Monday, 30 September 2019

Patient, Public Involvement (PPI) in industry-led research – bringing charities and industry closer

A Guest Blog Post from Claire Nolan on important new guidance...

I am delighted and proud (as well as relieved!) to say that last week saw the launch of the Charities Research Involvement Group’s ‘Supporting Patient and Public Involvement in industry-led research: guidance for charities’. Developed and written with my colleagues in the group, I’m thrilled to have been lead author, especially as it was my first ‘gig’ as a freelancer. 
This is a much-needed guidance, which hopefully complements the brilliant resources already out there but takes a step by step, practical approach to helping charities in the UK with where to start when considering working with industry to support PPI.

The resource I wish we’d had…
Three years ago, as Research Involvement Manager at Parkinson’s UK, I started on my journey to understand how we could support the pharmaceutical industry to work with people affected by Parkinson’s to ensure their Parkinson’s research programmes were focused, sensitive and more likely to deliver better treatments, faster, to those people that needed it most. 
Through our PPI programme, we’d already supported over 100 academic research teams to work in partnership with 120 people affected by Parkinson’s in the prioritisation, design and dissemination of Parkinson’s research. But whilst we had this well- established, successful programme in place to support meaningful involvement in academic research, replicating that in industry-led research was another thing altogether.
The complex nature of medicines development and approval processes, the systems, procedures and risk averse compliance departments as well as the multinational nature of pharmaceutical companies meant that even knowing where to start was a challenge. So, we started from the beginning and spent a good year networking, attending pharmaceutical patient engagement conferences and trying to make connections in this mystery world!
We eventually connected with the UCB (a pharmaceutical company) Patient Engagement Lead for UK and together we worked to deliver patient involvement in two of their projects. 
Our experience of working with UCB was an incredibly positive one.  We worked together as a genuine team and the projects with them were examples of really meaningful PPI. But working with them was also complicated and time consuming, particularly with regards to the contractual process and internal approvals processes. We learned a great deal from our experience, and we wanted to be able to share that experience with others.
It is here that the stars align to bring about this guidance…
Through our Charities Research Involvement Group (CRIG) meetings we learned that other CRIG members including Versus Arthritis, Asthma UK and Autistica were also starting to work with industry to support PPI. 
So, in July 2018, CRIG worked with the Association of British Pharmaceutical Industries (ABPI), to bring together pharmaceutical companies and charities to discuss how we could collaborate more to support PPI in research. An insightful meeting which, among other priorities, confirmed the need for a ‘how to’ guide for charities to understand how they could collaborate with industry to support PPI. CRIG committed to producing this guidance and in April 2019, as a new freelancer, I worked with CRIG members and some PPI contributors who had experience working with pharma to outline what the guidance should cover and then over the last five months have worked with those same charities and PPI contributors to produce it. 
I hope that charities new to this area will find it useful, and I’m more than happy to discuss the guidance with any charities who are considering working with industry to support PPI (
Thank you to Derek for allowing me to gate-crash his blog and a big thanks to Bec Hanley and CRIG for the opportunity.
Claire Nolan

Note:The Charities Research Involvement Group is a collection of almost 40 charities who come together to share experience and best practice as well as tools and resources for supporting PPI. For over 10 years, members have work ed together to improve quality of PPI in research. For more information about CRIG, contact

Thursday, 29 August 2019

Taking Part in Research - a relationship?

pint? Have you gone raving mad? [...] I mean, I came here in all good faith, to help my country. I don't mind giving a reasonable amount, but a pint? Why, that's very nearly an armful!  (Extract from The Blood Donor - Hancock's Half Hour)

In good faith?

Tony Hancock’s portrayal of a blood donor still resonates today. Donation, that selfless act of volunteering to help others. After almost 60 years, since the broadcast, is it time to redefine the relationship, particularly as it applies to health and care research? 

The concept of giving in itself implies receiving yet at times it may still feel, as Hancock observes, more like taking. This seems especially true in health and care research despite many robust efforts to make it more of a partnership. Too often, people take part in a study and never hear another word about it. Should this transaction become more of an on-going and transparent relationship?

Being clearer and more concise?

Over the past few months, I have been involved with the Health Research Authority helping to develop their Transparency Agenda. I am a member of the Strategy Group and have attended various meetings and a number of the #MakeItPublic workshops. The consultation is now finished.

In this context, Research Transparency has four key elements:

  1. Registering research
  2. Making the results of research public
  3. Letting research participants know about the results of the research
  4. Making data from studies available for further research.

