FIGURING IT OUT

Reflections on Patient/Public Involvement with Numbers, Statistics and Data

Derek C StewartLynn LaidlawIrene Soulsby and Beatriz Goulão

The following notes were initially written in preparation for a meeting about Patient, Public Involvement with Numbers, Statistics and Data run by Beatriz Goulão in December 2020. Since then, it has developed into this article with contributions from the public partner participants and Bea.

It seems to us that that the active involvement of patients and the public with data, statistics and numbers is more than just possible – it adds up! The features and benefits we have categorised were identified from the various tasks we were being invited to consider. It was then possible to comment on how this might have value.

It actually appears more about what we, as patients/public, know already rather than needing to understand and immerse ourselves in numbers and/or statistics! 

It is an opportunity to learn about how statistics play such an important and increasing part in health research.

Our presence, voices and contributions seem to be focussed on assurances, reality checking and practical advice. It is a chance for mutual learning. It is less about our patient experience though that remains a valuable driver that keeps us going. 

In Lynn’s words our involvement asks the most fundamental question – “It may be measurable but is it meaningful?”.

SOME OF THE KEY FEATURES & BENEFITS

1. Involvement of Patients & Public can provide assurance to Statistical Research and to Statistics in Health Research by helping…

  • Integrity – to demonstrate openness, transparency and accountability
  • Value – the knowledge and understanding that is derived from experience, voice, insight
  • Quality – the improvements made from practical suggestions, alterations and advice *

These are as such the big-ticket issues about the moral compass of research, the democratising and the governance as well as helping improve its quality yet they signal important aspects of trust and probity. 

Ultimately, with publicly funded health research is what is being measured meaningful for patients or is it just about measuring what is measurable.

2. In real life terms Patients & Public with Statistical Research helps to

  • Ground research in reality: about relevance, the possible and what is practical
  • Make sense of numbers: Thinking about understanding of language, images, descriptions and communications especially with the interpretation
  • Motivate the work: Acceptability and assurance to give confidence or offer caution

A number of researchers have commented on how they find this reality checking a means of staying in touch with the direct or consequential purposes of their work. They are assured and reassured by the involvement. It helps confirm the value of the work or invites further thinking. This can also be reassuring to the public to know that the patient voice has been instrumental in developing the research.

3. The Involvement can provide practical advice and contribute to… 

  • Attitude and viewpoints of patients/public: thoughts, concerns, opinion and perspectives
  • Advice and comment on actual numbers: advice, insight, reach
  • Communication and dissemination on statistics language, graphs and pictograms

As patients we are often bringing that experience to bear directly on the intervention (the medicines, surgery, treatments, the radiotherapy, etc) yet here it shifts to providing a more general perspective that helps with meaning and understanding. 

WHAT COUNTS FOR PATIENTS & THE PUBLIC?

For those of us who are Patients/Public Partners and get involved with Statistical Research, we may consider gaining

  • Greater awareness about statistics and the trial methods that are used
  • Increased knowledge and understanding of statistics and health research
  • Improved critical skills to read, analyse and interpret data to challenge media reporting and fake news 
  • Strengthened ability to make more precise observations and ask improved questions when contributing to research
  • Better understanding of the role patients/public can play in this type of research
  • Bear witness to the efforts and ethical considerations that are taken

WHAT DOES THIS ADD UP TO FOR RESEARCHERS?

For those of us who are statisticians and are considering involving Patients and Public Partners in our research and our analysis, we may consider gaining

  • New perspectives to improve data collection, analysis and interpretation and ensure research results are relevant and meaningful: patients and the public will bring their own lived experience to important data related questions such as the best way to collect data, what to take into account when analysing it and how to interpret it in a real-life context. Numbers are meaningless without a context. Patients and the public are key in embedding numbers with meaning.
  • Better communication skills: researchers will have to develop efficient and clear ways to communicate about data, statistics and statistical methodology. This is will help develop their communication skills 
  • Greater empathy: for researchers that are rarely in contact with research participants or patients; talking to them about their research and statistical methods is an opportunity to better understand, first-hand, the impact data and statistics can have in improving people’s lives
  • Understanding of our processes and assumptions: having to present and explain our assumptions leads to better self-understanding of our own processes and biases which improve transparency, credibility and ultimately better research. 

A FINAL TALLY

It may be worth noting that a deep knowledge of numbers and statistics is not an essential requirement to get involved – that is the role of the statisticians!  A basic understanding of calculations, charts and data and an interest in how to capture and report the most appropriate information can be helpful. You might end up learning about data analysis, trends, forecasts and much more but only if you want.

We can bring, think and apply our knowledge from budgeting, reading graphs and charts in the media. It is a great opportunity to meet loads of people who are keen to involve the public in this type of work as they want to make a difference.

Research will ultimately gain from patient and public involvement in statistics: numbers underpin quantitative research; there needs to be clear and open discussions about numbers to avoid power imbalances and ensure all stakeholders feel equally heard during the research process. This will lead to research that is more democratic and relevant to patients and the public.

We, as patients want to know if research doesn’t meet its primary, statistical endpoint is it the intervention, the research methodology and/or medication etc that was ineffective or the way we chose to measure it? 

* Integrity, Value and Quality taken from Alice Biggane’s research https://researchinvolvement.biomedcentral.com/track/pdf/10.1186/s40900-019-0170-2.pdf

You can read Lynn’s recent blog post for HDR UK here –

If you are interest in learning more, the following sources might be helpful

Use My Data is a movement of patients, carers and relatives promoting the benefits of sharing data.  

HDR UK Voices – a network of Patient & Public Involvement with Health Data Research UK

Podcasts about numbers and risk with the statistician, author and broadcaster

FIGURING IT OUT

Reflections on Patient/Public Involvement with Numbers, Statistics and Data

Derek C StewartLynn LaidlawIrene Soulsby and Beatriz Goulão

The following notes were initially written in preparation for a meeting about Patient, Public Involvement with Numbers, Statistics and Data run by Beatriz Goulão in December 2020. Since then, it has developed into this article with contributions from the public partner participants and Bea.

It seems to us that that the active involvement of patients and the public with data, statistics and numbers is more than just possible – it adds up! The features and benefits we have categorised were identified from the various tasks we were being invited to consider. It was then possible to comment on how this might have value.

It actually appears more about what we, as patients/public, know already rather than needing to understand and immerse ourselves in numbers and/or statistics! 

It is an opportunity to learn about how statistics play such an important and increasing part in health research.

Our presence, voices and contributions seem to be focussed on assurances, reality checking and practical advice. It is a chance for mutual learning. It is less about our patient experience though that remains a valuable driver that keeps us going. 

In Lynn’s words our involvement asks the most fundamental question – “It may be measurable but is it meaningful?”.

SOME OF THE KEY FEATURES & BENEFITS

1. Involvement of Patients & Public can provide assurance to Statistical Research and to Statistics in Health Research by helping…

  • Integrity – to demonstrate openness, transparency and accountability
  • Value – the knowledge and understanding that is derived from experience, voice, insight
  • Quality – the improvements made from practical suggestions, alterations and advice *

These are as such the big-ticket issues about the moral compass of research, the democratising and the governance as well as helping improve its quality yet they signal important aspects of trust and probity. 

Ultimately, with publicly funded health research is what is being measured meaningful for patients or is it just about measuring what is measurable.

2. In real life terms Patients & Public with Statistical Research helps to

  • Ground research in reality: about relevance, the possible and what is practical
  • Make sense of numbers: Thinking about understanding of language, images, descriptions and communications especially with the interpretation
  • Motivate the work: Acceptability and assurance to give confidence or offer caution

A number of researchers have commented on how they find this reality checking a means of staying in touch with the direct or consequential purposes of their work. They are assured and reassured by the involvement. It helps confirm the value of the work or invites further thinking. This can also be reassuring to the public to know that the patient voice has been instrumental in developing the research.

