Pressures are building on patient advocacy

Two pressures are building on patient advocacy. We do need to draw a line here between patient advocacyand patient involvement. The former are patients or professionals working towards a specific objective such as getting a new treatment approved, or raising awareness of an issue amongst politicians. That can be correctly called advocacy. Patient involvementis the drawing in of patients with ‘lived experience’ to a structure so that their experience based input, whether considered or ad hoc, can be taken into account alongside other views. There is of course no clear boundary line, partly because the same patients can be doing both. The two terms can be confused and issues which apply to one can also be inappropriately applied to the other.

What are these two pressures, and why are they unique to theadvocacyagenda?

The first is the influence of pharma companies, the funding they provide to patient charities and the influence that the funding opens up. There are regular, sometimes well informed, articles in both professional journals and the wider press raising concerns.

These concerns are real because recent history shows us what can happen. One example was a breast cancer charity that accepted funding for a policy post which actively promoted that pharma company’s drug to politicians and created patient activity supporting it. Quite often funding was sheltered through a local PR company.  Matters became more subtle in the mid 2000s and funding related to ‘projects’ rather than core activities. One not unusual ‘project’ was funding charity staff to attend an educational conference at a foreign and very pleasant venue, all costs covered. Regulations which required openness about funding followed and pharma companies now declare who and what they have funded in great detail. Charities have no such regulatory requirement from the Charity Commission although many do declare what they have received and for what purpose. Some healthcare charities will not accept industry funding at all and declare that policy openly. It is not tidy and while this lack of openness remains there will always be critics eager to point fingers at one or the other party.

Where this becomes an issue is with regulatory affairs. Patient groups and charities are often asked to provide an input to regulatory discussion, usually a paper, sometimes representation at meetings. Questions about financial influence are part of the preparation and a declaration of potential conflicting interests is requested. Some regulators are less searching than others.  Charities all have a different approach to completion of these requests and I do not believe that any regulator has a requirement that the CEO must sign the declaration.  Understandably charities which have little or no involvement with industry find these forms tiresome, not always understanding their purpose. The aim is not to eliminate input but to provide a perspective which reflects the real-life of working with and supporting patients. I have spoken with regulatory committee members who tell me they weigh up what is put forward by patient advocates at a meeting, taking into account the declared potential for conflicts of interest, but not discounting the input provided.

It is time matters were tidied up. The Charity Commission could regulate how charities declare commercial grants in their accounts and charities themselves could carry a declarations page on their website, as some already do. The regulators could work together to have a common declaration approach and individual advocates should make declarations (already required by some regulators) so that their personal situation is clear.

If there was this kind of clarity pharma company lawyers might be able to stop twitching so much and make the matter of financial support where it is proper, appropriate and open happen more easily. In addition researchers or journalists who get a ‘bee in their bonnet’ about inappropriate influences could be quietened, although I doubt they will ever be eliminated and, to be fair, the questions need to be asked.

The second advocacy influence is about understanding evidence-based medicine. It overlaps with the first issue above because some pharma companies could be accused of fostering a preparedness to ignore evidence. More about that in my next contribution to the debate.

 

 

SOME THOUGHTS ABOUT THE NHS LONG TERM PLAN

I do not suppose that I am alone in finding that as far as cancer is concerned the NHS Long Term Plan, published on Monday, is admirable if somewhat underwhelming and, to be fair, cancer is only a small element in the whole. Its primary focus is on diagnosis.  There is no mention of the loss of valuable skills caused by Andrew Lansley as Secretary of State for Health in 2010-12, although work on Cancer Alliances to mend the damage proceeds.

The paragraphs on cancer in the Long Term Plan start with the following:

3.51. Cancer survival is the highest it’s ever been and thousands more people now survive cancer every year. For patients diagnosed in 2015, one year survival was 72% – over 11 percentage points higher than in 2000.

As a general point that should be borne in mind, even if NHS idiosyncrasy was not taken into consideration, evolution in clinical practice would account for much of that improvement. Indeed it can be argued that if progress on the 2007 Cancer Reform Strategy had not been politically diverted we would be showing even further improvement.  Things have obviously moved on and while not all of the 2007 ambitions were achieved the NAEDI National Awareness and Early Diagnosis Initiative, led by Cancer Research UK for the last 10 years, has been critically important. It identified many of the factors which result from the behaviour of patients, GPs or the wider NHS, in the diagnostic process and it underpins what is now planned.