I want to concentrate on the third element - letting research participants know about the results of the research. One of the commonest complaints from research participants is that they took part in a clinical trial and never heard anything further. In today’s world that looks like poor manners and may even seem unfair.

More than just the results

As the weeks have passed, my thinking has developed. I have begun to question whether it needs to be more than just informing those people who took part in a research study. 

There are a number of factors influencing my thoughts. Medical advances in recent years have meant that many people are now living longer as against a time when research was often seen as something that took place at end of life. Smartphones and other digital technologies gave us instant access to information and enable communications which were unimaginable a few years ago. Thirdly, the public frame of mind has become more exacting in our expectations and rights.

In the past few years patients have changed from being seen as the subjects to being partners, actively involved with researchers. We have moved from just raising funds to being active supporters engaged in many different aspects of medical research. Trust has become a major factor with those who give to medical research charities. We have also raised our expectations of how we wish to be dealt with in many other aspects of life.

Interestingly, one of the most pleasing comments from research participants is just how many are touched when a researcher does actually keep in contact with them and how that made them feel informed and included. It was seen as a lovely thing to do - of  good practice. These are matters of common courtesy, decency and in some respects as good ‘customer’ relations.

A Mutual Relationship

For health we are dependent on each other. Without our illnesses, conditions, diseases and ailments there would be little to actually research. Perhaps the whole consent process should be redefined as a two way procedure where, as participants we sign to join the study and the researchers sign as to the ways we can be kept informed? 

This, for me, comes down to mutual respect and a better understanding the research practice and experience. It may be worthwhile reflecting on Mahatma Gandhi’s saying - customer is the most important visitor on our premises. They are not dependent on us. We are dependent on them.

It is about knowing what we can expect, whether we will have the opportunity to receive updates on the progress of the study. This will be, I believe, be of importance with the development of Studies Within a Trial (SWAT) as people might be keen to hear about other research.

I am not suggesting that all the information about a study is revealed for all. 
It does not mean the actual evidence, the latest findings or any internal interim results. Transparency is about being distinct and clear. It is not being see-through.

Keeping in Touch

The first time I came across the good practice of keeping in touch with people who took part (healthy volunteers and patients) was the study on the Long term impact of screening on ovarian cancer mortality - the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)

They produced a Thank You card which simply acknowledged their gratitude and set out the key facts from the study. It was informative, thoughtful and touching.

Some researchers are using digital technology like Cloudy with a Chance of Pain whilst others have set up either closed or public Facebook Groups.  For example the ALPHA Eczema Trial posts regular information about trial registration, public workshops and where the trial leads are speaking through their Twitter account @LICTR_Alpha and website

This is about being more open and keeping in touch. It is not about the trial results. I am talking here about information as to whether the trial has recruited the numbers of people it needs, how fast or slow this is taking, whether the team is looking into other similar areas of research and if they want/need patient insights.  

What might the relationship look like?

High quality peer reviewed research is necessary to improving wellbeing and healthcare. It requires rigour, time and to able to be reproduced. It does need to follow not however need to be entirely done in secret.

It seems to me that in a time of misinformation and distrust we need to focus more on being more open and transparent. We need to develop greater understanding of each other’s perspectives and come to some form of clarity as how we communicate with each other.

  1. TRUST is a key factor. The importance of doing research with people not to them. It is why the whole movement to actively involve patients and the public is so vital - it provides opportunities to ensure that research is relevant, appropriate and suitable.

Trust is gained by explaining why the research is important and acknowledging the contribution made by the participant - that recognition and thanks. It is also about a cultural attitude that conveys the value of learning. You can read more in this BMJ article about being Research Active.

  1. UNDERSTANDING is at the heart of the words informed consent. 
 is at the heart of the words informed consent. 

This is the importance of a good Lay Summary and Patient Information Leaflet - especially when these have been written by people affected by the condition and checked by members of the general public. It is the mutual gain from the exchange of knowledge and experience on both sides that helps us all understand.

  1. CLARITY around what, when, how and where information about the study will be made available. This should be the expectation of every study participant along with choices about how they wish to be kept in touch. 

I now believe that we have to consider that trial participation is as much about an agreement, a more equal relationship between research and the public - a commitment to each other.

Finally, a request

I also know that there are many researchers who keep in touch with those who have participated in their studies. There are many trial participants who have welcomed this contact and others who have helped prepare the lay summaries.  