3. The Involvement can provide practical advice and contribute to… 

  • Attitude and viewpoints of patients/public: thoughts, concerns, opinion and perspectives
  • Advice and comment on actual numbers: advice, insight, reach
  • Communication and dissemination on statistics language, graphs and pictograms

As patients we are often bringing that experience to bear directly on the intervention (the medicines, surgery, treatments, the radiotherapy, etc) yet here it shifts to providing a more general perspective that helps with meaning and understanding. 

WHAT COUNTS FOR PATIENTS & THE PUBLIC?

For those of us who are Patients/Public Partners and get involved with Statistical Research, we may consider gaining

  • Greater awareness about statistics and the trial methods that are used
  • Increased knowledge and understanding of statistics and health research
  • Improved critical skills to read, analyse and interpret data to challenge media reporting and fake news 
  • Strengthened ability to make more precise observations and ask improved questions when contributing to research
  • Better understanding of the role patients/public can play in this type of research
  • Bear witness to the efforts and ethical considerations that are taken

WHAT DOES THIS ADD UP TO FOR RESEARCHERS?

For those of us who are statisticians and are considering involving Patients and Public Partners in our research and our analysis, we may consider gaining

  • New perspectives to improve data collection, analysis and interpretation and ensure research results are relevant and meaningful: patients and the public will bring their own lived experience to important data related questions such as the best way to collect data, what to take into account when analysing it and how to interpret it in a real-life context. Numbers are meaningless without a context. Patients and the public are key in embedding numbers with meaning.
  • Better communication skills: researchers will have to develop efficient and clear ways to communicate about data, statistics and statistical methodology. This is will help develop their communication skills 
  • Greater empathy: for researchers that are rarely in contact with research participants or patients; talking to them about their research and statistical methods is an opportunity to better understand, first-hand, the impact data and statistics can have in improving people’s lives
  • Understanding of our processes and assumptions: having to present and explain our assumptions leads to better self-understanding of our own processes and biases which improve transparency, credibility and ultimately better research. 

A FINAL TALLY

It may be worth noting that a deep knowledge of numbers and statistics is not an essential requirement to get involved – that is the role of the statisticians!  A basic understanding of calculations, charts and data and an interest in how to capture and report the most appropriate information can be helpful. You might end up learning about data analysis, trends, forecasts and much more but only if you want.

We can bring, think and apply our knowledge from budgeting, reading graphs and charts in the media. It is a great opportunity to meet loads of people who are keen to involve the public in this type of work as they want to make a difference.

Research will ultimately gain from patient and public involvement in statistics: numbers underpin quantitative research; there needs to be clear and open discussions about numbers to avoid power imbalances and ensure all stakeholders feel equally heard during the research process. This will lead to research that is more democratic and relevant to patients and the public.

We, as patients want to know if research doesn’t meet its primary, statistical endpoint is it the intervention, the research methodology and/or medication etc that was ineffective or the way we chose to measure it? 

* Integrity, Value and Quality taken from Alice Biggane’s research https://researchinvolvement.biomedcentral.com/track/pdf/10.1186/s40900-019-0170-2.pdf

If you are interest in learning more, the following sources might be helpful

Use My Data is a movement of patients, carers and relatives promoting the benefits of sharing data.  

HDR UK Voices – a network of Patient & Public Involvement with Health Data Research UK

Podcasts about numbers and risk with the statistician, author and broadcaster

Changing Culture

A talk about patient involvement in research for Impact Frameworks and Cultural Change Conference from Derek C Stewart, a patient advocate in the UK and Hon Professor with NUI Galway, Ireland.

I want to reflect on the Cultural Changes that have taken place and what might happen next. The role of patient has changed from being wheeled out on a stage to be the exhibit to becoming more of a partner, colleague, critical friend. 

The curtains of clinical research may have been thrown open offering light and learning but is it time for open the doors and go for a walk together.

Research in healthcare, over the past thirty years have seen a shift from the patient being seen merely as the research subject – someone to be revealed on a stage behind a curtain to a select audience, looked at, probed, questioned.  We have become more of a partner, a colleague and essential part of improving the quality of research. The curtain, doors and windows in health research have been opened to allow light and learning. 

The greater involvement of Patients and Public has brought fresh insights, new thinking and transparency. Patient, Public Involvement (PPI) developed from mental health service users, the HIV and AIDS communities, disability movements, cancer patients and many more. Each in their own way addressing social change, altering the dynamics of power, shifting democratic processes and challenging the status quo yet we spend too much of our time looking at an individual research protocol and participant leaflets.

Involving patients and the public is increasingly becoming a cornerstone of effective public policy, particularly in health and clinical research but has the culture changed?. 

The Research Excellence Framework (the REF) and the focus on IMPACT – of reach and significance – have all helped in that journey.

I would argue that these have improved the quality of research – more relevant questions, more appropriate outcomes addressing qualitative experiences not just quantifiable, better and understandable participant information leaflets, better reporting of the evidence. More people are certainly taking part. There is greater interest in research becoming a standard part of the patient pathway.

Computers and smartphones have helped moved these changes at super speed and we need to think about how to make that step change in practice and culture that keeps up with digital technologies, artificial intelligence whilst essentially building and maintaining public trust.

As patient advocates, we spent years, learning about research, science, medicines and treatments as well as exploring different forms of Involvement in order to help.  We assimilated – In many ways we became more like researchers. We made changes to individual research projects, to some researchers and have in many respects gradually shifted the culture. Some researchers get it, they understand that involvement improved the standard and quality of research yet there is a long way to go. If a key member of the research team leaves the involvement can disappear in days.

The challenge is to make research more mainstream – Covid-19 has helped. R numbers, phase 1 to 3 trials, vaccine reliability, efficacy, have become the language for news bulletins.

The Zoe Covid-19 Study https://covid.joinzoe.com has online consent, gathering data, informing the participants, scientists, policy makers, politicians. Sending reminders, adapting the study to meet changes and ask other questions. Dissemination has moved from a conference presentation with a select few into the public domain and the realm of public communication. Webinars are open.

But when I read research proposals – I still see phrase such as ‘I will disseminate the findings at a Conference of my peers‘ let alone inform the participants of the results which is becoming mandatory in the UK through the Health Research Authority Transparency Agenda

In the UK we have focused on Involvement – the theory, practices and the processes. Too often this has been more than the purpose to improve health treatments and care.

In Ireland the focus is on improving health. Where research is a means of improving people’s health, it has become a joint endeavour, a common interest. iHealthFacts sets out to invite questions from the public about their health conditions. This helps researchers understand the questions people have and seeks to help them find answers.

Local people are empowered to help which in turn enriches their communities – through the Community Scholars Programme

Young people are enthused and encouraged to ask their own questions and become researchers running a study with the STARTinitiative. 

Researchers have been helped think about how they engage with the media though mentorships organised by Evidence Synthesis Ireland with Muiris Houston of Irish Times 

There are examples in the UK encouraging research to think differently. Genes and Health East London have 47000 people with a South Asian background signed to a genetics study. Manchester Biomedical Research Centre invites the public to be vocal about research. 

These examples illustrate that there are not hard to reach groups – more about hard to move researchers from their ways, computers and desks. Without proper diversity we are in danger of measuring the wrong things and most likely failing to address health inequalities.

Cultural change has to be about us being in, around and with our local communities – listening and understanding their needs.  It has to see a shift in attitude and behaviour – being open and accepting differing views and perspectives. We have to be able to see and touch those differences in the words, theories and practice – these are what will show that it is authentic change and demonstrate trustworthiness.  The transparency of actions can illustrate joint ownership and a sense of belonging for us all. These are all vital as we are increasingly using data and artificial intelligence.

