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

PROs at the centre of cancer care

Chemotherapy or supportive and palliative care? Its a question which oncologists are increasingly addressing with their patients. People with advanced solid tumours, that is cancers which have spread to secondary sites, are very rarely curable, although maintaining stable disease for a significant time is increasingly possible. Symptomatic treatment with the aim of delivering a high quality of life may be preferable to a so-called curative approach.

One of the communication challenges is the widespread belief that chemotherapy in these circumstances will deliver a cure. Oncologists can do their best to help patients to understand the situation but they cannot educate family and friends. Patients often lack the necessary mastery of the information or the skills to convince their family of the reality. Family pressures to undergo chemotherapy can be very real for those who are already vulnerable.

The new targeted therapies do change the picture for some patients. If your tumour carries a genetic or biological target which is treatable extra time can be bought, sometimes with few side effects, although there can be a financial cost and cure remains rare. These drug costs are becoming a significant part of the NHS cancer drugs budget and the struggle to keep costs under control is highlighting the challenge which society faces, to understand the holistic value of these treatments.

Value lies in the underlying reality that secondary solid tumours kill their host. Patients without secondary tumours usually survive their cancer. Treatment with high cost drugs to prevent secondaries is a ‘holy grail’ for pharmaceutical companies, the demand would be very profitable. Their urge for acceptance of their costly new treatments excites the media, which rarely reports the realities.

Today’s realities offer a different picture. Early diagnosis and skilled primary treatment are the surest ways of delivering better survival. The renewed NHS focus on this is welcome. Cure represents value. However, there will always be people who, for whatever reasons, present late and with secondary tumours. Proper supportive care is needed for them and the NHS is not as good at responding to this need as it could be either in primary or secondary care. Attention to value is required.

The value issue principally focuses on those with secondary tumours which develop while in follow-up or care. How does treatment affect a patient’s life, whether that is chemo, new targeted drugs, interventions such as surgery or radiotherapy, or symptomatic care. What is the balance with cost? Health economics looks at ‘cost effectiveness’ but this is more about how a patient clinically responds, and for how long, to any treatment rather than how it affects their life.

Looking to meet the modern demand for an acronym Value can be defined this way (from a patient viewpoint):

Variations in my Actual Life and Usual Experience

Attempts to look more holistically at value to capture actual life and usual experience through the lens of patient reported outcomes (PROs), are still at an early stage. The tools which have been developed so far are clumsy and the challenges of implementing them effectively are still being worked out. There are good people working on this (not enough of them are actual patients) but many research organisations give it a low priority so funding is small and progress slow.

Regulators and legislators need to step into this area. Their work is increasingly relying on good data drawn directly from patients. The oncologist and patient who today are having that difficult conversation about chemo or not need the data too. Patient Reported Outcomes are the future shape of healthcare regulation and practice. They are not a nice add-on which appeals to ethics committees, they are an essential element in the science of treating people with disease. PROs can deliver an understanding of real Value to society. They must be taken seriously.

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.

 

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.

Detecting the otherwise undetectable

The perfect pill is the one which treats the feared but undetectable illness. It leads to sales in the billions as everyone seeks to take it. Day dream profits for a pharmaceutical company, Nobel prize for the scientists behind it, new energy for the global economy … enormous potential … but we are not there yet.

The idea of testing for the otherwise undetectable cancer is here. It is only one step more to get to the day dream. The test delivers genetic mutation information, this must have pharma companies salivating. The now-detected but otherwise undetectable cancer is not treatable by non-medical means unless it is allowed to develop to the point where it is identified and treatable … unless medical therapies are developed. Demand for those pills will be huge. Genetically targeted therapies cost thousands.

Roll on the pill revolution.

Is this blood test, which got so much press coverage over the weekend, really as valuable as reports suggest? Fortunately some level heads from UK academic research were more careful when interviewed. Lets also look at it from a patient viewpoint and ask if it will serve the objective of earlier diagnosis in the way which is being suggested.