The NHS Long Term Plan has these promises.

Assuming that full funding for these developments is forthcoming in practice and that staffing issues for radiographers, radiologists, pathologists, laboratory staff, nurses and oncologists of all kinds are addressed (given the effects of the B word) this will be a very welcome development and will go a long way towards meeting the cancer survival ambitions.

There is however a shadow, identified in the Health Foundation report Unfinished Businesspublished shortly before Christmas. This is the role of GPs as ‘gatekeepers’. Those with undiagnosed cancer rely on a GP having suspicion and initiating tests (the right tests) or making a referral. That will not alter although the frustrated will be able to self-refer to a Rapid Diagnostic Centre. These will certainly pick up some of the otherwise undiagnosed but not all. Indeed there will be some who attend a Rapid Diagnostic Centre who may not be diagnosed early – a small percentage of false negatives come from almost any test, there are always interpretation issues and some rare cancers have barely discernible characteristics at their early stage.  So from a patient viewpoint this is a welcome step forward but quantifying its potential is massively uncertain and success will rely on the skills levels available in the Diagnostic Centres, especially those located at a distance from a major cancer centre.

3.52. This Long Term Plan sets a new ambition that, by 2028, the proportion of cancers diagnosed at stages 1 and 2 will rise from around half now to three-quarters of cancer patients.

In 2007 we could not have stated an ambition in those terms. This target comes from the work that has been done on data, initiated in 2007. The National Cancer Registration & Analysis Services is a world leader in cancer data. In each tumour type the push to record staging data at diagnosis in the initial cancer registration is resulting in a much more accurate picture of prognosis at diagnosis. This can be compared with the eventual treatment outcome and also provides for targets such as this one.

The NHS remains excellent at creating ambitions while overlooking some of the issues. There are two things evident in the NHS Long Term Plan. First, it is not a plain English document.  Second it did not involve independently minded patients in its development but we have now come to expect that. Patient involvement has been reduced to tokenism in NHS cancer service provision. It cannot be described as patient-centred any more and a key weakness of the whole structure is that the voice of end-users is missing. The charities, good as many of them are, are not a substitute.

On the matter of creating ambitions while overlooking some of the issues I find it hard to believe that a faster diagnosis standard for sarcoma will emerge without resourcing specialist sarcoma units to handle it. Pathology skills, one example, are already at a premium. Over 50 primary diagnoses, with many variants by location, histology and surgical feasibility, suggest that words like “all” and “full”, which appear throughout the new plan, could be unrealistic. The case for genetic profiling to take over the challenge has no evidence base and apart from profiling the whole population I cannot see it working for sarcoma. I should like to be proved wrong.

IN SEARCH OF CLARITY

There have been some thoughtful blogs recently on the subject of PPI in research from Simon Denegri (headless chickens) and Jim Elliot (mis-selling PPI), and an excellent editorial in the BMJ on evaluating PPI in research.  It may be time to put forward some of my thoughts about what is not happening and perhaps should be.

Patient and Public Involvement is too generic, the term is too imprecise, to allow it to be other than a mantra for ignorant management to follow.  It is difficult to implement unless those charged with actually doing it really understand what it involves.  As a result Jim’s dislike of the PPI abbreviation is widely shared by cognoscenti and those organisations which thoughtlessly perceive it as a route forward find themselves in Simon’s headless poultry farm. To cap it all after twenty years the research community still questions its value.

So if it is too generic how do we break it down? The immediate thing to do is to separate ‘patient’ and ‘public’.

Being an involved patient means bringing the “lived experience” of a disease or treatment to the table where it is relevant to have that experience available and expressed. In research this need is easily identifiable and a general public involvement is not required. For some roles you need a patient, nothing else works. Simple. Hmmm …

When you go beyond research into the more general arena of healthcare the public voice is important but the involvement of patients is also a need.  What that means is that a large overall part of generic PPI activity is actually about public involvement and the involvement of patients where a research focus is not present. However having patients involved is a management mantra (“look how clever we are, we are patient centred”) so there are contradictions and political expectations to be met.

