If you want Patient Involvement there are no compromises

There is a new healthcare industry. Patient involvement became inclusive as ‘patient and public involvement’ (PPI) and is now rapidly becoming ‘public involvement’. In research it is acquiring an energy, a workforce, an academic community all of its own. We have advice from regulatory bodies, published standards, endless guidance and retrospective analyses of experience in small very specific case studies. We have started to see systematic reviews, with inconclusive conclusions. We have a journal of our own. We even have privatisation as an issue. It is however a uniquely British development and I would argue that we have lost sight of what it is really all about.

Let me put my cards on the table. I attended my first research meeting as a cancer patient in 2002. I am a journalist by background with a long management experience. I am curious, analytical, occasionally creative, and sometimes abrasive. In 2005 I co-wrote the patient involvement plans of UKCRN, the first iteration of what has become NIHR CRN. I attended the DoH interview from which the contract was awarded and took the part-time role of Associate Director for Patient Involvement. I had to relinquish that in 2007 when I required further treatment for my cancer which left me disabled.

I have spent a lot of time in the last year with the largest European cancer research organisation, EORTC. The European Organisation for the Research & Treatment of Cancer is not an EU institution although it does get some project funding from EU sources. EORTC is a Belgian charity, founded over 60 years ago, is currently running or in follow-up with about 200 clinical trials, and employs about 200 staff – methodologists, statisticians, doctors and research scientists. It has partnerships across the world, engages hundreds of European clinician/researchers with specific tumour specialisms and has an influential policy voice. EORTC is considering how patient involvement can be brought into its core activities, there is already some involvement in the tumour study groups. Note that this is patient involvement, there is no role for the public.

In 8 of the last 13 years I have been a patient member of faculty for the MCCR Workshop run in Europe. There is a similar workshop in the USA. This Workshop is an intensive six day course for young oncologists from all around the world. They all have an ambition for research in their clinical career. About a quarter of them are working in the NHS. Many of these young doctors have never talked with a patient about their research before – the exceptions being those from the NHS. None of them however wants a non-patient to be involved with the study they develop on the course. They can accept that I may not have experience of the specific tumour type they are proposing to research but they recognise that I bring a viewpoint from an experience they have not had and that I understand issues in a different way although it is one which is relevant to their plans.

This experience is making me focus quite hard on what I think is essential. I want to get away from the plans that large-scale UK organisations seem to have to simplify terminology and create ill-defined systems which drive relevance out of the original intent.

Our intent back in 2005 was patient involvement. There was a lot of discussion about the use of the word ‘patient’. Cancer was using ‘consumer’ (as NCRI still does) because it allowed carers to be included, in mental health the term ‘service user’ allowed inclusion of family/carers to address some of the communications challenges which exist. Whatever the term actually used the binding principle was that of the ‘lived experience’ – although we had not defined that term then.  The objective was to replicate in the wider healthcare research community some of the benefits which the introduction of a structure for patient involvement had achieved in cancer research through NCRN.  That in turn had learned from HIV/AIDS research in the 1990s where the Medical Research Council had opened its doors to patient involvement.

Patient involvement in research has a clear objective, to enable better research, relevant to patients, which can be explained easily to patients, implemented more readily and can realise benefits for patients more quickly. When I joined my first cancer research meeting in 2002 that was the aim and it remains the aim.

So how did the primary need for ‘patient involvement’ become subsumed, its purposes obscured, into a woolly agenda driven out of organisation speak and something ill-defined called ‘inclusion’? I will let others answer that question. Then there is that appalling trio of PPI. Get rid of it.

Lets get back to core principles. You can have as much or as little ‘public involvement’ as you like, just get on and do it and don’t bother me with it. 