I would argue that we need to create more spaces for us to have these conversations, that such places are about the opportunity for mutual learning – we learn about your experiences of and you learn about our experiences, we gain from each other’s knowledge and develop our understanding of new skills and greater understanding.

It cannot be the impact of your research – it has to be more about the impact on people’s lives and that can be best done together. The step changes are about improving our understanding about our communities, empowering local people which in turn enriches their communities, enthusing and encouraging young people, engaging with all types of media and become better communicators.

My question is…What is the giant leap that needs to take place to make this happen?

Links 

iHealth Facts https://ihealthfacts.ie

Community Scholars programme https://www.nuigalway.ie/ppi/case-studies/cesp/

START https://www.hrb-tmrn.ie/public-engagement/start-competition/

Evidence Synthesis Ireland mentor programme https://evidencesynthesisireland.ie/writing-for-communication-mentees/

Genes and Health East London http://www.genesandhealth.org

Manchester BRC 

https://www.manchesterbrc.nihr.ac.uk/public-and-patients/be-vocal-about-research/

Transparent Health Research – what’s in it for the public

Some personal musings on the engagement and involvement of the public and patients in the development of the Health Research Authority (HRA) Transparency Strategy from Derek C Stewart, a member of the Research Transparency Strategy Group.

Common Purpose

From the outset of being asked to be involved, I felt there was a strong sense of common purpose. The idea that research studies would be easier to find and that those who take part in those trials who get to hear what happened seemed irresistible. For years, I have heard the comments – ‘I took part in a study and never heard anything more’ or ‘where can I find information about what research is going on!’.

The fact that HRA wanted what the public, patients and study participants wanted seemed like a good cause to join, a worthwhile investment of time and a tantalising possibility of success.

Beyond the Patient Representative

My role, as a member of Research Transparency Strategy Group, was about bringing some knowledge more than my patient experience. It was about understanding the practice of involving and engaging the public more than ‘being the patient voice’ at the table. This seems to be about enabling a strategic overview of process of involving more than being the patient involvement representative. I felt it was more like observing and commenting on the purpose, process and practice – the final polishing.

I think this capacity can be divided into three aspects 1) Advisory – offering guidance and oversight; 2) Networking – making connections with other knowledge of work and through the use of social media 3) Practical – suggesting workable approaches and changes;

Authenticity

From the outset I sensed a genuine interest and desire for change from HRA. I mention this specifically as it was so clearly not the tokenistic gestures which hamper both effective patient and public involvement and improvements in healthcare.

The HRA had a sound recognition of issues around recording and reporting research They understood their responsibilities and their ability to inform and influence others to bring about change. This was clearly a partnership approach from management, the Patient Public Involvement Team, Communications and across the different offices.

They already had ideas, plans and had started work with partner organisations. This included the different nations, it was more than just London, there was a social media campaign, Local Patient Group. It was linked to other similar events and groups like AMRC and ABPI.

Public Expectation

One of the key drivers was the realisation that things need to change. There are so many more people taking part in research studies, it is becoming a greater part of the standard patient journey and the public has a greater expectation on receiving information. These are assisted by the increasing use of smart phones, tablets and other digital technology.

In many respects, this experience reminds me that this is about improving the patient experience. It is about having a clear understanding of what needs to be improved, changed or developed. Patient & Public Involvement can be a surrogate to ensure that all those who need to be involved have the opportunity; a reminder to have a rich mixed variety of opportunities for people to have their say; to work with partner organisations and groups; and to have plans which are appropriate and proportionate to the task.

Leadership

Another important strand, for me, in the way we meaningfully involve and engage the public, patients and carers is the value of capable leadership. In this case the joint leads of an executive and non-executive director demonstrated the Board’s commitment and were unified in the direction of travel.

By leadership, I mean working with people, having open conversations, checking and rechecking the assumptions, ideas and proposals. This was an enquiry-based approach, the various events rolled on from each other with alterations being made, text being amended as each conversation progressed.

It is about taking the decision to be transparent about transparency by publishing the minutes of the meetings. This may invite external criticism to our discussions, processes and suggested proposals but actually that’s what leadership is about.

Learning

On reflection as I think about the involvement as a whole, I appreciate the greater potential we have to be levers for change rather than solely the representative on a committee or working together. It is as much about challenging the nature of exclusion rather than becoming tied up trying to include everyone. It is about advocating for a wide variety of opportunities to engage and involve people in decision making.

It was fundamentally about clarity of purpose, a joint authentic endeavour and inclusive leadership to

  • Make transparency easy 
  • Make transparency the norm 
  • Make information public.

Finally

All of this is brought into sharp relief because of Covid-19. Research is in the public eye in a way that it has never been before. It is under greater internal and external scrutiny. By having such a number of ways to open the dialogue we are better able to understand the process and regulation of research and address fake news.

I believe that the HRA has become more known and more in touch with people as part of this process. I think it realised that as a regulator it really appreciated the willingness of people to help create, develop and make change happen.

I certainly found out more about health research, the role of a regulatory body and policy development.

Andrew George has written about how this is more than a relationship for the BMJ

Andrew George: Consent is only possible in a relationship

Thank you, Juliet, Andrew, Nicola, Teagan, Helen, Jim and Naho – apologies if I have forgotten anyone

Reading and Reviewing Research protocols and Participant Information Leaflets – Part 2

Ok! I assume you read Part 1 but as a reminder, this is mainly for patients and members of the public who have been asked to help researchers.

Before we start could we just place ourselves in the shoes of the researcher.

They asked you to comment on their work, probably without being too specific. We return the document covered in red pencil marks, underlines, words circled, notes such as “I don’t understand this at all” or a mass of track changes, score-throughs and comments.

How would you feel when you receive this especially if thought that you had really tried to write a ‘lay summary’? You felt that you had explained it in easy steps and avoid medical terms?

PRAISE SANDWICHES

I like Praise sandwiches! I learned about them as a teacher working with pupils experiencing problems ay schools. You begin by saying what you like about someone’s work, then point out something that needs improving and end with another positive. They are about leaving people with their self respect.

I always think that the writing of the lay summary and the participant leaflet are the most difficult things we ask the researcher to do.

Sometimes, when I don’t really know the researcher, I test out the ground. I review the document and then I select say the first paragraph for comment. I send it over with my thoughts and offer some possible changes. If the response is favourable then I feel I have permission to be more critical of the rest.

As I said in Part 1, I don’t think my job is to do it for the researcher. Note to researchers – be more precise in asking us to give positive comments, areas for improvement and a limited number of negative responses.

There are a number of sources of good information and tools to help us get it right together…

Top Tips for Researchers – The Academy of Medical Sciences has a great simple advice list.

Readable will quickly test the readability, spelling and grammar of your text and show you how and where to make improvements. You can copy and paste text to show results from a number of different readability calculators and gives average grade level.

Drivel Defence is part of the Plain English Campaign. It uses javascript and you can copy and paste text in. It will highlight long sentences and make suggestions for alternative (easier) words.

Make It Clear campaign is part of the National Institute for Health Research NIHR Involve to ensure that research is understandable. 

Easy Read is particularly good in helping make information more accessible for people who find it hard to read standard written leaflets.

REVIEWING

I have become far more demanding (in a pleasant way) of researchers who ask for help. I request a telephone call or online meeting. I want to get to know them as a person just as I want them to know me. I ask… What precisely do you want me to look at? What groups of patients have you spoken to already? I then start to thinks about other groups, research communities that might be useful.

Having looked at very specific pages in the Protocol, I then go through the whole document section by section. I am looking for other evidence of the patient – where else might they be contacted, involved and engaged in the study through regular updates, dissemination events, poster writing, on trial management committees, advisory groups, co-applicants, authors, etc.