Do you have any good examples to share? Please post examples using #MakeItPublic

Thank you Malcom Babb for drawing my attention to the lay summary of the results of thDe-ESCALaTE HPV Study which clearly states - Written by Patients for Patients. Thank you Dr Marianne Piano, who informs all her study participants at their final visit they'll hear from me again in the new year with a dementia-friendly postcard laying out the study results and what's happening next.

(which is now closed)

Please Note: Derek Stewart is an advocate for patient voice in health and care research. He is a member of the HRA Strategy Group and a Member of Cancer Research UK

Monday, 8 July 2019

Keep Up to Date on Data

Some interesting articles

There have been a number of interesting articles recently, I thought it might be good to curate some of these in one place. It seems really important that in the world of Patient and Public Involvement in Research we keep ourselves up to date on data.

*useMYdata, is a movement of patients, carers and relatives supporting the use of personal health data. They are great source of information and have a series of Patient Advocate Stories (1) 

You can sign up for regular updates by emailing:

If you are new to all of this then Understanding Patient Data (2) is a good place to start. 

It explains why, how and what Patient Data is used to improve diagnosis, care and treatment.

They produce some really helpful YouTube animations and other information.

The Association of British Pharmaceutical Industry (ABPI), The National Institute for Health Research (NIHR) and the Association of Medical Research Charities (AMRC) held a Panel at their Pioneering Partnerships meeting

This article, about the event, is a timely reminder that it is about people. (3) 

Health Data Research UK (4) brings together those working and interested in the thinking and practice of use patient data. They have a Public Advisory Board. Their News and Features is worth looking at.

The Wellcome Trust has just announced significant funding of £75 million in health data. 

Just as the above article talks about people so Wellcome stresses the need for trust in their announcement (5) about the purpose of this investment.

The National Data Guardian, Dame Fiona Caldicott is calling for a public debate on the future relationships between the NHS and those innovating using patient data (6) This follows the results of a poll of over 2000 people.

Of course in all of this, it is really important to give the sources of the data when reporting on research. Where did the data control come from AND have we thanked the patients? The UK Data Service provides a useful shortYouTube clip Cite the Data. (7)

There are many big issues at stake here and I found the comments in this article from Open Democracy (8) a useful guide to the opportunities and risks.  

Websites linked above

1. Use My Data:

2. Understanding Patient Data:


4. Health Data Research UK:  

5. Wellcome Trust Funding:

6. National Data Guardian

7. UK Data Service:

8. Open Democracy:

I have written other posts on data on this blog and another piece was in the NIHR website 

Sunday, 12 May 2019

Reaching OUT to involve Communities with Health Research

I love #WhyWeDoResearch 

It is, quite simply, an excellent example of REACHING OUT TO INVOLVE COMMUNITIES WITH HEALTH RESEARCH -

           For more on this very topic, follow the Tweetchat 13th May 2019 1200-1300hrs

@ClaireW_UK looked beyond her day job, asked how the health research community might be brought together using social media then just went ahead and did it. Gathered a few friends, began a few Tweetchats, then a number on a single day to a veritable smorgasbord of dialogue. Read more about the campaign in the BMJ here.

The great, the exceptional and the unique #WhyWeDoResearch TweetFEST 2019 took place from Mon 13th May for two weeks. Check out the # for all the tweets.

Reaching out to colleagues, linking it to International Clinical Trials Day and encouraging others to host the conversations. It is led by the community and guided by Claire. It is whole community from research nurses, researchers and patients to research organisations, industry and leaders. It is WORLDWIDE. It is vibrant, exciting and fun.

The breadth is amazing - two full weeks this year - make sure you bathe your hands, do regular exercise and add some hand cream to keep your fingers agile and supple for full-on tweeting.

It is therefore a privilege and an honour to be kick starting #WhyWeDoResearch TweetFEST 2019

How do we do more to REACH OUT to involve communities in health research?

This question lies at the heart of work I am doing with communities and colleagues in Nottingham. Nottingham University Hospitals Trust is a research active hospital and keen to see health research as a driver to improve health, wellbeing and social care. Our Nottingham is Research Strategy sets out our ambition.

Our enquiry led approach helps us to constantly ask….

  • How can we do more to help improve peoples lives through health research?
  • How to we go beyond waiting for the person to arrive at clinic and work with communities to use health research?
  • How might patient and public involvement to reach out rather than selecting a few people to attend health research meetings?
  • How do we ensure that research evidence reaches out to change practice?