The National Standards published last year call it all ‘public involvement’.  That distorts it. Research has specific needs .  Sadly these Standards point towards lowest common denominator corporate behaviour, the NIHR ignored my consultation suggestion of having a standard about senior management being actively engaged (over and above signing it off). That is what Simon is now calling for. Evaluation plays no real part in the Standards and that need is well described in the BMJ editorial.

So we have management mis-understanding, inappropriate pressures on front-line managers, lack of terminological precision, lack of ambition, conflciting purpose, no meaningful feedback about performance. Yet, we want more of it. Confused?

The general healthcare need for public involvement is about engaging the community, whether geographical or a community of interest which the organisation serves.  Recruiting, training and supporting public members is different from the processes for recruiting patients to be involved in research.  If there is a specific need for involving patients outside research (eg developing a new therapy suite) these can usually be easily handled because there is a local community involved.

My personal wish is to see the research issues sorted out. PPI in research is focussed on the “lived experience”, first-hand experience of a disease or treatment, and importantly patients are sought for what they can bring as individuals, not just because they belong to a defined community. They can be harder to find and, for example, ensuring that a rarer disease is represented can be all but impossible.  Inevitably this means that there are roles and occasions where a more generic experience is valid but putting in a member of the public solely because they are a member of the public is not appropriate.

We must manage these separate needs separately even when all these requirements may co-exist in one organisation. It must be recognised that they are different and should be managed in different ways.

I am sure that understanding this difference and recognising separate approaches according to need could help Simon’s chickens grow into fine oven-ready birds. Clear ideas about evaluation would probably help. As for a replacement acronym for PPI, assuming we cannot have an acronym-free environment, I give up. Identifying these different purposes will perhaps give focus to evaluation efforts, allowing us to develop involvement with a clear idea of how value can be recognised in all its different purposes.

Footnote: I recognise that there are some situations where the only way of tapping into the “lived experience” is through those who care for or lived with a patient. In these instances the carer’s “lived experience” is valued just as the patient’s would be.

 

https://simondenegri.com/2018/12/11/public-involvement-is-beset-by-headless-chicken-syndrome-in-too-many-organisations/

http://www.drakesyard.co.uk/have-you-ever-been-miss-sold-ppi-why-it-matters-how-we-refer-to-public-involvement/

https://www.bmj.com/content/363/bmj.k5147

 

NHS Cancer Performance – a helter-skelter of political incompetence

Heigh ho, its off to work we go. Those dwarves in Snow White had an enduring philosophy of hard work, tempered by compassion. I think their approach is mirrored by today’s cancer advocates, whether from professional or patient ranks. We have to speak truth to power, whether that is a wicked witch or a Tory government.

This government’s attitude to cancer stinks. It is now getting better after eight years of disinterest and decline. No doubt when challenged the government will point to new money arriving, they will not record the fact that performance standards are now lower than in 2012 when those standards were last revised and accepted, by them. Most of those standards repeated what had been in place for many years already and had been measuring the success of the policies and practices put in place by Professor Sir Mike Richards, the first national cancer director. The Coalition government had been in power for two years by 2012 and the disastrous policies of Conservative Secretary of State for Health Andrew Lansley (now ennobled) were beginning to bite. He was sacked in 2012 but the policies did not change.

This decline will continue, possibly for several more years. It takes time to turn the tanker round (another misplaced metaphor). It took time for the tanker to go off course in the early years of Tory rule because there was great momentum. The loss of the Cancer Networks in 2012 destroyed the NHS’s ability to learn and adapt in small ways, the dispersal of experienced staff with extensive knowledge into other roles wiped out a major resource. The recent invention of Cancer Alliances will hopefully correct that mistake but it will take time for the expertise to rebuild.

We have also seen major steps forward on such issues as early diagnosis. Sir Harpal Kumar’s Task Force produced an excellent report which the NHS accepted. What is not in the report is a recommendation that hospital operating capacity needs to expand to cope with more people being diagnosed earlier. The austerity-led reduction in capacity, seen by waiting lists in almost every surgical discipline, is impacting on cancer treatment targets and will continue to do so, possibly for years.