I am reading and thinking about the ‘recruitment plans’ – are they practical? I look and appraise the costs allocated for involvement. has the NIHR Involve Cost Calculator been used?

PARTICIPANT INFORMATION LEAFLETS

I have deliberately changed the title from ‘PATIENT’ to ‘PARTICIPANT’ in this instance as a reminder that mothers who take part in midwifery research aren’t patients; health volunteers aren’t patients; mental health services users don’t see themselves as patients. If the leaflet says ‘patient’ and I don’t see myself in that way then I might feel excluded.

The vast majority of people who choose to take part in a study do so on a voluntary basis out of sheer altruism – the desire to help others. Many who don’t take part spend hours climbing mountains, doing cycle rides, running marathons, sorting clothes and other belongings for charity shops. All of us pay tax and put money into a charity tin.

The words ‘research subject’ always has invokes a red line. We are human individuals.

When I first started looking at these Participant Information Leaflets (PILs) I used to think that researchers had never studied English. The PILs tended to be one solid block of text with few paragraphs and written almost as a stream of consciousness. The smallest font was chosen to cram in the most information an a blinded RCT was just gobbledegook.

I find myself thinking more about how I feel being given this piece of paper. I am looking more at the structure and layout. I often suggest making it into a trifold leaflet, a pamphlet.

I want to see diagrams, pictures, timelines and illustrations that encourage me to read and ask questions. I want a contact name and address. I am now looking for how those who take part will be informed of the findings in line with the Health Research Authority guidance.

I encourage the use of bullet points, separate boxes, different colours and emphasis. It wasn’t until I came across Professor Peter Knapp at York whose research includes looking at these leaflets that I grew in my critical confidence.

This research on research or trials methodological research is something I now spend a lot of my time. If interested have a look here.

GIVING FEEDBACK

I mentioned the Praise Sandwich earlier as a means to liking, criticism the liking again, as a good way of offering comment on a researchers work.

You might like to suggest that the researcher talks directly with those who are most likely to benefit from the research. You might point them in the direction of self-help and support groups, online social media communities, individuals you have come across. Asking or pointing out any possible effects on specific groups who they may need to talk to.

I have found the following approaches phrases of some use: Have you thought about…; You might like to rephrase this section to make…; You could perhaps think about…; I was wondering whether…; I like the explanation and thought that a diagram might also be used to…; If I understand this you seem to be saying…

I shall leave you to interpret what I was actually thinking when I use these phrases.

GETTING FEEDBACK

One of the missing elements is about the actual difference we have made by adding our tuppence worth to the research. It is essential that we ask for and receive feedback about the IMPACT of our involvement

A NOTE ABOUT OUR RESPONSIBILITIES

Our responsibility in this capacity is simply to engage, contribute and respond within the timelines. We can also refuse the task if we feel unable to complete it. This is the same with joining a discussion group with researchers.

As someone invited to read, comment and review these and other documents, I think that respect is the absolute key. I ask myself what would I think and feel if I received these comments.

I also believe strongly that as I have been invited in to look at these papers, I have a responsibility to ask questions about those whose voices are not being heard. It is about asking the questions about basic health inequalities.

IN OTHER ROLES

There are however some other roles. We might become a member of either a general Patient Advisory Group or one set up for a particular study. We could become a Patient Partner with the Research team in the development of the Protocol and Leaflets and therefore mentioned in the protocol. Some have become co-applicants for the grant funding, co-authors and there is also a strong group of user researchers. The responsibilities increase according to the roles and what is expected of us in these positions.

LEARNING FROM EACH OTHER

Too often, we think about drawing upon our insights to help inform, influence and shape the research. Yet, the reverse also happens – we become informed, influenced and shaped with new knowledge, experiences and skills.

I did not expect to learn so much about research, science and my own health. I did not plan to be involved with some many different aspects of health. I did not consider that I would be writing articles and blogs.

I know that I am much healthier than I was 25 years ago. I learned from research that I should have listed to my parents and eaten more green vegetables and fruit. I maintain a much better lifestyle.

I have found out much more about my cancer and how there is more attention given to the cancer type rather than where it presents n the body. I am encouraged to hear from researchers about lab based science that might improve people’s quality of life after treatment in the future.

THANK YOU

I hope you enjoy meeting researchers and hearing about what they do for us. Of course, if we weren’t ill, they wouldn’t have such interesting work to do – thanks!

Reading and Reviewing Research Protocols and Patient Information Leaflets – Part 1

A few ideas for Patient Partners helping to inform, shape and influence health and social care research 

Start with a cuppa!

GET COMFORTABLE

The first rule has to simply be – get comfortable! A cup of coffee or tea to hand.

I look for the Lay Summary – it will be there somewhere. I still prefer to print of a paper copy of this page although I am getting better at using tools like track changes for reviewing.

These Lay Summaries are improving all the time! It is a very long time since I have seen the exact copy of the scientific summary with the remark – “I cannot make this simple!” Bless them!

Pencil with eraser

I like to use a pencil with an eraser as I change my mind – a lot! I have a quick read and mark lightly with an underline or circle of phrases I don’t understand.

I take another sip of my drink then read more slowly trying to avoid turning to a dictionary or typing into the computer the medical terms.

I have to remember why I am doing this and what my role is as ‘the patient’ (I could easily be a carer, service user or member of the public) is all about. I am there to provide an additional set of eyes and think what I might understand if given this to read as a study participant.

I also have to stay calm and relaxed as this can be a frustrating task (for the researcher and us). I breathe in deeply before my next read and promise myself a reward (biscuit or cake) when I complete this stage.

OUR APPROACH

I always have to remind myself that I am there to assist and help the researcher understand their work from my perspective; to ensure that it is about improving these pages so that they make sense.

It is not necessarily about doing the writing for the researcher – it is about doing it with them. Imagine your teachers just giving you the answer – “Please Miss, Please Sir – what’s the answer?” says the learner. “Here, let me do it for you!” say the teacher. If this is what occurs then ask yourself if any actual learning has taken place.

Reading and Reviewing these papers is fundamentally about learning from each other. I like to think about it as taking the researcher for a walk so that they get a sense of my experience and I get a sense of theirs.

OUR UNIQUE PERSPECTIVE

My experiences are much more than the events told in the order they happened. They are about me drawing upon and selecting the most appropriate moments for the study. They are about me reflecting and using these experiences to help the research improve people’s health and treatments 

My treatments (7 weeks radiotherapy on my throat) left me with few saliva glands so that experience makes me look for possible side effects, longer term problems and think about how research might make a difference for future patients. I move from bringing hindsight, to offer insight that might provide foresight.

It is right that we are involved in this way. For years we were the missing presence at the table, the missing voice in the room and the unaccounted – apart from being a statistic or just the research subject.

Involving patients and the public in research has had a huge impact on research practice and culture.

Our biggest advantage is not knowing the science, medicine, research and even when we do begin to understand, how we came through the door is so vastly different from the researchers who chose to be there.

I sometimes say that I have lived in another country happily for many years but it does not stop me being from a different place. It is what I learn from each of these that makes me who I am. However, it is much better to ask someone living in that country today for a current opinion.

I would therefore encourage many patient advocates to think about encouraging and promoting the involvement of patients rather than just being the ‘patient voice’ especially as they become so familiar.

In essence, it is those external eyes, the other and most recent view that provides the picture that is required.

SOME DEFINITIONS

I include these just in case there is any confusion or if you are just staring off on this task of reading and commenting upon them.

Protocol – This is the document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organisation of a clinical trial,) and ensures the safety of the trial participants and integrity of the data collected.

Patient Information Leaflet – This explains to individuals everything that will happen to them, should they consent to participate; it allows them to weigh up the risks and benefits of taking part; and it ensures that the information provided to them is fully documented from a legal perspective. All of the above should be achieved in as concise a way as possible, without compromising clarity.

