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.

A more local approach

Opportunities for Participation, Involvement and Engagement

Why a more ‘local’ approach to research is beneficial to patients, carers and the public.

- a personal view from Derek C Stewart

There is always change in the NHS as it seeks to develop better treatments, care and services to improve patient experience. High quality systematically reviewed research plays a significant part in identifying and pursuing the questions that lead to such improvements.

As organisational changes take place across the NHS and the management of research develops, what might a more ‘local’ approach mean for study participation, active involvement and wider engagement?

Why does it matter?

I not defined by my illness even though it intrudes in many aspects of my life. I come before the label ‘cancer’. I am not keen to be kept in a ‘cancer box’ and only told about or involved about that type of research.

I live and access most of the services I use within 15 miles of where I and my friends and immediate family live.

I would like to know more about a much wider variety of research that I could easily access in my local clinic or hospital, e.g. I would be interested in research into psoriasis, osteoporosis, mental health, arthritis and old age.

I would willingly get actively involved with any researcher to prioritise areas for research identify the right questions, plan and design the study and all other parts of the process. Because of my work with the Clinical Research Network I am particularly interested in how get studies up and running in the NHS on time and meeting the targets that have been set.

However, most of the understanding, knowledge and the skills I have gained in trying to cope with my illnesses and conditions are shaped, for the most part, in the visits, consultations and interactions with those local services and support groups. The internet has become an increasingly important tool in gaining information and advice but I still like to meet people.

So, why am I so defined by my ‘cancer experience’? As one website has it: My name is not cancer! 

Of course, I want to see research on head and neck cancers and into the other two hundred plus cancers. I also want to see into other conditions that I, members of my family and friends have or might develop.  I want to see research that looks at the causes of illnesses, prevention, treatment, care and the services as well as living with and end of life care.

I want NHS researchers to work ‘for’ patients. I mean working towards better experiences for patients and users of services. I don’t mean that we employ the NHS researchers yet it is our money.

Evolution - The advent in England of Academic Health Science Networks (AHSN) & Centres (AHSC) alongside an evolving National Institute for Health Research - ClinicalResearch Network (NIHR-CRN) means there is a real sense of a more local focus in the planning, management and delivery of research.  

If you place this local focus together with the changes in the Research Excellence Framework for UK higher educational institutions then there are genuine and exciting opportunities to be gained for the public, patients and carers.

Academic Health Science Networks - The creation of Academic Health Science Networks [AHSN] is one element of an approach to transform health outcomes and the delivery of healthcare in England, bringing together the local National Health Service [NHS], Higher Education Institutions [HEI] and Industry to focus on improving the identification, adoption and spread of innovative health care across the network. The East Midlands AHSN has produced a MAP showing the 15 proposed AHSN areas.

NIHR CRN - The evolving NIHR CRN is now consolidating the links between the different topic and other networks by developing a more unified structure, building on the successes to date.

The revised and more integrated structure will be easier for researchers, the public and other stakeholders to understand and use. It will also help make national-scale improvements to our services. http://www.crncc.nihr.ac.uk/evolving_the_network/transition_programme_homepage

Research Excellence Framework (REF) – The REF provides accountability for public investment in research and requires researchers to produce evidence of the benefits of this investment.

This is referred to in the ‘IMPACT’ statement that has to demonstrate reach and significance. Researchers are asked to go ‘beyond the usual’ patient and public involvement, so new openings could be created for active involvement.

Collaboration – These developments are all reliant on strong collaborative and cooperative efforts by all concerned including members of the public asking about research opportunities in line with the NHS Consititution.

In many areas there are effective relationships between the different elements of the National Institute for Health Research and other stakeholders. The appointment of Simon Denegri as National Director for Participation & Engagement in Research at provides scope for further coordination. The focus on celebrating lots of different examples of good practice on International Clinical Trials Day being one example.

LOCAL ACCESS & OPPORTUNITY

Increased participation

A more locally responsible and managed collaboration between the NHS, AHSNs, HEIs and all parts of NIHR can result in increased participation in research. Local priorities can be identified. Studies can be run for more illnesses, conditions and diseases that meet the demographics and needs of people living and working in the area.

It becomes possible to have a joined up approach to informing the public and local media about research opportunities. Local media like local stories. The ‘ambassadors programme’ by NIHR CRN already provides support to people who are keen to speak with local media about the value of research in their lives.

A local ‘port of call’ can be created for people to inquire and gain information about signposting for research opportunities in line with the NHS Constitution. An advice line could additionally inform people about getting actively involved with research and encouraging better engagement.