These will form the basis of the Tweetchat but let me offer a few examples…


I was recently in Galway, Ireland for their Annual Patient & Public Involvement in Research event. It seems right to highlight a few examples of how they are Reaching Out. It is part of the Ireland Health Research Board - Ignite PPI.

First of all the event was help in a venue with easy access by public transport (next to the park and ride) at the Institute for Lifecourse and Societyat National Universities of Ireland - Galway (NUIG). The Institute supports applied research that informs policy development and practice to make a positive difference to people’s lives. A cafĂ© on the ground floor invites you in.

Read more about the @PPI_NUIG conference

Reaching out with Schools

They have a brilliant way for schools learning more about Clinical Trials through the START Competition - Read more at  and watch an Introductory video here START Q & A Session (05-02-19)

A further initiative is through Evidence Synthesis Ireland @EvidSynIRL where they are keen to make Medical Research findings need to be more accessible. They have engaged the journalist @muirishouston as their Writer in Residence - you can read the article in The Irish Times.

Finally from Galway, they have been working with the Medical University of South Carolina’s (MUSC) Community Engaged Scholars (CES) Program

Dr Carolyn Jenkins spoke at the 

It will be really interesting to watch how this develops as it firmly about partnership working,

And if you thought it might be difficult to Involve people in science the you should read Dr Emma Dorris and colleagues here


There is the amazing Cloudy with a Chance of Pain which uses our smart phones to access meteorological data to help understand arthritis. 

There is the equally amazing, Genes and Health - East London and Bradford  with over 37,000 people giving consent but with so much more going on to transform people's lives.

And, yet another amazing example, Harvey's Gang showing how even complicated science can be communicated

You can watch the presentation - here

You can read more about some of the ways patients, carers and the public get actively involved in pre and non clinical research in a previous yet on-going post - here

Sunday, 3 March 2019

What are the difference between some aspects of Qualitative Research and Patient/Public Involvement?

What are the difference between some aspects of Qualitative Research and Patient/Public Involvement? 

NB: If you can come to read about Knickers to Involvement, you will have to read the whole post ;-)  

I struggle to describe and define the difference when asked this question at a workshop. I fall back on the easy response of referring people to the joint HRA/Involve paper. Putting my thoughts done here was initially prompted by a conversation with Kristina Staley and Bec Hanley. We just met for a chat over coffee and that conversation set us all thinking and these ramblings. 

PLEASE READ Kristina's Blog where we are trying to set out our thinking in a chart

Please use #QualitativeandPPI when responding on Twitter

As for my thoughts….

I suspect that it is an exercise in how little I actually know but I always find that seeing the printed word helps to clarify my thoughts. It allows me to hopefully apply some logic to unpick the issues. As with virtually all I write, it is an attempt to enquire - the purposeful use of a question in a search for sense.

At the outset, I should indicate my commitment to Qualitative Research is almost unbounded. I consider that it provides valuable evidence about people's opinions, attitudes and experiences of healthcare. I believe that all clinical trials that have a qualitative element have a greater potential to provide a broader understanding to help make better clinical decisions. I am therefore, I suppose, biased.

The practices of both Qualitative Research and Patient Involvement have their own place in developing of improving people’s health and wellbeing. I would like to suggest that for the most part they are fundamentally different, yet at other moments they are almost joined seamlessly. They may even at times occasionally collide. 

Let me start by seeking to illustrate what I believe to be the difference. 

Sharpening the Research Question

A researcher may set a question based on validated qualitative evidence that requires further enquiry. It may be seen by the clinical and academic community to be the valid question to ask and therefore worthy of enquiry. Peer review may support the hypothesis that subsequently leads to a successful funding application.

Patient Involvement, however, can often give a more nuanced view about the research question. It is about how the question is phrased, the subtleties of tone in certain words.

I have heard researchers say that by involving patients and the public that their question became much better. The changes proposed by actively involving patients and the public have been about making the questions sharper, more pertinent and precise to the needs of those who are the intended beneficiaries of the study. These discussions are rarely about changing the actual question or telling the researchers what to study yet some researchers see this as a genuine concern.

Patient involvement is firmly in the area of the ‘personal’ - the distinctive added value, driven by direct experiences. Qualitative Research seems to provide a synthesis of opinion.

But where does Patient Involvement come together with Qualitative Research? 

The Unanswered Questions

The use of the James Lind Alliance - Priority Setting Partnerships enables patients and researchers come together to identify any unanswered questions. 