Lay Summary – This is a brief outline of a research project that is used to explain complex ideas and technical and scientific terms to people who do not have prior knowledge about the subject.

Consent Form – This provides potential research participants sufficient written information to decide whether to participate in a research study or not based on an explanation of the proposed research and the nature of the participation that is requested of them. It is signed to witness the agreement to take part. 

EXPERIENCE MATTERS

Our experiences can add value to research in many different ways. It can ensure that the research question that is being asked is…

Relevant – Is this the type of study that meets the needs of patients/carers and therefore might they be keen to take part.

Understandable – Will the person being asked to take part be able to understand the language, structure, content, the medical terms, the jargon. This is not about simplifying the words – it is about distilling and crystallising what it means. It is far from easy. 

Possible – Is this a study that can you can imagine being done or might participants think it not practical in terms of how we are feeling.

Suitable – How does this study fit in with other aspects of our lives, the extra hospital visits, the tiredness, etc. 

Appropriate – Lastly, does it seem the right thing we should be doing.

These are all about reality checking, grounding the research in the real life circumstances that patients are in. That is what our experiences teach us and that we can bring to the table.

Of course, a researcher is perfectly entitled to hear everything we have said and still be of the opinion that the research is still important enough to be carried out. I just want them to explain why the is.

THE LAND OF RESEARCH

Many researcher carry out this work as an extra to their day job. It is a highly competitive environment with significant pressures. Gaining funding can take years. Research, unsurprisingly, has its own language, culture and rigorous methods. It is necessarily highly complex and complicated.

This can, at times, separate research into a separate bubble – an academic silo.

It can feel like you have entered another country but remember our role is to help them understand our experiences not for us to become like them.

GETTING STARTED

With a Research Protocol, I begin by flicking through the whole document and skim reading odd bits here and there. I am trying to get a grasp of content and where the different bits are. I am hoping to gain sense of the purpose, the layout of the document and which pages I will need to read thoroughly. I might get an impression of how much time it might take to review. I may want to delay but the likelihood is that the researchers wants it back later today.

I note relevant ‘patient/participant’ sections; actual mention of patients – i.e. the incidence/need, the reason for research; the Lay Summary; whether those who are intended to benefit have been actively involved already (rather than proposed in the future) and what difference that has made; I look for the costs for involvement and see if the cost calculator has been used; I look for the Patient Info Leaflet and the Consent Form if included.

I also look for aspects of inclusion, equality and diversity. In particular to see if this research might effect certain groups or communities. This now has greater significance since Covid-19 and the events surrounding Black Live Matter. It might also affect vulnerable groups, rare diseases, young people, sexual health, etc. See previous blog post on Inequalities

The UK Health Research Authority has very recently published its Transparency Strategy which requires research to be recorded and reported back to those who who took part. As we review these documents we need to ask how this will be achieved.

ABOUT THE RESEARCH

My next task is to understand the need for study. To see how clearly this is explained. As a learner, I am perhaps also looking to understand the science, the medicines and the research methods that are being used. Is it for example a quantitative study counting the difference or a qualitative study capturing the experiences? Might it have an element of both?

What might this mean for the participant? Does the burden of the being on the study outweigh the benefit?

It is at this point that I am beginning to highlight words, phrases and the way things are said with those headings of relevance, understandability, possibility, suitability and appropriateness.

Spoiled for choice

I have now reached the point where I begin the actual review but more of that later.

Time for a treat, I think…

PLEASE LOOK OUT FOR Part 2 https://involveddotblog.wordpress.com/2020/08/13/reading-and-reviewing-research-protocols-and-participant-information-leaflets-part-2/

Note: This was prepared in readiness for an Online Workshop at The Royal Marsden for Dr Markella Boudioni, Patient & Public Involvement & Engagement Lead

SOURCES of INFORMATION

About Trials in General

NIHR I want to take part in a research Study 

Clinical Trials at The Royal Marsden 

Challenging Inequalities in Involvement for Black and Minority Ethnic Communities in Research

I have asked at many meetings whether ethnicity data was being collected in health research often to be told it was too difficult or not appropriate. I have asked researchers about the potential effects of their research on health disparities and inequalities and received similar replies. 

I so wish I had asked more often, more insistently and louder

I am writing this in response to the comment by Cori ‘Coco’ Gaufe, the young tennis player, following the death of George Floyd and the Black Lives Matter campaign. Her remark strikes a chord… 

“If you are choosing silence, you are choosing the side of the oppressor.” 

Uncomfortable truths

The very fact that an extensive consultation carried out to involve and gather people’s opinion was excluded from the recent Public Health England report about the Disparities in the risk and outcomes of COVID-19 is in itself dreadful. The fact that this was about hearing from mainly black and ethnic minority voices is an outrage. 

Every patient representative, advocate and leader should be raising their voice on this matter. 

The Covid-19 crisis has also raised many other uncomfortable truths about Patient and Public Involvement and yet offers perhaps some rays of hope as well.  (See my previous blog post and this excellent paper on HRB Open Research)

One of the standard models of patient and public involvement has been placing patient representatives on committees.

It naturally invites people who are familiar and comfortable with contributing to meetings, agendas but we tend to come from a similar background. It often means that we begin to assimilate.

There is nothing ‘wrong’ with us, we are ‘the experts of experience’ and not ‘the usual suspects’ as sometimes described. We are not, however, representative of the whole community.

Covid-19 left us all behind as we waited forlornly to be asked our opinions so perhaps now is the time to begin to think differently.

Opportunity

I am now noticing that many small self-help and support groups are using the numerous online meetings to chat together. I am seeing a greater diversity in many of these online meetings than I ever did at face to face events. In the past we might always have wanted to meet in person but clearly ‘needs must’ and maybe it allows more people to get involved. This offers a great opportunity to reach out to engage groups and communities in research – especially as science and treatments are in the news. It, of course, risks excluding those without access to technology but at least it can be more than one or two reps.

Covid-19 is adversely affecting people from black and minority ethnic communities, older people as well as those experiencing other health co-morbidities. These are not the people who we generally see as patient representatives. Saying seldom heard, hard to reach and placing in the too difficult pile is not acceptable.

It is not just Covid-19. Research clearly shows that men with a black African and Caribbean heritage are more likely to develop prostate cancer at an earlier age. Those from a South Asian background are more likely to develop heart disease and diabetes.

This is about health inequalities and their causes. The Health Minister may not know about the Marmot Report – Fair Society, Healthy Lives and the recent review Health Equity in England but we should.

It is by understanding this that we become better informed as patient advocates and more able to make our case for change. It is also about inviting us to reach out and not just pulling people into involvement.

Leading lights

There are, however, strong examples of where people from these communities have been reached and fully involved in learning about their health, using research and taking part in studies. 

The  Genes and Health Study has successfully recruited 100,000 people of Bangladeshi and Pakistani origin in the UK. It has achieved this through community action and a practical approach to engaging and communicating – I wrote about Golden Hearts performance in 2017.

Katie’s Team works in the East End of London on research about women’s health. Their meetings discuss the realities of access to their GPs, their families and the challenges of research.

Prof Kamlesh Khunti, from the Centre for BME Health, is one of those leading figures asking for research into the effects on black and minority ethnic communities. His article on Covid-19 and Ethnicity sums up the need for research to change.

It is by knowing about these examples we can challenge the idea that it can’t be done. It is about learning from these examples that we all develop an understanding and competencies.

Involvement & Inequalities

Those who are actively involved in research need to constantly be asking more astute questions…

  • What have you done to ensure that this is a priority for patients and communities?
  • What has been done by the researchers to ensure that the communities this research is meant to address have been spoken with and their views taken into account?
  • What us already known about health inequalities in your area of research?
  • What ethnicity data is being collected with your study?
  • How are you planning to let all participants know the results?
  • Are you aware of the resources to help you reach out to members of the community?