Maybe politicians did not see the linkage. Cutting nursing numbers impacts on areas such as surgical recovery, intensive care and theatre staff. Without the proper safe staffing levels surgery cannot take place. Closing one operating theatre for half the week so you can use what staff you have left more efficiently extends waiting times. What chance do performance standards have then?  At the same time improve diagnostic procedures in primary care thus increasing referrals into secondary care, and you extend the queue at the other end.

The equation is clear. One good + one bad = all bad. Sorry Harpal.

Increasing cancer resources with more surgeons or oncologists will not solve the cancer waiting time issues. It requires a major overhaul of staffing resources down the whole chain of treatment increasing the capacity of the NHS. It takes three years to train a nurse to staff level, and then further training for specialist care. At the very moment when we are about to exit the EU and possibly lose access to a major staffing resource, what chance rapid improvement?

Talk about screwing it all up. How to kill people invisibly. We made huge steps forward in the early 2000s. The now largely forgotten report by Professors Sir Ken Calman and Dame Deirdre Hine in 1995 records what cancer care was like then. We may not sink back to those standards but 2004, here we come.

The raw Performance Data is here

Excellent commentary on the data in the Guardian

PS: a real delight to see and have a chat with Sir Ken Calman at the NCRI Conference last week. Enjoying his role as Chancellor of Glasgow University where he first became a professor in the early 1980s.

In search of creative input for PPI

Patient and public involvement in research has been gaining a lot of attention in the professional journals recently. I am not sure whether this is a turning point or just a matter of coincidences. It seems that either researchers have woken up to the idea that this is an area where research is needed (it is) or that it is where opportunities lie for writing papers which enhance their CVs.

The paper which seems to have been written solely because it could be written, yet offers nothing to our understanding of patient and public involvement, could be called futile.  However, a paper which is has futile conclusions is not necessarily a bad paper, it may just point to a shortage of evidence. The paper which predictably has futile conclusions, even if the methodology employed is well-validated and robust, should be identified by peer review and rejected. The pursuit of futility is not science.

One problem here is that peer review in most professional journals rarely uses people who work in, or genuinely understand, patient and public involvement. The journals just don’t know who they are and most cannot be bothered to find out. So the chances of a reviewer challenging a paper as having little or no value is small. Usually such papers are sent to methodologists to review, a task they will relish, grist to the mill so to speak.

One of the reverse problems in patient involvement is that a good paper seeking to identify new understanding will be criticised by the methodologists because there is a lack of evidence to support its creative thinking. The lack of evidence is because researchers have not sought it. It can be partly attributed to the fact that creative understanding of patient involvement by those who do understand it is rare, and the ideas on which good research can be built are not aired publicly because journals will not publish them.

Quite a challenge!

We have recently seen a paper looking at “synthesising conceptual frameworks” for PPI in research. It is a commentary by methodologists on a systematic review first published in 2013 which put forward such a conceptual framework and identified priorities for research. The commentary is highly critical of the earlier work and goes on to state; “…this critical appraisal has usefullyhighlighted that there is a continuing, even urgent, needfor a more rigorous synthesis of conceptual frameworksfor PPI.”  The commentary offers no ideas about further research, suggesting that its authors actually know nothing about PPI, confining its suggestions to a need for “more robust conceptualisation” of  PPI frameworks.

From the viewpoint of one involved in patient and public involvement this verges on self-justifying nonsense. What PPI in research heeds is more people getting on with it, professionals and lay people working together.  Our ‘frameworks’ need to be created, reviewed, changed, evolved, reported, and all done in a timely way so we can all learn together.  Conclusion noted, this paper adds nothing. There may be other viewpoints but from that of PPI this was a research paper written for the sake of it. I hope it looks good on a CV.

