking place in research. 

But, what do we mean by these terms and what are we all trying to achieve?

Separate Silos or a Collective Voice?

It seems to me that we became actively involved to improve research and to move to a more collaborative approach in which patients would be viewed as partners.  Yet, subsequently we formed our own groups and created our own silos without any real clear set of common overarching aims. 

We become too defined and fixed by our condition, an organisation or by geographical locality. We argue the differences rather than the overall purpose.

A Common Purpose

I have begun to set out below some headings in BOLD that I believe are areas of common purpose that we should all be seeking to achieve as patients, carers and the public. Each heading is followed by an explanation of why I think it is important. 

Do you these headings provide us with common aims? Are there others? 

BETTER RESEARCH - The drive for more relevant and appropriate research based on patient experience that has patient benefit as a key outcome measure. This means working patients, carers and the public working together with researchers and those in the health services. Organisations such as the Research Design Service (RDS), the Collaborations for Leadership in Applied Health Research and Care (CLAHRCs) and NIHR, Evaluation, Trials and Studies (NETS) are the natural places to inform and help shape research.

SIMPLER EFFECTIVE RESEARCH SYSTEMS - The push for less unnecessary bureaucracy and regulation that delays research. Regulation is clearly necessary but how can we make it better. The Health Research Authority (HRA) is keen to have your help and sets out their strategy here.

CLEARER ACCESS - The right to know about research studies that are relevant is outlined in the NHS Constitution. Mystery Shopper campaign, I4A and other patient surveys.

IMPROVED RECRUITMENT - Improved research delivery The NIHR Clinical Research Network is evolving to provide more local ownership to provide an even better infrastructure to allow research to happen in the NHS.

OPEN ACCESS - Too many patients say that they never hear what happened to the research. Interestingly Doctors are also concerned about not being able to read all the information discovered in research. Ben Goldacre’s article in the BMJ is worth reading.

SPEEDIER APPLICATION - There is little point in doing research that sits on a shelf somewhere. Research findings should be used to improve patient care. NHS England says that 'the NHS belongs to the people' so it will be interesting to see how they promote research.

BETTER PATIENT OUTCOMES - This is surely the main end point for all patients and carers. The main function of NHS Research has to focus on questions that improve treatments, services and care that makes a positive difference to people's lives. 

SATISFACTION - What do patients think about taking part in research. I asked this question in my last blog and you can read it here. 

WHAT'S IT LIKE TO TAKE PART IN RESEARCH?

I must declare that I work one day a week for the National Institute for Health Research – Clinical Research Network. This is, therefore, as much a memo to myself as it is a plea to others.

Is taking part in a research study a good experience?

Would you do it again? Would you recommend it to others? Did you know that you can help to inform and shape what research is about? Would you like to know what happens to the research that you helped as a participant? Would you be keen to know more?

It seems particularly odd that, despite all the excellent work to help make research studies and clinical trials a standard part of NHS services, treatment and care, we don't know the answers to these simple questions. The reason is that mainly we don’t ask.

More people than ever are given and opportunity to take part in research trials and other studies. Much work has taken place to involve the public to help focus on issues that are important to patients and their carers. This involvement has helped improve the questions being asked, the design and delivery of research studies. 

There have been significant improvements in the length of time it takes to get a research study up and running through the NIHR Clinical Research Network. This will lead to the findings being applied to improve people's experience of care.

Last year over 600,000 people took part in NIHR studies and yet we don't routinely ask them about the experience. There are some examples of questionnaires and surveys by individual facilities, Trusts or by particular researchers but we don't universally gather people’s opinion, their views or perspectives about research. 

Such basic questions. Such a simple thing to do. Such a basic courtesy to those who have given their time and effort involving additional consultations and procedures, additional visits to clinics.

The recent publication of the results of the Friends and Family test is a good example of the NHS seeking to ensure that the voices of patient, carers and family are listened to and used to effect improvements in services, treatment and care. 
http://www.england.nhs.uk/statistics/statistical-work-areas/friends-and-family-test/friends-and-family-test-data/

But...what about research?

Patients and their carers agree to take part in research for a number of reasons. We do so willingly with a general altruism and perhaps a modicum of hope. We accept that taking part often involves further tests and checks. Most of us do not seek reward. Acknowledgement, a thank you and an update of what happened to the study is always appreciated.

Gaining ‘customer’ feedback is increasingly part of our everyday lives from shopping on Amazon to travel and holidays. Tim Kelsey wrote recently on Why NHS England is launching 'TripAdvisor' for patients via @Telegraph http://fw.to/Ao6wNxK Why not a ResearchAdvisor?

Sadly, I still here the words 'research subjects' as if we are merely an extension of animal testing - fodder to be experimented upon rather than human beings. It remains ‘us’ and ‘them’.

If we are to genuinely make research part and parcel of the patient and service user pathway then we need to address this fundamental relationship. Seeking and analysing the opinions of clients will help create a step change in the way research is delivered. Anecdotally, I suspect that we will gain a huge amount of appreciative positive feedback but we will also hear where we can make improvements.

The best way to ensure that the feedback we receive is relevant and of value is to actively involve patients, service users, carers and the public in the thinking, planning, design and application.

The people who use our services will help us ask the right question in the right place and at the right time.

The Mystery Shopper campaign was a great start at understanding what people can find out about research in their local area. It also worked because it used local people to go in and ask the questions.

But most importantly it is changing the relationship. It is patients leading the way. Patients as Leaders in Research – so how can we help develop more people asking questions?

I have begun MY list of questions that I would like to see asked. What are yours?


1. Were you given any information about research studies and clinical trials at the hospital, clinic or practice relevant to your needs? (addressing ACCESS to Research)

2. Were you given information about having a say in research - getting actively involved to help inform, form and influence the research agenda? (addressing ACTIVE INVOLVEMENT with Research)

3. Were you given information about keeping in touch with the actual study or research in general? (addressing ENGAGEMENT for Research)


4. If you were given information or spoken to about research (addressing SATISFACTION about Research experience)....

Were you spoken to with respect and dignity?

Did you have enough information to make an informed choice?

Did it involve any additional appointments? We're these inconvenient?

Are there any comments you would like to add?

Would you be willing to take part in further studies?

Was it an experience you would do again?

Would you recommend taking part in research to others?

This should be finished with a thank you for taking part in research and for completing the survey.