                  How to engage seldom heard groups – a guide from East Midlands AHSN 

             Working with the voluntary and community sector – a guide from UCL

You may also find this series of articles from The Kings Fund about Equality & Diversity of interest.

Being clearer about the questions we ask and being able to refer to relevant resources helps to shift the balance of knowledge. It means we can think outwardly by visiting groups rather than inwardly hearing from a patient representative.

There is however a much deeper question which Meerat Kaur asked me which is about whether our current ‘representative approach’ prevents us acting outwardly. Meerat spoke about being informed in her thinking through twitter chats with Lynn Laidlaw and Eleni Chambers.

Learning from History

It is useful for us, as patient advocates in research, to find out and build our understanding about the past. I would strongly recommend reading about the following…

The Tuskegee Study is an extremely uncomfortable, clearly discriminatory example of research practice at its worst. Scharff and others describe how it is about more than Tuskegee in study Understanding Mistrust about Research Participation

The story of Henrietta Lacks is a further sobering example of the arrogance and abject failure to inform and communicate what was being done with human cells.

Some of the barriers to recruitment are explored in this article by Dancy and others Community Based Research

We may want to learn from outside health and see how people are trying to overcome the barriers https://reachingthehardtoreach.eu

Dr Petra Boynton has put together a superb Reading List which has plenty to get you started.

Knowing this helps us to understand about other people’s experience, ethnicity and cultures for mutual respect.

More Recently

The Mental Health Foundation provides a good summary about the importance of mental health for those from a Black and Minority Ethnic Communities – https://www.mentalhealth.org.uk/a-to-z/b/black-asian-and-minority-ethnic-bame-communities

The Lammy Review – provides an independent review into the treatment of, and outcomes for, Black, Asian and Minority Ethnic individuals in the Criminal Justice System. 

Much of what I have written apply to the many other health inequalities – for women, people with learning and physical disabilities, young people. Change needs to happen for everyone and it needs to be about addressing the causes as well as the effects. Thank you @ResearchNurseD.

Personal Thoughts – a few key moments

Growing up

I would like to thank Mr Cadogan who regularly came in to my parent’s shop, chatted away and smiled kindly at me – a little boy. He was the first black person I met. 

Later I read the book Black Like Me by John Howard Griffin. I have linked this to an article about the book which very much epitomises how I feel about it now. But, at the time it made a difference to the way I thought.

College

One of my lecturers, was Cecil Williams. Cecil had spent time under house arrest in South Africa after objecting to the apartheid laws following the Sharpeville Massacre. 

Annually, around the date of his escape he would tell the story of his break for freedom. For over an hour, as first year students, we were engrossed – the telling of the arrest, the planning of the escape, the risks, the near misses. I was shocked at the injustice, the audacity of his escape, especially when comparing the quiet, gentle, unassuming man who sat telling this story. He said little about what he had been fighting against, the people he was working with or the fact that his house arrest followed a period in prison. 

There is more about Cecil Williams at South Africa History Online. In 1998 a film about him was made called ‘The man who drove with Mandella’

Teaching

My life as a teacher was about using drama as a learning medium, it was often about exploring inequality, injustice and helping students understand and make their own meaning. It was mainly spent working with young people experiencing difficulties who were often excluded from schools in Glasgow and then later in Nottinghamshire. It was about finding ways to include them in learning activities. It was about finding things they could do, building self-esteem and giving them confidence in their abilities. 

Post Cancer

Many, many years later when I was involved with a crime reduction partnership in Nottingham, we were able to invite the Rev Jessie Jackson to visit the City. The statements he made and message I took were that this was fundamentally about democracy as well as race, ethnicity.  He commented on the need to see and hear ‘our likes’ on groups, committees and Boards to show democracy in action to act on equality. 

Finally

This is written for my grandchildren, their future and that of the many other young people who are raising our awareness of the need for change.

Thank you to Meerat Kaur, Shahnaz Aziz, Lynn Laidlaw, Eleni Chambers and others.

ADDITIONAL INFORMATION

Thank you to those who have provided information about other papers, writings and further sources.

https://onlinelibrary.wiley.com/doi/epdf/10.1111/hex.13078

Including ‘seldom heard views in research by Suman Prinjha, et al https://www.readcube.com/articles/10.1186/s12874-020-01045-4

David Lammy, MP, highlighted in a tweet that he made 35 specific recommendations in the Lammy review (pdf). He added that there are 110 recommendations in the Angiolini review (pdf) into deaths into police custody. There are 30 recommendations in the Home Office review (pdf) into the Windrush scandal. Twenty six into Baroness McGregor’s review (pdf) into workplace discrimination.

16th June – The Missing Report from Public Health England published after campaign by HSJ and others:

Click to access COVID_stakeholder_engagement_synthesis_beyond_the_data.pdf

Nasima BegumArpana Verma and Bella Starling have written an excellent piece for Manchester University on ‘How inequalities are affecting the response to COVID-19’ – http://blog.policy.manchester.ac.uk/posts/2020/04/how-inequalities-are-affecting-the-response-to-covid-19/

The Association of Chief Executives of Voluntary Organisations have produced an excellent report: Home Truths: Undoing racism and delivering real diversity in the charity sector

Jacqui Gath has rightly reminded me in a comment of the importance of the Protected Characteristics set out by the Equality Act 2010.

The National Institute for Health Research (NIHR) is looking to improve inclusion in all aspects of health research. Check out the Guidance Information

The UK Parliament has produced the Black Community Human Rights Report on the findings of research into people’s experience of health.

Patient Involvement in time of Covid-19

I have had a number of meetings and conversations over the last few months – since the outbreak of Covid-19. I think it fair to say that patients and members of the public who have been actively involved in the past feel that their voices are not being heard – reactions range from amazement, frustration and even anger.

These feelings are echoed by many charities, other organisations and by research teams who were similarly surprised at the lack of the patient voice.

Let me make it clear that this isn’t just about patients and the public being excluded and ignored – it was about the difference that such involvement might have made. It was about the fact that people were seeing studies that weren’t explained in understandable language, that used methods were perhaps inappropriate, had questionnaires that were far too long – the very basic things that are noticed and changed as a result of engaging and involving patients and the public. It is the essential the added value of external perspectives have been missed. This potentially results in a waste of public money, research effort and gaining a better understanding of Covid-19 that maybe means more lives lost.

I would like to unpick, if I may, some of the contributing factors that may help us reflect and think about in our discussion and what is needed in the future.

First of all remember it is a pandemic. It is life-threatening – our body and mind react often beyond our control. We revert to our base instincts and any training. My cancer may have been twenty-five years ago but I remember the closing down, the doing what had to be done, the importance of family, friends, colleagues – just trying to survive.

I think it is right to say that the medical community, researchers and clinicians reverted to base instincts and training – moving with speed, returning to standard emergency protocols and the raced to write research proposals for something nobody knows about and to seek funding. It is understandable but I still don’t think it is acceptable – so how should we move forward?ccc

There are perhaps a further 2 factors to bear in mind. 

Much of the initial research about the Pandemic was about science – laboratory pre-clinical research or non-clinical epidemic computer modelling. There are some examples of how patients and the public have helped inform research in pre and non-clinical research but they remain few and far between. I look to people like Dr Emma Dorris in Dublin and the Shared Learning Group in the UK to learn. But it is NOT an area where Involving Patients is widespread so that may explain the lack of involvement. It is therefore a time for reflection and subsequent action.