Contrast the approach of another recent paper, also a critical commentary. It looked at the NIHR Standards published earlier this year. The Standards are seen as a step forward but many limitations are identified. Some are “simplistic”, even “optimistic”, and there is a need for guidance which can make implementation relevant to the objectives of PPI in any organisation or situation.  The conclusion states that the Standards: “… fail to address fundamental questions about when, why and with whom involvement should be undertaken in the first place.”  It goes on to add :“By addressing the justifications for patient and public involvement up front and acknowledging that there are contexts in which some types of involvement are inappropriate, a future version of the Standards or another guidancedocument could provide researchers with the overarching clarity they need.”   Here is some real value-added.

Both papers are addressing the need for better understanding of PPI based on good evidence. I would maintain that we must not be confined by traditional evidence-based approaches.  This is not about medicine but is about people.  We need to develop research ideas through creative understanding of what is happening and what has happened in the world of PPI in research, through understanding the people involved.  If we are to move forward effectively we need those creative ideas to help researchers identify where evidence about PPI can add value, to help develop the new ‘frameworks’ – they will start conceptual but require practical experience so they can become real.

That will keep up the momentum which PPI is developing.

The two papers referenced:

Synthesising conceptual frameworks for patient and public involvement in research – a critical appraisal of a meta-narrative review    David Evans, Noreen Hopewell-Kelly, Michele Kok and Jo White   BMC Medical Research Methodology (2018) 18:116    https://doi.org/10.1186/s12874-018-0572-0

National Standards for Public Involvement in Research: missing the forest for the trees     McCoy MS, Jongsma KR, Friesen P, et al.     J Med Ethics Epub ahead of print: [accessed 12thOctober 2018]      doi:10.1136/medethics-2018-105088

Patient Involvement and the Push for Technology

Our new Heath Secretary, Matt Hancock, owns up to being a technology enthusiast and he is already pushing some technology ideas even though the knees of his trousers can have barely touched the underside of his desk.

I often refer to the lessons of the past. Where technology in the NHS is concerned the lesson of NPfIT needs to come to mind. This was the ambition of connecting all NHS patient records and making them available on demand in every GP practice and every hospital. The National Programme for IT started in the early 2000s and was cancelled by the incoming Coalition government in 2010 by which time, a later parliamentary analysis showed, it had cost over £12bn.

What were the lessons?

It was a simple ambition. However no-one could specify it and the core principle for developing a big IT system is that there must be a specification. Technical requirements regularly changed, contractors came and went, some were sacked, enthusiasm grew, cost extensions were agreed by Ministers unquestioned because the ambition was so good. It was all top-down. A few sample GPs were asked what they needed to do their job effectively. Patients were not asked about having all their clinical data gathered together, they were told what was planned and asked to agree (I went to one of those meetings). Voices raising concerns about data privacy were not listened to. Voices raising concerns about the ability of the IT industry to deliver the scale of ambition were just scare-mongers – even though some of them had impeccable IT credentials.

Today’s IT implementations are dominated by apps and small computers (also known as smartphones). It is about putting “information in the hands of the people”. If they use it – success; if they don’t – failure. Costs are minimal and there seems to be a queue of potential providers willing to invest. So what’s wrong with that?

Nothing, if some underlying principles are observed.

First principle – specification. Any app which the NHS agrees to use must have an agreed specification with data portability and security probably top of the list.

Second principle – implications, which will be derived from an independent impact assessment. At the top of the list is clinical safety. And then there are the structural issues. For example an app aimed at working 20-35 years olds in a local area could change behaviour patterns and affect resourcing. Provision of those services to other age groups may deteriorate. Success can be more damaging than failure, it may create demands on the NHS which are difficult and costly to meet.

Third principle – patient involvement. This is less about “will patients use it?” and more about understanding the issues which patients will face while they are using it and having used it. This avoids ‘top-down’ thinking. An ongoing patient group (not a one-off meeting) which actively questions the developer should be an important pre-requisite for NHS approval.

Fourth – the rare situation. Anything clinical, relevant to the app, must be dealt with. It is no good having a remote GP system which fails to investigate a possible sarcoma, and it is no good triggering an investigation and overloading the NHS when a clinical examination (which cannot be done by an app) might deliver a diagnosis. This kind of situation is not uncommon and is not limited to diagnostic work. So called artificial intelligence can offer a lot but it is not the answer to everything – it has no hands.

