Where next for patient involvement in research ?

A very welcome editorial in the BMJ will I hope give greater strength to the growing movement for provision of patient involvement in research.

I have been an ‘involved patient’ for 16 years. In the early days getting to understand research was the first challenge, we had no training available to us. Our professional research colleagues could hardly be more welcoming but were actually confused about how to handle us, could not recognise situations we could help with, and sometimes could not even handle the questions we asked. So we learned together.

There were a few enlightened researchers and leading doctors in those early days. It is almost unfair to pick two out for comment but they were outstanding in their recognition of the issues and in the way that they addressed them. Professor Sir Mike Richards, the first National Cancer Director, and Professor Peter Selby, the first Director of NCRN and later what is now NIHR CRN. Both realised that what they were changing was a process and that it would take time. We all wanted it to be quicker but there is an inertia in the affairs of man which means that changing established cultures can rarely be rushed.

There was a lot of pressure in the early years to demonstrate the ‘value’ of patient involvement as an intervention. By assessing its direct impact on a research project through something which may be as simple as a consent information sheet, the hypothesis was that the impact must be measurable. This question is still heard in Europe, voiced by research communities who do not want, for whatever reasons, to recognise the role that patients can play. Such assessment requires some kind of baseline against which the changed outcome can be compared. Most attempts to describe the impact of patient involvement in these terms have been trivial at best and laughable in many cases. Publication in a peer-reviewed journal is noticeably hard to find.

Patient involvement in research is about changing the processes by which research progresses. It does not change the science, although questions raised may cause design modifications by the scientists, but it modifies the environment – the timing, the nature of discussion, the emphases placed at different times, the interactions between team members etc. It will also bring in a different consideration of the impacts on patients entering the study, the ethical boundaries, the nature of communications with patients, and can play a part in deciding about data analyses and the promotion of results.

Even in the UK where patient involvement is now almost ubiquitous in healthcare research, this difference is not fully understood. Many research groups pride themselves on patient involvement which is in fact quite trivial, They involve patients in reviewing patient issues raised by their studies, reviewing consent information, sitting on Trial Management Committees, but have resisted a deeper involvement in the whole research process. That is their next step.

This puts an interesting burden on the researchers who are in such partnerships with patients. They must start to more consistently integrate their patients in everything they do. They must also report their subjective responses to these partnerships and the way they evolve so that we can build a picture of value which can help the more recalcitrant recognise the importance of involvement. We, the patients, cannot do this alone.

I welcome steps such as this week’s announcement by the BMJ that from next year it will not only require researchers to report on their patient involvement activity but also on the dissemination of their results to patients.

Every bit as important is the growing reach of the Biomed Central journal Research Involvement & Engagement. RI&E is the only peer-reviewed journal dedicated to papers on patient involvement. (I declare an interest – I am on the Editorial Board).

The moment is right for the debate about patient involvement to widen and develop on an informed basis. We have to find the mechanisms to create a common understanding of where we are today, the different models of involvement, the perceptions and expectations which we have individually and collectively based on the experiences we have had, and the reports of innovative practice and clearer thinking which have come through in the publication of papers on different implementations. We have the opportunity to define an agenda which sits comfortably with the research community and which can be implemented pragmatically, ultimately for patient benefit.

There are some underlying ‘big’ issues to address as well. One is how can involved patients hold their research partners to account, should that be necessary. Another thorny issue is should involved patients be remunerated in some way and how can this be done without conflicting with their independence.. Even if some of these issues cannot be answered they can be clearly defined and understood. Maybe some form of guidance can be offered. Contributions to the ongoing debate would always be accepted by interested journals.

Despite these complications the underlying rationale for patient involvement in research is simple. Research is a collaborative activity which should maximise quality by including representation from all those with a stake in it. The (over-used) patient mantra, ‘nothing about us without us’, probably applies here more than anywhere else.

A Challenging Month

I don’t often write about what I have been doing, more about what I am thinking. But June into July has been quite a month.

I joined the ECCO Methods in Cancer Clinical Research Workshop in June. This is held at Zeist in the Netherlands, not far from Utrecht. It used to be held at Flims in Switzerland, an extraordinary venue, but increasingly inaccessible and costly in these days of austerity. I enjoyed six year at Flims from 2007 to 2012, as the only patient on a faculty of 40 supporting 80 Fellows attending the course. The pattern is similar at Zeist. I had the real pleasure of working with 40 of the young oncologists developing studies. It was demanding and called on all my knowledge of cancer and of being a patient, whether that was developed from personal experience or from those who have shared their experiences with me over the years.

