Written on behalf of the Health Research Board – Trial Methodology Research Network, Ireland (HRB TMRN)* in support of the Medical Research Council + National Institute for Health Research Trials Methodology Research Partnership (MRC-NIHR TMRP).
Trials Methodology Research, what does it do and
why is Patient, Public Involvement important?
Over the past few years, I have become increasingly involved with Trials Methodology Research.
As a result, I am more certain than ever that the experiences, voices and insights of the public and patients are both necessary and essential with this type of research activity. To achieve this dialogue we need to be present at meetings, in discussions, attend conferences and see the activity mentioned in publications. Involvement with trial methodologists has the great potential to inform, influence and shape the way that the actual research methods are made better for patient care.
This relationship can bring about improvements in the actual studies by making trials more efficient, improving the experience of taking part and delivering research as well as speedier results. It is this form of transformational change to the research processes that is in all our interest. Ensuring that the modernisation of the methods are needed, relevant and acceptable becomes a key function of the public and patient involvement.
However, despite trial methodology sounding a bit daunting, a bit out of our ken, a little bit academic – my experience has been almost entirely positive, informative and enjoyable. These methodologists or triallists as they are often called are a welcoming bunch. For the most part they seem comfortable in knowing and accepting what they don’t know. Although we enter the discussion through different doors we find that we are often in the same place of wanting to find some answers.
It then becomes about what we all don’t know about issues such as recruitment, retention, rapid reviews, statistics, outcomes, adaptive studies, etc. It is about applying this common lens of working together whilst accepting our different starting points that helps each other understand the picture in front of us.
I may jokingly say, at times ‘my head hurts’ but that is mainly because of the detail of discussion, the precision of language but given time, I get there. The shift is that, it is not about me ‘the patient’ – it could be about any patients or not even patients. It is not necessarily about ‘taking part in a study’. It is about the methods of research being used. We are standing apart and looking at a bigger picture. But it is an interesting panorama.
How do I approach being involved with those in Trial Methodology?
I think that I can best describe this relationship, as opposed to working with clinical researchers through the metaphor of photography. Trial methodology looks through a quite specific form of lens and from a different angle.
As a former teacher using drama for learning, I would often begin by thinking about who the people in the story are most like – the phrase used in drama is ‘in the company of others’. It is a means of considering the roles that the pupils might take on and with whom they could be connnected.
If I was inviting young people to journey to the New World in a sailing ship then they would be in the company of explorers, travellers, adventurers. It would help me think of objects we might use – baggage, letters home, diaries and maps. These is turn would symbolically help to build belief.
It would also help identify the other people: those who have to carry the equipment, the botanists who might go along; the sailors tasked with getting them there – each providing different perspectives, possible starting points for different lessons as a means of looking at things from different angles. It would help me think of the questions they might have, the phrases I might use to deepen the experience and the consider settings to add tension – the unknown, the dangers, the opportunities.
When we look for these parallels and divergences, we can better understand what they do and consider some of their challenges, to gather other viewpoints, gain insights into how they might have felt and developed a more thorough understanding of their experiences.
As we move from our personal experience of ill health we hear from other patients and carers – this leads to us asking more informed questions.
Research as Photography
In this same way, we might think of RESEARCHERS as being ‘in the company of photographers’ (taking a number of images or snapshots of people taking part in the same experience at particular moments in time). This can be helpful for us as patients and members of public. It places research in a more understandable context. It helps us think of their world in a familiar way (Almost everyone has taken a photo at some point).
Photographers want the best and most appropriate images (some with the latest cameras and others with what is available).
Methodologists as Research Technicians
With this in mind, it is possible to view Trials Methodologists as being ‘in the company of those improving the process of photography’ (modernising the camera, improving the lens and shutter speeds, looking at how to take better pictures, thinking about lighting and tints, making photography available for more people).
Trial Methodologists are the specialists, the technicians, the artisans, the experts in specific areas. They are changing and transforming the way we plan and do studies, collect the evidence, determine outcomes and think about how to transform the method.
Evidenced Based Research Methods
Trial Methodology Research is therefore about gathering the evidence that shows that these changes are worthwhile. It is about trials and other well-designed studies that set out to ask the most relevant and appropriate questions that will help transform the research methods that might lead to better health.
It was a patient, who became a statistician, that questioned the way many doctors carried out their research and is seen as an elder of the modern randomised controlled trial for healthcare. Austin Bradford Hill wanted to study medicine but a period of tuberculosis meant that he took up economics and became involved with statistics instead. He established many of the statistical aspects of trials that we see today to ensure sufficient numbers, control groups etc.
Perhaps, this is one of the first examples of patient involvement. However, we don’t necessarily need to have been a patient though it can provide a useful experience to drive change. It is fundamentally about bringing a fresh pair of eyes yet a patient experience perhaps brings the particular sharpness to the focus.
The Finer Details
As the methodologists delve in complex fine detail, our other key role as patient/public, becomes about finding ways of translating this into clear language, pictures and diagrams.
This is, for the most part, not about our illness or any treatment. It is our understanding as a patient or member of the public that we bring to the table (i.e. we didn’t enter through the door marked ‘Research Career This Way’).
It is the insights we have gained about health and social care settings. It is our knowledge of how to find, approach and involve people in research as active partners and participants in a study. It is those other life experiences that guide our observations, advice and comments. These become the more refined understanding and wisdom brought by many experienced patient advocates.
Involvement with research methodologists is in many respects similar to the involvement with a laboratory-based researcher. We don’t need (or necessarily want) to understand the detail of the how they are going to alter cell mutation, know about the complex processes they will use and how it might eventually be turned into a treatment for a specific disease. It is again about the big picture, making connections and the fine detail gained from our knowledge.
The lab-based researcher finds it motivating to meet people affected by the condition they are studying; They find it useful to consider whether the medicine might be best tested in primary or secondary care. They see the need to explain their work in ways that is understandable.
It is always worth remembering that many of those who will review research proposals to decide whether it should be funded are not themselves specialists in the specifics of research methodologies.
Our role, as patients and the public, is to ask these researchers to explain why this might be valuable and what difference it might make. The opportunity is that we learn more about these fine details and develop more precise questions.
From a single photo, through family albums to social media
My family have a single photograph, we believe, of my great, great grandfather. It is small and printed on a metal plate taken sometime in the the 19th Century. We have collections in albums of homes, house and occasions.
Today, we all have probably thousands of photographs of the family, available on phones, posted on social media, sent as attachments, edited and altered using easily accessible apps. It is a more universal, open and accessible, as is research.
I still have no real understanding of how a smartphone camera actually works and nor do I really want to. Similarly, I don’t understand the detail in trial methodology. I do, however, know how to take pictures, edit them, post them and the technicians need that information, those insights and learn.
So, how do we encourage other patients and members of the public to become actively involved in aspects of health and care research methods to improve outcomes? Equally how do we encourage trial methodologists to open the doors to our involvement?