We should focus on ‘patient involvement’ and resolving the challenges it faces. The issue of identifying impact should be rejected. No research group assesses its staff on their ‘impact’, the view is more rounded than that.  Involving patients is a cultural issue, it represents change, and such change can only be assessed by looking at the organisational culture in a structured analytical manner.  As far as I am aware only the NCRI has ever done this, and then perhaps not consciously.  Considering the performance of individuals is a different matter and is closely related to the challenges of recruiting, training and supporting patients to be involved. We find it difficult to identify and turn away poor performers. Many organisations, including NCRI, have solved all of this but the indications are that each resolution is specific to each situation. We can do this. It is not easy but it can be done. The will is there among researchers and among patients, if only you can get to them, given all the obstructions that are put in the way.

People with the ‘lived experience’, not the public, will change research for the better. The easy term is ‘patient involvement’ but we have to treat that as a generic, accepting that it needs refining in different situations. Properly implemented involvement of people with the lived experience is what we must be talking about and getting on with. 

Lets not lose sight of this.

Journal publishing – get rid of the pay wall

There is a situation which we, as patients, have been slow to challenge.

If I say that patients agree to enter clinical studies, which take data from patients, and reports on those studies are then published in medical journals after due review processes have taken place, and are then put on sale, I wonder if you see the problem.

If we as patients want to see the study result, review the data etc we have to pay – usually a fee around $30, sometimes more. We don’t buy because we do not have the resources. We cannot get free access because we do not belong to a body which licences access for its members through Athens or Shibboleth. So we are left with the abstract, at best. Fortunately a number of journals are Open Access, allowing anyone full access to published reports. Some also offer Open Access as a paid option but notably the High Impact journals will usually only offer Open Access if the study sponsor pays a substantial fee up front.

Patient advocates and those relying on understanding research are disadvantaged by the publications system. Some authors are generous and subject to keeping quiet about it let us have a copy of their study report. Sometimes we are able to find a print copy, take photos on a mobile phone and thereby have a reference copy, but that is getting silly isn’t it?

I started to wonder what the ethics of all this are. Patients freely enter studies, unpaid. Their data is gathered, analysed and written up under an ethical process. If it is then published and they cannot access it, is that ethical? The actual patients in that study may well get a copy of the report from the study team which might answer the direct question, but patient advocates and representatives who could use these data in their work for the benefit of patients do not have such access. Is that unethical, or just hard b***** luck?

What makes this worse of course is that patients and the public fund a lot of this research, whether through taxation or charitable giving.

We have to recognise that publishers have to earn a living and that there are various business models available to them in practical terms. We can only applaud those who have an Open Access policy.

It has to be better than this. I cannot see an easy route through but I hope someone can grasp this nettle and help patient representatives get better informed and become more effective.

Sarcoma diagnosis – a new challenge emerges  

Conversations at the recent British Sarcoma Group conference in London (an excellent event) brought up a growing problem with a recent change in the guidance for GPs considering potential cancer symptoms. The idea is that when a GP has suspicions about a soft-tissue lump he can order a direct ultra-sound scan.  When I questioned the chair of the NICE Guideline Group during its development I was assured they had considered all outcomes and my concerns were dismissed. As far as I am aware no specific sarcoma expertise was consulted during the development process.

The question which needs answering is whether the new approach is working for the benefit of patients and/or the NHS.

Prior to the change three years ago a GP was advised to make a 2-week referral to a specialist centre if certain clinical symptoms existed.  More patients were actually being diagnosed from non-urgent secondary care referrals or other routes than from the 2-week system. Hence the change, which made direct access to x-rays (for suspected bone sarcomas) and ultra-sound (for soft-tissue tumours) available to GPs so they can diagnose non-malignant tumours or determine uncertainty which requires expertise.

The problems arise because sarcomas are rare, diverse in their histology and can appear in any location on the body – in fact ‘typical’ is not an adjective applicable to sarcoma. The ratio of benign soft tissue tumours to malignant sarcomas is over 100:1. The rarity means ultra-sound imaging technicians have little familiarity with sarcoma although for bone tumours X-rays can be definitive.

We are finding that ultra-sound imaging reports will err on the safe side. Some tumours are clearly benign but if they have any doubt they are likely to say that they cannot be certain.  So what do GPs do with this uncertainty?  Their uncertainty boundary has shifted so they make a 2-week referral to a specialist centre, even for a tumour which under the old guidance would have been recognised as benign.