Screening was implied. Screening who, is not explained. A screening method must balance its costs against the savings created by earlier detection. This means criteria to refine those screened to the most likely people to show a positive result. Screening also has downsides. It has false negatives (failing to spot someone with cancer) and false positives (indicating cancer when there is none present). It can lead to over treatment and unnecessary long term side effects. And of course it creates anxiety – which would include those who have been diagnosed too early to be effectively treated because no tumours are visible. This will create demand for a pill.

Used in primary care the test would have value if a practitioner suspects cancer. Today such patients are sent for imaging and other tests to gather actual evidence. A blood test may do that quicker and would have particular value where symptoms are vague. It could lead to a quicker and more accurate diagnosis in cases of real uncertainty. But treatment may not necessarily start more quickly … unless a pill is available.

Before introducing the test we would have to be certain that all rare forms of cancer can be covered, maybe not immediately but quite quickly after the test becomes standard practice. Expanding eight cancers to several hundred could prove challenging. Its no use saying to a patient your vague symptoms don’t show you have one of the eight cancers if they are shortly afterwards diagnosed with a rarer cancer. From a patient viewpoint cancer is cancer, the test failed.

So once again I am finding myself appealing for context when clever medical science is discussed. The idea of a blood test providing early recognition of cancer has important implications. If the technique comes through the next stages of research showing a high percentage of accurate diagnoses, covering more cancers, with few (if any) false negatives or positives in early stage otherwise unidentifiable cancer, then we will be able to think about changes in primary care practice. The proper analysis of practical and cost issues, including the cost implications of consequent medical therapy, can then be addressed.

I think this is all a long time away and I have to ask, is a pill the real objective of this research? Society needs better ideas than this one to detect cancer earlier. Don’t day dream too soon.

We Are Stronger in Partnership

This theme is often the sub-text behind a conference combining patients and clinicians on the same agenda, but these are usually patient-led conferences and the theme rarely makes its way into professional events. When it happens it is done very cautiously, patient contributors are usually sought at the last minute, and even though the audience feedback is almost always appreciative the repeat event does not do it any better.

Out with the old and in with the new, that was the approach taken by the Rarer Cancers Europe project when developing a training course for both patients and professionals with ESMO and ESO. It was held in early December in Milan and it was a great success.

An initial plenary session on the Saturday included talks from professionals (Jean-Yves Blay, Paolo Casali, Paolo Dei Tos, Rolf Stahel) and patients (Kathy Oliver from IBTA and Francesco Di Lorenzo of ECPC). Questions came almost equally from patients and professionals in the audience.

Separate professional and patient sessions started after lunch on the Saturday. The patient programme focussed on Advocacy Issues in Rarer Cancers. The Saturday and Sunday sessions covered clinical issues – diagnosis, surgery, oncology and research. Individual clinicians and scientists came from the professional event to talk for 20-30 minutes on a defined topic and to answer questions. These sessions were lively with lots of issues and new ideas put forward by the speakers, and plenty of challenges from the advocate audience to keep them on topic and on their toes.

Meantime the professional session looked at some specific tumour types. Patients from the advocacy group attended sessions of personal interest, often raising questions which some of the professionals attending would have liked to ask but because they did not want to look ill-informed in front of their peers were too nervous to do so.

The advocacy research session was particularly lively when Dr Paolo Bruzzi (a statistician) and Dr Paolo Casali (medical oncologist) came together to talk about probability statistics in a joint session. At one point they put forward a hypothetical trial of intercessory prayer, examined how probability would affect its results, and how it would compare with a study of a more usual medical therapy. The subject of combination therapy was raised, which caught both scientific speakers unprepared. A humorous moment. It was followed by a stimulating talk from Eric Low OBE, a very experienced advocate, looking at the social, cultural, political and medical pressures to change research models and rely more on real world evidence.