The second of these additional factors is that this was not a cancer, stroke, heart disease, Parkinson’s disease for whom there are charities, support and self-help groups – where there are strong and effective patient voices and leaders. Added to this Covid-19 is adversely affecting people from Black and Minority Ethnic communities who are few and far between in the strange world of Patient and Public Involvement. But in the UK during the AIDS/HIV period, there were exceptional examples of patients being involved with the science – why and how did the learning from this get lost.

So, what has been happening in the England

Practically

Strategically

The Academy of Medical Sciences – with the Association of British Pharmaceutical Industries, the Association of Medical Research Charities and NIHR – joint workshop with a report due soon https://acmedsci.ac.uk/more/events/patient-and-public-involvement-covid-19

But all of this doesn’t get away from the basic question ‘whose research is it in 2020?’ 

Public Funded Research (by taxation or donation) can no longer be the sole prerogative of academia, science or data managers – it must always have gathered the opinions, perspectives and challenges raised by patient experience, taken account of the patient voice, provide examples of how they have held meetings where patients have had presence and held influence along with actual evidence of the changes and impact that has had.

Ireland has a different approach – the focus is more on patient advocacy and empowering the patient voice – IPPOSI (Irish Platform for Patient Organisations, Science and Industry) provided a clear and unambiguous statement in response to the crisis – that the patient perspective is understood alongside the broader public health considerations to strengthening the mutual commitment https://www.ipposi.ie/2020/05/12/6159/

Health Research Charities Ireland https://hrci.ie/wp-content/uploads/2019/09/HRCI-Position-Paper-2019-1.pdf has rightly used research to find out what has happened to Patient and Public Involvement and also address the health needs of the population.

Ultimately, this is about more than just Trust. It is, to quote Dame Onora O’Neill, the philosopher, who says this is about ‘trustworthiness’ – Involvement provides the opportunities to illustrate trust in our behaviours and demonstrate it in our activities. This is especially required at the current political climate, the pandemic and in the coming years.

INTENT; IMAGINE + IGNITE

Impressions on Involvement in Ireland

I thoroughly enjoy my visits to Ireland – the people, the country and especially the conversations. I am interested in how Ireland engages and involves people with, in and for better health to improve health services and research. 

In Ireland, the involvement of patients and the public in research and health somehow seems more personal, more collaborative and transformative in its thinking and practice. It is becoming a pillar of good practice for quality research, services and care.

This post is my attempt to explore and identify some of the key elements that underpin what is happening in Ireland especially with health research. It also reflects a talk I gave at a Health Research Board, Ireland (HRB) lunchtime seminar early in March 2020. 

INTENT

The key differences between Ireland and the UK seems to be that of INTENT – the purposeful attention in Ireland to aspire and achieve change in the health of the population.

The approach taken in Ireland appears to be far more about improving people’s health and well-being rather than just getting people involved and providing support. There is an acceptance that the culture of research needs to be more focused around the needs of the population. There is a determination to encourage people to know more about how health research plays a part in people’s lives. There is a resolve to support patient advocacy and a greater understanding amongst researchers and scientists of the benefits of this commitment.

Each of these descriptions are fundamentally about thinking and learning – from and about each other’s experience, knowledge and skills. It is far from patients just being involved on a one-way street to help the research process. It is about reciprocity – a give and take with all sides – to learn and develop together.

Jerome Bruner, the educationalist, describes education as a two-way process and that we are never just filling empty vessels but sharing experience and knowledge. Bruner states that the goal of education should be intellectual development – the thoughtful process of learning from experiences. This aptly captures what I am seeing.

Ireland has thought carefully about its approach and seems keen to encourage everyone to learn and use health research – that it forms a natural part of both intellectual and personal development.

Health research in Ireland is doing just that by sparking ideas, developing people, changing institutions – all with the intention and prospect of improving health. The HRB are playing a vital role in making this happen through the HRB PPI Ignite programme. (May 2017). It has at its heart a sense of enquiry by inviting all to contribute, collaborate and share.

In Ireland, all of this is ably supported by the excellent work of the Health Research Charities Ireland (HRCI)  and the Irish Platform for Patient Organisations, Science and Industry (IPPOSI) *. Their leadership, partnership approach and support of patient advocacy are also instrumental in the increased focus on people’s health and wellbeing.    

In the UK, I feel we have used Patient & Public Involvement too much as the pursuit of an answer rather than opportunities for open enquiry. We have faltered in the procedural aspects of the development of a research protocol rather than the intellectual development of individuals, patients and professionals, with the joint pursuit of issues that matter to people’s health and wellbeing. 

IMAGINATION

“I was elected by the women of Ireland, who instead of rocking the cradle, rocked the system.” 

Mary Robinson’s quote reminds us of the need for equality and diversity, the desire to act differently and the requirement to sometimes disrupt the way things work. Ireland’s approach to health research is just that – imaginative, creative and gently rocking the system. 

The START competition, led by the Trails Methodology Research Network (HRB-TMRN) does all of these things (click on the word if you don’t know anything about it). START offers the opportunity for young people and schools to engage and become researchers.  (Currently postponed because of Covid-19 but you can still read about it).

Too often, the word research comes after the diagnosis of life-threatening illness when we are approached to take part in a study. Whilst we are trying to cope with a diagnosis, taking part in a research study is another thing to consider. It may even be the first time we have had to realise that our health services don’t have all the answers although Covid-19 has rapidly shifted that perspective.

START changes the order of things and moves the cradle of research out from academic institutions. It introduces research at an early age. Through START, pupils in schools are the researchers – choosing the question, running the study, learning about the importance of valid evidence. They are asking their own questions, learning about the precision required, potential bias and the importance of language and methods. 

These are the exploration of the high order skills in learning of hypothesis, analysis and interpretation; allowing young people to read with critical appraisal, to judge and challenge. This is Bruner’s intellectual development in action. You can read further here.

This isn’t something called ‘patient and public involvement’ – it is quite simply research for all, reaching out as opposed to a couple of patient representatives on a committee. It is research being meaningfully tried and used – in, for and by the community.

Whilst in Ireland, I met Prof Mary McCarron who has throughout her career worked with adults with intellectual disability with the IDS-TILDA study. Prof McCarron talks about how she has always engaged with those who are intended to gain from her research and their families. Such an approach is seen by her as being the most normal and natural thing to do.  It is not some ‘patient and public involvement’ – it is simply the sensible thing to do for good quality research. 

IGNITION 

I began my talk at HRB with W B Yeats quote that ‘education is about lighting the fire, not filling the bucket’. I had used it previously in Galway as it captures the central principle of collaboration that is so evident in Ireland.

The PPI ignite programme, from HRB Ireland, is such an inspired approach. It looked upon the existing good practice within certain initiatives and the work a number of people. A number of Universities were awarded PPI Ignite funds after submitting applications. 

It is an enquiry-based approach which is inclusive. It starts by asking the central question – what could we do to improve people’s health and wellbeing by involving the people of Ireland in matters of research? It advocates partnership working and asks a number of questions…

How can we build capacity? How can we meaningfully involve and engage members of the public and patients in the research? How might we promote interactions that are seen as fruitful and beneficial by both researchers and PPI contributors?

It did not set out to form a committee, fund central staff nor see it as a service. HRB became the host of a conversation, the educator inviting enquiry.

PPI Ignite illustrates, what I believe to be, a LEARNING CULTURE – from concept to operation. It does not advocate one single answer but accepts that there may be alternative approaches for different circumstances or contexts. This ignites people’s imaginations as a process of change rather than the product of a transaction.

Most recently, it has ignited The People’s Trial (funded by the Health Research Board, through the HRB-TMRN, as a Knowledge Exchange and Dissemination Scheme (KEDS) Award 2018). 

IMPRESSIONS

In my talk to the HRB I choose a few examples of where I thought they were doing things differently. I sought to identify the key aspect of the LEARNING PROCESS as well as the impact.