Coming home called for a rest. However my blood pressure medication needed adjusting and I was becoming increasingly unhappy with the actual medication itself. It seemed to be causing hazy periods, lack of concentration and increased fatigue. However I was also getting increasingly chesty, with a tightness on my breathing. Then on Wednesday I fell. I had my amputation over ten years ago and have never fallen since. Until now. How it happened showed how woolly my thinking had become. I failed to complete the fitting of my prothesis properly and walked out of the artificial leg. Gravity took over. I landed on the stump, the pain was excruciating. No breaks, just some severe bruising and a few scratches. Spent the rest of the day recovering and started moving around again the following day but I was getting more and more breathless.

By Friday morning I was an emergency admission to hospital in Shrewsbury. After various tests and discussions it was decided I had nothing more complicated than a lung infection and after 60 hours on oxygen, some strong antibiotics and a valuable review of my cardiac functioning I was released home on Tuesday. See earlier blog.

Thursday was my cancer follow-up. Different hospital, the Robert Jones & Agnes Hunt Hospital in Oswestry, and because it is a specialist orthopaedic hospital which does not handle medical cases the contrasts could not be greater. In addition the new cancer unit which was only opened last year is a pleasure to visit. I know the team well, they have treated me too often, and they are doing some really good pioneering work on, for example, nurse-led triage. All OK and I was grateful for a careful review of all the imaging of my lungs from recent days. It is now five years since my latest treatment but with my chequered history of recurrences I am continuing in follow-up.

Two moments of special pleasure. The hospital has started a bio-bank, so I was able to sign up and offer more tissue for research. Then they told me they had acquired a new consultant surgeon and introduced me to her. The surgical team now has more female surgeons than male, a situation I could see coming but did not expect so quickly. It has been one of my true pleasures in 16 years of patient advocacy to see the shift in oncology away from male dominance. It is also evident that women are bringing new ideas into research and it can only work to the benefit of patients.

Back home, no more appointments. Still not right but getting better every day.

Testing the NHS – unwillingly

A lot is written about the NHS and its problems, which are undoubtedly significant, but not enough is said in praise of what happens on the front-line.

I have put that to the test this last week.

On doctor’s advice we called 999 (the emergency number) and requested an ambulance. I was short of breath and it was getting worse. A short triage process on the telephone but even so within ten minutes two paramedics were at the door. A few tests, lots of questions, a phone call to the doctor and within 20 minutes I was in the ambulance, breathing oxygen and on the way to hospital.

A 5* score.

A&E was busy. I did not expect to be quickly seen but within 20 minutes I was on a bed in a cubicle. There is clearly a protocol for people with my symptoms and the young nurse explained what she had to do – take blood.  However getting a canula into my arm proved difficult and it was probably ten minutes later before she got what was needed. Then a more experienced nurse took some arterial blood – that was painful. Through it all every kindness was shown and I genuinely sympathise with the young nurse’s inexperience even though I still bear the bruises. We all have to learn. Round to x-ray for a chest x-ray.

A 4.8* score.

Along to a ward, clearly a room used for very short term admission until a more permanent bed is found. An ECG. Young registrar gave a cautious immediate diagnosis – never saw him again. Nice young man. After a couple of hours along to Ward 32 Short Stay. Business-like welcome, insistence on getting oxygen into me, vital observations, fact checking (yes I am diabetic), and with an outside temperature of 29 degrees apologies for the lack of air-conditioning.

Overall a 4.9* score. Only spoiled by the fact that no-one told us that the first ward we went to was an interim situation. It was a single room with its own bathroom – the only time I saw a private one. Shame.

Saturday to Tuesday morning was the tedious bit of finding out what was wrong and sorting it out. The oxygen was clearly helping breathing recover. A CT scan eliminated the possibility of a blood clot and identified some fluid and an infection. Antibiotics, a change of blood pressure medication, discussion with consultant about the heart (ectopic beat, some enlargement)(you knew I was big-hearted) and all the time a steady improvement.

Definitely a 5* score but for the lack of air-conditioning.

But how was I treated? I cannot fault the care of the staff, both for me and the others in the four-bed bay I was in. The younger non-qualified staff were without exception superb. Real empathy, gentle humour, high quality intervention (eg when I forgot to put the oxygen on), and prompt response to situations that arose. They were under-staffed, most shifts down by at least one person it seemed. Most of the qualified nursing staff had the same caring approach, with one exception whose memory colours the whole experience.

I am happy with a 5* score because despite the one exception they were such a strong team they worked around her limitations.

Discharge on Tuesday was unnecessarily prolonged, largely because of delays at pharmacy. It was explained why pharmacy was having a tough time and it seemed that this was the major impact of the current resourcing problems on my stay. From the time the consultant said I could go to the time I actually went was 7 hours. Even this little experience must have placed pressures on the NHS, one problem leading to another etc.  I won’t give a score for discharge.

So what does all this add up to?

Grateful thanks for first class care and admiration for the attitudes and behaviour I experienced. In the context of the whole NHS I have little doubt that my experience can be multiplied thousands of times every day. It is the reality of a people centred system where the real work is done by people at the front-line who care. It is their problems we can solve, patients will benefit from that. These wonderful young staff must be supported.