The final session on Monday looked at advocacy issues, drawing on the long experience as an advocate which some members of the group had. The presentations included case studies of activities successfully undertaken by patient advocacy groups. These were listened to carefully by a couple of senior clinicians, sitting quietly at the back.

A closing short plenary summarised the weekend. These was agreement that it was a great success. Dr Casali, who led the event, deserves congratulations. The combined audience recognised the value of a parallel conference for clinical specialists and patient advocates which sets out to make maximum use of the skills and experiences of each group for the benefit of the other group. Both the planned and the unplanned interchange of audience members according to personal choice was truly valuable.

I look forward to seeing similar structures evolve in professional events everywhere. Let conference companies take note.

 

Time for Change

In early November I attended the NCRI Conference in Liverpool. I was offered a bursary by NCRI to cover my expenses and as I was speaking in a session on Quality of Life my delegate fee was waived.

It was an event which I enjoyed, as I have every other NCRI Conference since it started in 2005, although I missed a couple because I was having treatment at the time. It is a valuable way of maintaining contact with people across the spectrum of cancer research, scientists, clinicians and patients. Of course that social element is not the main reason for having the event, which includes a large amount of exhibition space. What is noticeable is that large pharma companies do not exhibit and that clinicians are few in number, those attending being ones with a significant research responsibility. Laboratory science dominates and NCRI has little to do with laboratory science. The main conference sessions are a bit formulaic – three ‘levels’ of plenary, symposium and parallel session, the latter with three or four speakers and the content mostly fixed months beforehand – leaving little opportunity to reflect ‘breaking’ news.

The ambition for joining everyone up, which Professor Sir Alex Markham expressed in 2005 (he was then NCRI Chair), has withered and it is a very one-sided event with token recognition of what NCRI actually does. The structures also fail to recognise that NCRI is not the NCRI of fifteen years ago. It is now an independent charity with its charity funder/members working together to develop cancer research at a policy and strategic level, not to fund it, educate its staff or evaluate the science.

One of the stresses is that the NCRI Conference is underwritten by Cancer Research UK, and all credit to them for carrying the venture forward. It is intriguing that as Cancer Research UK has started to bring its weight to bear on policy and strategic issues, very effectively, it has failed to ensure that these issues are represented properly in the NCRI Conference. They are trapped by the rigidity of programming structures which cannot respond to current events. CRUK, also to its credit, is a significant funder of NCRI.

It is becoming clear that things have changed and the Conference is overdue for a re-launch in new colours. It does not reflect NCRI’s activities or the needs of NCRI itself that could be met through having a proper national event to consider policy and its implementation, new initiatives (such as the current Survivorship partnership) and the steps being taken by member charities which could be better if joined up. Change is never easy, or comfortable, but it is needed. Clearly there will be funding issues and a re-launch would need to be carefully positioned.

A critical part of that positioning is the relationship with pharma. While the industry self-regulatory system fails to recognise that patients have a valued role to play in the design and development of research, pharma cannot fully participate in the way that it should. One of NCRI’s core principles is the involvement of ‘consumers’ – patients and carers. It is easy for NCRI to ensure that patients attending its conference are ‘accredited’ research representatives, whether they work with NCRI or with charities such as Cancer Research UK. The failure to recognise this by the pharmaceutical industry is an indictment of its shambolic, legalistic and patronising approach to patient involvement. Until that changes pharma attempts at patient involvement in research can only be tokenistic and trivial.

So there is much that needs change and as patients we can point it out and pressurise for it.

Roger Wilson is a member of the NCRI Consumer Forum and its longest serving consumer/patient. He was an NCRI Board Member 2004-2007 and closely involved with the first three NCRI Conferences. He is also a Member of Cancer Research UK.

Introducing PPI in Research – Purpose, Plan, Impact

Research is not an end in itself. Many researchers and their managers might think it is but involved patients should not be trapped into this mindset.