These partnerships gather the separate views of patients and researchers. This joint nature of this endeavour makes it then difficult to see exactly where the line between the two falls. I am not sure this matters as it is the outcome of identifying the areas that need further research that are most important.

Let me offer another example focusing on a particular practical task...

Personalising the Patient Information Leaflet 

We, patients and researchers equally, want Patient Information Leaflets that provide accurate and helpful advice about a study.  

Qualitative research can provide useful evidence about what makes a good Patient Information Leaflet. It can ask for people’s views about how they might like to receive information. These studies can provide useful advice about content, layout and format. Yet, this qualitative research is often general advice and less study specific.

Patient Involvement can give advice that is about the individual study. It can suggest the use of different words, changes in tone, alter the layout to make better sense. It is about the ‘personal touch’ from people who experience and know about the condition/illness being researched. 

There is a strange dichotomy here that I, as a patient advocate, know about the work on Patient Information Leaflets, yet many researchers I work with don’t. Qualitative research can therefore inform and influence patient involvement and the latter‘s knowledge can inform about the value of this work.

Peter Knapp, a senior lecturer at York, states that there is no evidence about whether this leads to more people taking part in studies yet it feels morally right and reassuring that patients have had a say in the development of the research.

This personal perspective and moral compass can be replicated in adding value to inclusion criteria, recruitment, analysing data and in the way research is disseminated. 

But, how else might we work together yet retain our separate perspectives?

Patient as Partners in Qualitative Research

I had the pleasure of attending a workshop in Nottingham where a researcher wanted to ensure that the work identified areas of genuine importance to patients, which researchers might miss when running focus groups.

She and colleagues ran a half-day introductory workshop on the qualitative method they were using which everyone found highly informative, enjoyable and useful. One of the patient reps then sat in on the focus group, which was seen to draw out a deeper understanding of patients real concerns.

The qualitative researchers are still qualitative researchers giving that professional viewpoint. The patient partner is still giving the patient perspective and able to identify a phrase or attitude that reveals a truth. By working together they each add value.

Words have Different Meaning

I have heard and read much about the attitudes of people affected by cancer to the word ‘battle’ being used in articles and conversations with patients. It seems sensible therefore to avoid using a word in a leaflet that might upset or even offend someone but how will we know without having those conversations. 

You may also have noticed that I just used the phrase ‘people affected by cancer’ rather than patients. I use it because it is more inclusive of relatives, friends and colleagues. I was a cancer patient almost quarter of a century ago - I am not now. It is these subtle changes that sit within all health domains, are prevalent across all professions and exist in all relationships. 

Involving patients and the public is that opportunity for a reality check. It is on the grounding in real life understanding. It is the application of common sense. Paul Workman, from the Institute for Cancer Research wrote about this recently.

A Summary

Qualitative research is rightly about standing back, observing, gathering and analysing the evidence to offer comment. Patient Involvement is more about stepping forward to speak up from a personal perspective. Meeting each other and working together for mutual understanding and making research personal. It is about mutual gain from a relationship.

Qualitative Research is clearly about ‘evidence’ whilst Patient Involvement may be more about the ‘individual’ but each brings and provides knowledge. It seems to me that it is as incumbent on patient advocates to know about qualitative research as it so often relies on their experiences and provides backing for our discussions. It is a chance to learn about the different methodologies that are used from questionnaires and surveys to narrative analysis. 

We can understand why people take part in but it was many patients who asked for a Patient Research Experience Survey about what taking part is actually like. We will want and need qualitative research to review, analyse and give evidence about the types of questions, the responses achieved. But sometimes it is about the poster on the wall, a mis-worded phrase that lacks the personal sensitivity and empathy.

And finally

A person may choose to buy and wear clothes to make them feel that they are reasonably keeping up with fashion but the views of their close family and friends can give opinions that are both immediately practical and apposite. They may be kind or maybe difficult to hear yet they stop us looking ridiculous. 

There is a part of Patient/Public Involvement that can say the Emperor has no clothes when those working in research may be more conscious about their careers.

There was a wonderful quote on Twitter recently that Involving Patients and the Public "might reduce the chance of the researcher making an arse of themselves". 

If that is correct, then I wonder then if Qualitative Research may be more about saying what type of knickers we prefer to wear. But is it Patient Involvement that can really say which knickers are the most comfortable?

PLEASE READ Kristina's Blog where we are trying to set out our thinking in a chart

Please use #QualitativeandPPI when responding on Twitter