MUTUAL LEARNING – At University College Dublin, Elaine Quinn, the Institute Manager for Communications & Education at UCD Conway Institute of Biomolecular & Biomedical Research, explained to me about a workshop where researchers submitted their lay summaries for comment. These were then circulated to patient partners who took coloured pens to mark the words, phrases and layout they didn’t comprehend. 

The researchers and patient partners were then brought together to exchange knowledge and learn from each other. The researchers learned how to describe their work in lay language and the patients about medical terminology. 

Later, the Researchers were asked to present what they had learned from this experience which helped others think about how they might benefit from talking with patients and the public. This approach and the presentations helped reinforce the learning and helped the patient partners hear about the difference they had made. These workshops have since been rolled out in Cork and Galway.

SHARED LEARNING – The way people shared experiences was the second impression I gained. I had the opportunity to attend a lunchtime open surgery for researchers about patient and public involvement.  It was led by Michael Foley is the Research and Development Officer with the Trinity Centre for Ageing and Intellectual Disability (TCAID). 

The format of so many meetings and workshops is that the person working on patient and public involvement is that of telling people what involvement is about or doing the involvement on behalf of the researchers.

Michael as educator started from what the learners wanted to know and encouraged them to share what they had been learning. 

This was very much about researchers learning from each other, being ably facilitated by Michael. This was about the change taking place in the research community, hearing about how others had involved people in their research and the benefits they had gained. The learning focussed on involving people as an essential ingredient of good quality research not an added activity.

EXPERIENTIAL LEARNING – The final example, I gave, revolved around some of the work at NUI Galway I have seen from Edel Murphy, the PPI Ignite programme manager and leader of the organisation of their annual Conference.

This event (this year online) has patients using their health as the pivotal experience to improve research and patient outcomes. These ‘lightning talks’ were far more than just telling of the experience or about the process of involvement – they were about advocacy and improvement to people’s health.

It was at the Conference that I first heard about the Community Engaged Scholars programme which sets out to develop partnerships between researchers and community organisations interested in conducting research together that aim to improve the health of their community. 

This focus on community action means that the changes in health are more likely to be adopted by local people rather than taking one or two patient representatives on to a committee. 

Last year’s Conference was held, appropriately, at the NUI Galway Institute for Lifecourse and Society. The Institute supports applied research that informs policy development and practice to make a positive difference to people’s lives. It also excellent public transport links and parking. 

IN SUMMARY

These visits to Ireland and especially to PPI Ignite Galway confirm to me that it is health that matters; that engaging the public is about making research accessible; for people to use research evidence as means of helping their own care and that of others.

David Kolb, the educational theorist, defines learning “as the process whereby knowledge is created through the transformation of experience” (Kolb, 1984, p. 38). 

The clear intent in Ireland is transformational – to change people’s lives by trying things out, reflecting on the experiences, abstracting the concepts and then carrying out further actions. 

Patient experience is a valid starting point but it is ultimately how it is transformed to become a driver for health improvement that becomes the essence of change. We cannot just bring our experience to the table and expect change to happen. Patient and Public Involvement in Ireland is neither viewed as a service nor is it a one-way street. It is about the opportunity for the public/ patients and the professionals to learn rather than just about improving research proposals.

These are all about LEARNING as ENQUIRY – a joint exploratory process, a spirit of unity and cooperation – not a service or a product. 

As hosts of the enquiry, I suggested to HRB, they might like to think about certain questions in future…

  • Improving Health – what areas of health need to be tackled?
  • Leadership – why do some leaders ‘get; involving people?
  • Equality and Diversity – whose voices are not being heard?
  • Transparency – how do we increase openness?
  • Artificial Intelligence and Digital Technology – how are the public engaged?

Following trip to Health Research Board – 

The actual purpose of my recent visit in early March was to attend the Trinity Health and Education Conference Trinity College Dublin 2020 on Integrated Healthcare. I will be writing a complementary piece about a workshop I attended.

* HRCI is the national umbrella organisation of charities active in medical and health research.

* IPPOSI is a patient-led organisation that works with patients, government, industry, science and academia to put patients at the heart of health innovation.

Declaration of Interests

Derek Stewart has advised on the work at NUI Galway, has facilitated workshops at University College Dublin and spoken at Trinity College Dublin. He is on the Advisory Board for Evidence Synthesis Ireland and is also nominal lead for NIHR MRC Trials Methodology Research Partnership

What is Trials Methodology Research – a patient’s viewpoint.

Note: A report on Patient, Public Involvement and Trials Methodology Research can be read here.

Trials Methodology Research (1) is about looking at the way health research is carried out – i.e. improving the tools and trade of research practice. It is carried out by researchers often referred to as Methodologists.

These types of studies differ from doing things to patients – testing new drugs and treatments which can be described as Interventional Research. 

Yet, it is still research and needs to have a relevant question, an understandable proposal and lay summary along with all the other aspects of a study that can benefit from the patients’ viewpoint, an external perspective and a grounding in reality.  

Patient and Public Involvement has a place and the MRC NIHR Trials Methodology Research Partnership are a welcoming bunch of curious people. By ‘curious’ I mean in the pleasant ‘enquiring’ sense of the word. 

Why is Trials Methodology Research important for patients?

It seems to me (and I would really welcome other opinions) that the value for research participants are…

  • To see that the most effective research methods are being used to gather and understand evidence 
  • To be assured that trial methods are being reviewed, evaluated and progressing
  • To know that improvements and innovation are being discussed and implemented
  • To be certain that the methods themselves have been evaluated using highest quality research 

Trials Methodology Research, therefore, increases the likelihood that quicker and better answers might be found; data is used more effectively and efficiently; and, the way research is carried out is advanced. As a former teacher, it is the equivalent of having a thorough understanding about learning as well as the subjects we teach – the subtle difference between an educationalist and a teacher.

As patients, we have come to expect health research that rigorously tests out new drugs, treatments and care as part of a constant search for improvement of patient care. We are actively involved with researchers in these interventional studies. Such evidence that is gathered matters as much to us as the researchers. 

It is, in many respects, unsurprising that the same thoroughness is used to test the research methods themselves. It is ultimately, in our interests as patients, that we better understand why people choose to take part in studies, whether one method be better than another, and what are the best ways of analysing the data. 

Involving patients and the public in the sphere of Trials Methodology Research is increasing and we, as patients, may need to consider how to make this meaningful for research, for us and future trial participants.

Involvement with Methodologists feels like another stage in our learning about research. It is a bit like going to college after school (even if only part time). It becomes more about questioning the picture on the jigsaw box as well as the individual pieces. It is about helping to make research itself more effective and efficient to the benefit of patients.

Patient, public involvement with Trials Research is described by Alice Biggane (2), as helping “to increase both the value, integrity and quality of research”. These seem to be vital components for all research but particularly important for Trials Methodology Research especially as we look towards the greater the use of data, digital technologies and artificial intelligence.

I believe that our involvement with Trials Methodology Research also helps us to be more capable partners and advocates. It helps us step slightly away from our personal experience of health and think more of the concept of ‘patient’. Though our personal experience remains the driver for change, we begin to think in the abstract to make it better for all. It also assists with our knowledge of research practice and the things we don’t know. 

Patient experience, our voices and presence are needed to ensure the compass points in the right direction and that the realities of people’s lives are taken into account.

Source information

1. Definition: Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. Catrin Tudor Smith, et al

2. PPI in research: a reflection from Early Stage Researchers

Alice M Biggane1,2*, Maria Olsen2,3* and Paula R Williamson1

Actively Involving Patients/Public in Trials Methodology Research – https://www.methodologyhubs.mrc.ac.uk/files/5715/9016/6157/FINAL_2020513_TMRP_PPI_Workshop_Ver_2.pdf