Greater Involvement

A more local approach could mean that it is easier to identify the context and purpose of the involvement e.g. getting involved in design of research through the Research Design Service, CLAHRC and or NIHR Evaluation, Trials and Studies Coordinating Centre (NETTCC); involved in the delivery through the Clinical Research Network, etc. Of course there will be some crossover work but there is a better chance to meet, inform and partner with researchers in the local environment. A greater chance of building mutual relationships, trust and skills built between public and people who work in research in local institutions. Local is more likely to mean less travel to become and keep being involved.

Local communities, self-help and support groups have the opportunity to engage with individual topic research groups. Some areas have already brought these groups together. The North West People in Research Forum is a great example of collaborative thinking and pooling resources. The Primary Care in Manchester EngagementResource (PRIMER) provides another wonderful example.  


People in Research - West of England have also shown initiative in this area. Pen-CLAHRC are hosting a Conference in November 2013.

Leicestershire, Northamptonshire & Rutland - Research Engaging with Patients & PublicLNR- REPP and the development of a Nottingham, Derbyshire & Lincolnshire NDL REPP both illustrate how those working locally in research are coming together with the NHS. The North Trent Consumer Research Panel is a good example of a topic focused group.

Involvement encourages a more people-centred approach. The lay voice and representation (whether patient, carer or public) on Boards and committees can provide a powerful reminder of purpose and direction of travel.

Further cross-NIHR and other collaborative approaches could easily promote and offer places for more active involvement at the different stages of research leading to better recruitment.

There is greater scope at a local level for offering collaborative and coordinated workshops, events and meetings for people to learn and development knowledge and skills about involvement.

Wider Engagement

Local has the added value of engaging in the communities where people live and providing a mixture of information on both general and specific research for those communities. It is possible to set up calendars of regional events with newsletters along with other communications.

The benefit is that research increasingly becomes an important and valuable part of the patient pathway in all of our local NHS services. This could become a right of every citizen.

A citizen based approach means greater opportunities to learn from each other. There will still need to be topic focus but by working more closely together we can all be more informed about our own health and about how to improve research and services.

LOCALLY MANAGED

The phrase ‘locally managed’ should mean ownership and responsibility that builds on local knowledge of cultural and socio-economic population needs. The people who really understand those needs are those with experience of receiving services and those who might need them in the future.

Many of the existing organisations who are evolving into these new structures have a rich understanding of geography and the NHS. They already know where research is strong and the areas that need further development. The changes should provide space and flexibility in addressing those needs.

For patients and the public wanting to take part, get involved or just hear what is happening, a local framework will be helpful and clearer.  This should equally apply for researchers and managers with the formation of a coherent structure to engage and discuss. Research expertise and their knowledge of the research is in many respects based on clinical or service delivery.

FOR THE PUBLIC

Too often, the word ‘research’ comes after the diagnosis of an illness, condition or disease.

The reason these changes should take place is that…

·       More people knowing about research and taking part in studies

·       Research is a normal part of care pathway

·       Better evidenced based treatment, care and services

International Clinical Trials Day

International Clinical Trials day - 20th May

This is a great opportunity to get people talking about and involved in research. Start a conversation with people!

OK to ask campaign resources:

The OK to ask campaign materials are now available to order online from http://nihrcrn.org.uk/Index.php/ok-to-ask.html.

These include:

OK to ask campaign posters

OK to ask pull up banner

Additional OK to ask campaign leaflets*

Customisable OK to ask supporter poster**

*Please note: Organisations/Trusts are able to order a maximum of 100 leaflets each at no cost via email to crncc.comms@nihr.ac.uk. Additional leaflets can be purchased via the online system above

**Available from the online resource from Monday 6 May

We have also created an information card which will help medical professionals point patients in the right direction if they are asked about clinical research. These will be available to order from us for free from Monday 6 May, just send us an email with how many you need to crncc.comms@nihr.ac.uk.

If you have any questions about resources please contact crncc.comms@nihr.ac.uk.

OK to ask website:

The website is also now live at www.crncc.nihr.ac.uk/oktoask! Please point people towards this site wherever you can.

Thank you to all of you that have already shown your support for the campaign by sending us your pictures with the OK to ask campaign badge. You can see the pictures at www.crncc.nihr.ac.uk/oktoask/get_involved.

There’s still time to show your support by sending your photos to us via Instagram using the hashtag #NIHRoktoask, via our facebook page www.facebook.com/nihroktoask or by email to crncc.comms@nihr.ac.uk. You can download the badge here.