Fifth – beware the hype. Anyone predicting cost savings in a marketing presentation is talking rubbish. There may well be savings but they will take time to deliver and will not reach anywhere near the scale that enthusiasts predict. Similarly anyone predicting volumes of take-up without having patients already advising them is talking through their hat.

Sixth – sustainability. Do not deal with anyone who has no certainty of being able to deliver their service in two or three years time. Anyone coming into health provision in this kind of way must be able to deliver over time.

Having a list like this might seem like building bureaucratic hoops for an entrepreneurial app developer to jump through. But, think hard.  Every one of these points is about the patient. It is not in the patient interest for any of these points to be avoided. It may be that enthusiasm and opportunity seem dominant for an enterprising Health Secretary but patients are at the heart of this.

Matt Hancock may be seeking a culture shift in the NHS towards greater use of small and large IT systems which can resolve some of the gaps in NHS service provision, open up new opportunities, and improve patient experience and the outcomes of treatment. However you cannot ‘put the patient at the centre’ of what you are doing if you do not involve patients in that development.

Involvement is not a single person, not a single meeting, not a presentation to a group. It is about active and ongoing engagement which allows patients to listen and understand, then relate their personal experience and the experience of others from whom they have learned, to a proposed development, to consider implications, to engage in conversations, to visualise, to use their common sense natural abilities to help deliver something which can benefit other patients.

 

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.

In praise of the “consumer” – Part 2

What should patient representatives and advocates be called? Perhaps it should be something closer to what they actually do, rather than a bland generic term, such as ‘consumer’ or ‘research partner’. However, are there terms which can cover it?

Perhaps it is useful to describe a hierarchy of involvement. The most effective people at any of these ‘levels’ may not be the obvious ones, it all depends on an individual’s character, life experience and desire to help with the task. The hierarchy is something along the following lines, nothing is exclusive of anything else:

  • ad hoc single-meeting consultation, work on Patient Consent Information
  • regular association with a research group, university research unit, or clinical trials group contributing to a range of studies
  • serving on trial management group or IDMC, participation in study analysis, management of involvement
  • review of funding applications, performance review, panel review of research programmes, organisational board contributions
  • strategic involvement in policy, development of inter/national guidance, board level interaction

There are no value judgements in this hierarchy.  An involved patient may be quite happy working at the first level and could be contributing in a truly valuable way. Similarly, others could be working at several ‘levels’ at once. However, if a requirement appears which can be definably anywhere in this hierarchy it should not automatically be assumed that any patient could handle it.  A properly judged decision on the kind of experience needed and on offer should be taken, and it might need care and tact.

We also need to think about the kinds of impact which can be made by involved patients. The truth is that the infrequency of patients involved at the two lower levels in the bulleted list reflects the potential for greater impact, and the fear that can be associated with unpredictable challenges and demands. Reality shows us that this fear is unnecessary in a well managed and regulated organisation. Twenty years ago that fear was manifested at the top levels of the list as well, but has now dissipated with time and experience. This gives us a clue about the real impact of patient involvement. It is not about an ‘intervention’ which makes a difference (big or small) in one study, or one programme, it is about process evolution. Patients affect the tone and fashion of a meeting, their input in working groups shapes things in slightly different ways, their eye for different detail picks up things which can be modified beneficially. It is subtle, some might say insidious, but it works.

The patient representatives and advocates who recognise this and work at it are possibly the most effective over time. They are change agents, though of a kind not usually described in management theories.

So, back to the question, what do we call them?  I am stumped for a term or terms.

I will settle for ‘consumer’, ‘research partner’ and ‘patient advocate’. They say little and contextually mean not very much. That is perhaps a strength.

 

 

Find a fitting tribute …

Tessa Jowell blazed like a comet in cancer advocacy for a few months, and now she has gone. The coverage of her death has been perhaps too much of a mawkish celebration by the political and media glitterati. Monday morning’s Today programme on Radio 4 managed to be toe-curling, with the Secretary of State for Health incongruously struggling to explain adaptive clinical trials and a cringe-making interview with Tessa’s husband and daughter about her last days.

