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.

Taken up Running

I have been strangely quiet over the past few weeks. I have simply been it of breath. 

I have been trying a different diet and thought that it might be good to get slightly fitter as well. I started running and it was agony to begin with but over the past seven weeks I have gradually improved. 

I have been using The Couch to 5K programme that can be found on the NHS Choices website. I can say that it really works: http://www.nhs.uk/livewell/c25k/Pages/couch-to-5k.aspx

Last night I entered a 5K race and completed it in under 40 minutes.

I helped to raise the profile of the Throat Cancer Foundation http://www.throatcancerfoundation.org

I didn't seek any sponsorship this time as I wanted to know that I could complete the programme but have agreed to send £50 to TCF.

The race was organised by http://www.nice-work.org.uk and the results will be on their website.

So, what has this to do with Making a Difference apart from being healthier, fitter and thinner?

Open Access

Extract from the MRC Policy Watch 29th July 2013

A memo has been leaked to The Guardian newspaper which reveals that two pharmaceutical trade bodies planned to secure the support of patient groups in an attempt to resist calls for greater transparency of clinical trial data (BMJ, 27 July). The memo came from the European Federation of Pharmaceutical Industries and Associations, and Pharmaceutical Research and Manufacturers of America.

An open letter to The Guardian, supported by more than 80 signatories, claims that large numbers of life scientists cherry-pick data, hide null results, fail to employ adequate statistical power and reinvent the aims of studies after they have been completed to make it look as though unexpected findings were predicted (THE, 25 July). The letter claims that pre-registration — journals accepting future papers based on the design of experiments rather than results — would reduce these malpractices because incentives to make papers more publishable would be substantially reduced.

Research for all

Is Research for everyone? Does everyone get the opportunity to take part?

The Stroke Clinical Research Network in conjunction with the Stroke Association have produced a fantastic booklet for people affected by aphasia.

You can read a great blog about this from the Association of Medical Research Charities - http://policyblog.amrc.org.uk/2013/07/15/talking-to-everyone-about-clinical-research/

Well done to everyone involved.

Update of Involvement in the NIHR Clinical Research Network

Last week we had a meeting in Leeds of patients, carers and service users  from across the National Institute for Health Research.

As part of the event I wrote the following letter of how in the past year we have already seen some significant developments in patient participation, involvement and engagement in research.  So this seemed a good opportunity for a quick update!

Back in January, the NIHR Clinical Research Network published the results of its “mystery shopper” initiative – where patient research activists revealed how well local hospitals were promoting clinical research opportunities.  The report on this initiative went all the way up to Ministerial level and many NHS Trusts are starting to do more to promote research as a direct result of the findings.  A real case of “patient power” driving changes.

On International Clinical Trials Day in May, the NIHR launched “It’s OK to Ask” – a campaign to encourage patients to ask their doctors and consultants about local clinical research opportunities, and help the clinical audience to answer these questions.  NHS Trusts across the country held events to promote clinical research and thousands of leaflets were distributed, helping to raise awareness of the important role research plays in improving treatments for patients, and the need to treat patients as partners in research.  The campaign got some great local media coverage, and was also a hit on social media, with around 500 tweets using the campaign hashtag.  One exciting feature of the campaign was the way that patients got directly involved as local ambassadors, press spokespeople and social media supporters.  Thank you to everyone who took part in this way – you really helped the campaign to make its mark.

Many of you will remember the work we did together on “The Way Forward” report back in 2010.  This set out an ambition for the NIHR Clinical Research Network to move towards a phase “where the involvement of patients, carers and the public becomes more focused on improving research and its delivery, and leads to impacts that relate directly to Network responsibilities for delivering research relevant to NHS patients…”

With that in mind, I am sure you will be very interested in the NIHR Clinical Research Network’s Transition Programme.  Through this Programme, the Network will be moving to a clearer structure with 15 Local Clinical Research Networks, each supporting clinical research delivery across all disease areas.  A new contract is being drafted, which will set out the responsibilities for these local Networks, and you will be pleased to know that patient and public involvement and engagement features more strongly in these responsibilities than it has before.  In fact, the Transition Programme offers great potential for patients, carers and service users to become even more engaged on activities relating to research delivery.

It is also heartening that PPIE has being “built in” to the Transition Programme at all levels.  I am part of the overall Transition Programme Board, and Karen Inns is leading a piece of work to shape PPIE in the new structure.  Each Network PPIE lead is linked into one of the various working groups for the Transition, so have a fantastic opportunity to make sure that the patient agenda is part of every decision, and that patient views shape these important changes.

This is only a short snapshot, but I am sure that when we meet at our event in June, we will hear of many more inspiring initiatives led by/involving our patient, carer and service-user community – and think up many new ways to continue to build our community and strengthen our voice.

I look forward to working with you again in June and for those using Twitter - #WITR

RESOURCES AND LINKS

If you’re interested in some of the things I mentioned in my letter, you may want to check out these web links, where you can find more information.