Learning and Developing - Blog 2

What do we mean by  'Learning'?

FROM SCHOOL TO...

For many of us, learning remains associated with our school days and the formal acquisition of facts that were subsequently measured in a variety of tests or examinations. The outcome being, for the most part, qualifications and future employment. This approach often assumes that we have little knowledge prior to the educational experience and that we will have gained information as a direct result of the process.

KNOWLEDGE & EXPERIENCE

Patients, carers and members of the public who become involved in research do not necessarily need knowledge in that formal sense. Learning for involvement in research is like walking across different stepping stones. It is rather like the old TV programme Blockbusters, where  a contestant seeks their way across a playing board, knowing some of the letters and guessing at others.

The questions that often need addressing for active involvement are far more basic: What am I doing here? What is expected of me? Why is this of value? What do we each get from the experience? Will it make a difference?

This puts a different emphasis on the idea of learning. These questions place the learner at the centre with their needs as the starting point. 

Members of the public, patients and/or carers do not need to know about all matters relating to research and science or all the issues about health and medicine in order to function effectively. In fact it would entirely negate and defeat the whole purpose of involvement if people needed to learn everything although there are examples of people becoming researchers.

It is their experience, either as a patient or carer. It is the experience gained in other walks of life that can be brought to the table by members of the public.

INSIGHT & PERSPECTIVE

The purpose of involving people is fundamentally to bring the insight of the person who has and may use a service, the carer’s viewpoint and/or an external perspective into any aspect of research from study development to trial management. It is the direct experience and/or different lens that is being offered from outside the normal research community to help add value and maybe bring fresh thinking. The concepts are of informing, forming and influencing research  for an  individual study or in national policy. The wisdom of experience.
A person asked to give their views about a research proposal or consulted about the questions to ask only needs to express their opinion. They may also want to get more involved.

People who get involved do not really need to know anything other than their own experiences and be clear about why they are involved and what is needed. The rest is an added bonus that is made more meaningful by meeting others involved on the same endeavour.

THE OVERRIDING GOAL

It can be of benefit to know that involving people is Government Policy, that it is a condition of NHS research funding and that it is supported by many, many people. It is helpful to know that there are still some people have still to be convinced of its value. It is therefore as much about changing culture and practice as it is about improving research. The overriding goal is about improving the value of people's lives and experiences of health and social care services.

People who become actively involved do need information to assist them in whatever endeavour they are involved. If it is about reviewing a trial protocol the need may be to understand what is being looked at and what is required. If it about membership of a committee, it might be helpful to understand the purpose of the group, how it functions and it's decision-making responsibilities as well as what is expected of the person. It is also important to know and record whether the involvement has made a difference as this will help us measure impact.

It is often the combination of the experiences together with the information that builds a base of understanding that can then be used elsewhere. It is an empirical approach - knowledge being developed and learned through experimentation, observation and reflection.

It can be desirable to understand some basics about research and some general information about health, medicine and science as that language permeates much of the discussion. Not knowing these should never exclude anyone from getting actively involved.

SUPPORT & ADVICE

People do, of course, need some support, advice and help. People need to know how to find the information and knowledge that can assist them understanding the why, what and how of being involved. There is a need for signposting, alongside translation and interpretation of culture and language.

Opportunities for learning help clarify the purpose of the involvement, the impact that is being sought and the expected outcomes. This clarity of purpose can help us all function more effectively.

LEARNING STYLES

We all learn in different ways. These are sometimes broadly divided into hearing, picturing and doing. We learn best through combinations of praise and challenge. We learn more when we have the chance to practice what we have learned. However central to all learning is building confidence, engendering self belief and helping people realise and develop their own potential.

The learner should, therefore, be able to choose from a variety of written information, workshops or self learning manuals. There should be choice about when and where the learner can access opportunities to learn and develop both in person and online.

Learning is about building new skills, experiences and knowledge that can help develop the effectiveness of involvement and the individual. In research, as in other parts of the NHS, is really about developing relationships, partnership working, seeking solutions together, managing each other's expectations and coping with conflicting opinions.

Richard P Feynman, offers a great opinion on learning:

"Study hard what interests you most in the most undisciplined, irreverent and  original manner possible."

LEARNING FOR ALL

This whole approach applies equally to researchers and managers who want to involve others in their work in either partnership or merely a consultative manner. They too need support, information and knowledge to help them understand why they want/need to involve patients, carers and the public in their work.


The next Blog will focus on the needs of researchers and managers about involving people.