Thus specialist sarcoma centres are being overwhelmed by urgent referrals for ‘uncertain’ tumours. Diagnostic expertise is now being exercised by nurses operating triage clinics. This allows their consultant colleagues to spend longer with the fewer potentially malignant cases who come through the triage.  The people with sarcoma who would benefit from urgent attention are being hidden in a cloud of benign conditions until a late moment in the process. GPs are allowed to opt out of responsibility for diagnosing the benign condition, hiding behind the ‘uncertain’ ultra-sound. Those with benign conditions suffer a journey to a regional specialist cancer centre only to be told by a nurse that their highly qualified GP must re-consider their case.

Patients are not being respected. The problem is not the principle of the new guidance, but the implementation which has shifted the workload inappropriately. Those picking up the pieces are the specialist centres overloaded with diagnostic work. The new guidance was intended to help them and it is doubtful whether this is leading to earlier diagnosis of malignant tumours either.  The whole approach needs review in the light of the experience the sarcoma centres are reporting and any review must be in collaboration with them, rather than imposed by a committee led from primary care.

Ask the right questions, get the right evidence

This is the second of my two thoughts about pressures being faced by patient advocacy.

There have been a number of recent articles in journals lamenting the failure of patient advocates to respect the principles of evidence-based medicine (EBM). It is a consistent low grumble from the science community, to which a small group are deeply wedded, while a majority probably have some sympathy with the point but also have some sympathy with the stance being taken by patient advocates.

There has been a change in the attitudes of regulators. Not that long ago they too were wedded to the evidence-base and they would maintain that this principle still underpins their decision-making. But in that decision-making, and therefore in the processes and procedures they employ, they are being more pragmatic. That has been partly driven by patient advocacy.

Some voices in the regulatory community are also identifying the issue which I believe needs to be addressed and which EBM protagonists seem to be studiously ignoring.  It is quite a big question.

Are we gathering the right evidence in clinical trials and in the way we measure and report real-world clinical care?

No-one in medical research seems to be addressing this effectively. A few are tinkering around the edge of the issue and for some, the idea that we are not gathering the right evidence, is like voicing heresy.

Cancer clinical trials are focussed on some measure of survival or tumour response to treatment. The so-called ‘gold standard’ measure of Overall Survival becomes difficult when a treatment is one of a succession of different therapies. A wide range of surrogate measures are used as a substitute. These are often dependent on some degree of investigator interpretation so are inherently unreliable, a factor which it is convenient to forget.  Side effects of treatment are an important issue and these are reported too, usually using an investigator applied judgement of severity against the CTCAE standards.

All this is a focus on objective measurement of the disease and the effect the treatment has on the disease. No-one is denying that this is important but where are the measures focussed on the patients themselves and the effect on them, their subjective reporting.

This is what patient advocates have been pursuing with their regulatory campaigns which the EBM stalwarts claim ignore the evidence-base. The advocates have an evidence-base in patient stories and anecdotes, but it is not one which they are in a position to measure, the professionals are not measuring it and have been ignoring it for more than twenty years.  So the EBM complainants, writing stridently about patient advocates not playing their game, would do well to look at themselves and their colleagues.

Are they asking all the right questions: are they gathering all the right evidence?

There is a side issue here about patient involvement. It is an issue which patient involvement cannot easily address and could be used as an excuse for inaction. Untrained involved patients do not necessarily see this ‘right evidence’ issue, they are often overwhelmed with understanding the planned outcomes and endpoints in a study. This assumes, of course, that they are consulted at a timepoint when they can actually input such ideas.

The second side issue is that we have much better ‘big data’ now than we have ever had. The ability to look at clinical practice across years, aggregating the experience of thousands of patients, means that retrospective analysis can provide valuable information and new insights. The question is, are we asking all the right questions in these analyses if the right questions were not asked when the data was being first gathered?

So the challenge for the data analysts is not to turn EBM into a self-justifying paralysis of ideas which ignores the patient?

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.