Tessa Jowell was a valued and respected cancer patient advocate, for all too brief a time. She used her position in society in an appropriate and powerful manner to get important messages across. She blazed a fire across the world of research and treatment of brain cancer in a way no-one before has done, with clear and coherent messages and purpose. It is wonderful when one advocate manages to create change; it is rarely as public, and this is my point.

There are hundreds of other cancer patient advocates, working locally, nationally and internationally. Their fire is as hot as Tessa’s but the political and media elite find the subject of cancer too difficult to handle unless it directly affects their charmed circle. These less well-known advocates also reach the end of life, unnoticed except by those close to them, and with no multi-million pound tributes following them. Those of us who knew them respect and remember, and then we get back to facing the challenge of creating change.

These last few days have shown us the nation’s charmed elite in public grief. A £20million boost to research into brain tumours is their tribute (after years of ignoring the issues). How difficult would it be for the government to put a fraction of that into supporting other Tessas, supporting patient involvement in research? If that was accompanied by noticing the achievements of the many patient advocates working day in and day out to make change happen, it might be an appropriate and lasting tribute to Tessa Jowell and the role she fulfilled in the last months of her life.

It might also provide someone who could help the Today programme understand adaptive trials.

In praise of the “consumer”

As a patient involved with cancer research for more than 15 years the semantics of patient involvement are somewhat frustrating.

It all centres around, what are we called?

The UK’s National Cancer Research Institute (NCRI) which paved the way in cancer calls the patients and carers who work on its various study groups “consumers”. That term was decided nearly 20 years ago as a non-specific way of including patients, carers, bereaved and long-term survivors – anyone with an interest in cancer as a lay person. Some “consumers” over the years have had a science background, most have not. So being a lay person with an interest and a preparedness to learn has been the prime qualification. There is now a proper recruitment and training process. The differing abilities of each individual are recognised. Several “consumers” have advised the NHS and major charities at a strategic level, have worked on funding panels handling programmes costing millions, many speak about research at leading conferences, and the Consumer Forum provides a structure for experiences to be shared. The Forum now numbers 90 people, more than half active on NCRI study groups, the remainder having served their time and working in other areas.

The question of whether there is a better word to use than “consumer” has been argued over many times.

The term “Research Partner” is getting wide use. Some of the Clinical Trial Units are using it, the Wales Cancer Research Centre (WCRC) uses it, and it is widely used in the supportive and palliative care community. But adopting “Research Partner” gives problems to some organisations. Partner is a very specific word, with implications, and some people find its use confusing in this context. There are also times when it is valuable to recognise actual patients from those who have a cancer experience in other ways.

The National Institute for Health Research has its Patient Research Ambassadors, but these should be seen as a different side of the involvement and engagement issue. These people support the front-line hospitals and research clinicians, encouraging accrual into studies rather than helping define major clinical studies themselves.

So what term could we use which might gain general approval and adoption?

Should we seek a single term, might it be better to have several terms which help define the actual work undertaken by involved patients?

After all, at the moment the deep involvement which NCRI consumers have in the NCRI Clinical Studies Groups, or the WCRC Research Partners have in their Research Themes, is not replicated in many places. In these areas patients have helped determine the direction a study takes, looking at endpoints, inclusion criteria, use of placebo, stopping rules, crossover – the list is a long one. They have questioned a research programme’s proposed priorities, advised changes which help accrual or serve to reduce patient burden in a study. However, their most important effect has been to change the nature of the conversation, the process has evolved under their influence over time and is now conducted differently from what it was fifteen years ago. Should these involved patients have a term to describe them which differentiates their commitment and growing knowledge from others, who may simply be brought in ad hoc to be consulted at some point in developing a study and to allow the researchers to tick the box on the funder’s application form.

The term “Patient Advocate” is widely used in Europe. This also has problems. Not all patients working in research are advocates and not all advocates are patients, yet the term is used in an all-encompassing way and takes no account of the depth of experience each individual may bring.

The trouble is I don’t have an answer.

At the moment I have so say I wish long life to the term “consumer”. Because only the NCRI and some of its affiliates use the term it is acquiring an aura which reflects the experience and the standing of the members of the Consumer Forum. The word is acquiring a new meaning in cancer research.

This is Part 1 of my thoughts. Part 2 will follow next week.