I have also added a few additional links in too that relate to the patient participation, involvement and engagement agenda more generally:

Mystery shopper

www.crncc.nihr.ac.uk/mysteryshopperreport

Based on the work of patient “mystery shoppers”, this report shows that NHS Trusts could do more to promote clinical research opportunities to patients.  It also contains some useful statistics about patient attitudes towards clinical research.

http://www.crncc.nihr.ac.uk/resources/Reference+documents+and+reports

Still related to the mystery shopper, this page links to the questionnaire that patients used, and to a useful leaflet called “We do clinical research” which lists the various patient-facing NIHR leaflets about clinical research.  It is aimed at Trusts and professionals who recruit patients into trials, but may also be of interest to anyone involved in the research agenda.

OK to Ask

www.crncc.nihr.ac.uk/oktoask

This is the homepage for the campaign website.

http://www.crncc.nihr.ac.uk/oktoask/get_involved.htm

A good fun page with pictures of patients, researchers, NHS professionals and many others who sent in a picture to show their support for giving patients a stronger voice through the OK to Ask campaign.

Transition Programme

www.crncc.nihr.ac.uk/transition

This is the page on the NIHR Clinical Research Network that provides basic information about the Transition Programme.

It also contains an email address that you can use if you have any specific questions about the Programme.

 

IMPROVING STUDY RECRUITMENT - Blog 2

This blog reflects the second workshop being held on this topic for the Joint Research Office a great partnership between UCL, University College London Hospitals NHS Foundation Trust, and Royal Free Hampstead NHS Trust. The course details can be found here and it is taking place as part of International Clinical Trials Day - ICTD.

This is additional module and my last for the Building Research Partnerships workshops supported by Macmillan Cancer Support.

The notes here are directed mainly at patients, carers and members of the public. The previous workshop and blog looked more at supporting researchers. Thanks to Ros Yu and Madeleine Stewart for all their help.

Involving the Public in Study Recruitment

As patients, carers and members of the public we are increasingly invited as contributors to the research process, actively involved in the design, delivery and dissemination.

This movement for change has helped with the push to get more people taking part as research participants. In cancer this has increased from around 1 in 25 people taking part in studies in 2001 to almost 1 in 4 more recently.

For those of us who become actively involved we would consistently state that the earlier we are included the likelihood of better research.

How might we best improve RECRUITMENT to research studies?

It is possible to identify three areas where wisdom can be brought to bear - that unique experience of being the patient, family, friends and colleagues OR the external perspective as a member of the public.

•       SENSE – whether what is proposed matches what’s being recruited – providing the reality check that asks if the Emperor has no clothes.

•       RELEVANCE – whether the study seems appropriate to patient experience and sensitive to their needs - considering the time, place and burden of taking part.

•       LANGUAGE – whether the way the study is promoted is understandable – looking at the  both the verbal explanation and the Patient Information Leaflet

Roles and responsibilities

First and foremost we must be clear about the context for involving people, why it is taking place and what is expected. The following questions are those we should be asking of each other...

Purpose

·       What am I doing here?

·       What is wanted/needed?

·       What is the task in terms of recruitment?

·       How long will it take?

Impact

·      Will anything happen as a result of our discussion?

·      Will any changes be applied to this study?

·      What learning will be applied to future studies?

·      How are the findings being fed back to the researcher and to NIHR?

Benefit

·       How and when will we all be informed of progress?

·       Is the evidence of involving people being recorded?

Some QUESTIONS to explore around Recruitment

What might we look for Sense, Relevance and Language in HINDSIGHT?

Questions that help us reflect and understand why people chose not to take part in the study

·       Do you clearly understand the study?

·       How relevant to patient need does it seem?

·       Was the language used in the patient information leaflet appropriate?

·       Were the targets unrealistic (ie the numbers expected and the time it took)?

·       Was it a study that required extra visits to a clinic (burden)?

·       Were people just not interested in the topic?

·       Were there other problems associated with this particular study?

What INSIGHTS were offered earlier for Sense, Relevance and Language

 Questions that explore the preparatory planning and design stages of the research

·       What does it say in the section on Patient & Public Involvement (PPI) in the application form?

·       Is there any evidence that the researcher has talked to patients with this condition? 

·       Have patients been actively involved in design and development of the study?

·       Is there a plan for actively involving people throughout the study?

·       If so, then why has it failed to recruit?

·       How ‘lay’ is the lay summary?

Thinking about the INSIGHTS we might apply in the Future

LEARNING from Experience

Sense, Relevance and Language in the future - FORESIGHT

Considerations for helping researchers at an earlier stage

To think 'Patient'

To find out about patient self-help and support groups - especially on social media

To know about charities and other national/international patient organisations

To understand the continuum of patient involvement from consultation to partnership

To develop and sustain a plan for effectively involving the public

Technology

As patients and/or carers, it is of value to think far beyond our own experience and imagine what the public - those patients of the future might want/need. It is worth thinking about how technology and access to smart phones and tablets have dramatically increased in recent years.

So, how are might we use technology for Study Recruitment...

·       Informing People about Research – The recent consultation on the UKCTG provided some useful information but we need to find other means of using U-Tube, Facebook, etc.

·       Using Technology for Recruitment – Expressions of interest, eligibility, registration and capturing data about numbers interested, numbers recruited. Patient information leaflets could be given as an App to address a paperless concept to research.

·       Maintaining the Delivery of Studies – Informing participants of appointments, compliance reminders, gathering patient experience, monitoring patient responses to trial treatments and safety reporting.