We are patients involved in research because we believe that we can help change things for the better. We believe that better treatments can be identified by good science. We believe that better care can result from good quality research. We believe that better processes and systems can be created. We cannot do this all by ourselves, we can only do it in partnership with the professionals. They may be managers, nurses, scientists, doctors, educators, inspectors, commissioners, policy makers or politicians. Research gives us the evidence to support change.

As an involved patient you should never lose sight of this important vision, we are in the business of transforming patient care for the better. Research is a means to that end, not an end in itself.

Sadly the myopic draft standards for patient and public involvement being assembled by NIHR do not address this purpose. The view presented is all inward to the research process, nothing abut what research can achieve to support change. NIHR have acknowledged that the standards are draft and will change. A positive step, I hope the next draft will address Purpose.

Involved patients must be asking questions about Purpose, asking why a research project is being undertaken? What are the issues to be faced in extending a successful study into routine clinical practice? Researchers without clinical experience may have limited horizons and no understanding about practicalities. Patients can bring that perspective, after all usually they will have been there. There is a second PPI in our debate – Purpose, Plan, Impact.

Plan brings me to a second point, a practice I would like to see which would encourage researchers to think outside their usual boxes. Every research project should have a plain language lay summary written at the outset, even before the project is approved. It states what the Plan is. It is part of the public face of the project, on its webpage, in any patient information and consent process, and in the final study report. It makes clear what the study will achieve, for patients. As a project progresses the summary would be regularly reviewed and updated so that everyone will know how it is progressing. The lay summary should also include the why and how of implementing positive results. That should be part of the Plan even if that is expressed only as ambition. That will be how Impact is delivered.

A lay summary used in this way would hardly affect research processes but it would change the focus of research quite subtly. The project would always be associated with its ambition, its anticipated Impact. It would have PPI – Purpose, Plan, Impact.

Let us hope that the next iteration of the NIHR Standards will capture some of this quality, will look outwards not inwards, will focus on Purpose, Plan, Impact.

We don’t need PPI Standards like these?

I have worked as a patient involved in research for over 15 years now. I have been involved in clinical/medical research at just about every level possible locally, nationally and internationally. I like to think I have helped things change and the responses I have had from the professionals would seem to confirm that.

It was interesting to find out about the development of a Patient and Public Involvement Standards process being developed by NIHR (the National Institute for Health Research) and INVOLVE, the national organisation for promoting involvement in research. There is an on-line questionnaire and a website. The objective is to provide guidance to organisations setting up a patient involvement process.

In all good faith I downloaded the documents and began to read. Dull, dull, dull. I have completed the on-line survey but there is so much more to be said, so much that was missing.

 It should sparkle with ambition. It doesn’t. In my experience there is always a danger of a standards process becoming pedestrian. This one is mechanistic and will create a bland environment where achieving the minimum standard is the highest ambition. It will open the way for tick-box micro-management of daily involvement activity and no-one will ever address the question “why are we doing this?”.

Patient and public involvement is about transformation. I know this is ambitious and hard to achieve but it can be done and standards, if we have to have them, must aim high.

Patient involvement demands Board level involvement, not disinterested oversight. Senior managers must identity involvement opportunities within their direct remit. If only junior managers are doing it PPI will wither and fail. Senior managers should be asking every day “where can I involve a patient/public member” not “why should I involve…”

How can we attract high achievers as PPI managers? Absolutely critical for the future.

How do we position taking the role of a PPI manager as a ‘must do’ role for future chief executives?

As I know very well involved lay people can be great at finding gaps which surprise the professionals and open them up. Working together transformation becomes possible. You cannot train for this. You have to find the right people and create or manoeuvre the situations where they can do it. These people can be inspired by the opportunity, they won’t be inspired by a tick-box life.

I welcome standards if they help widen involvement opportunities and create structures that enable and encourage beneficial change. This exercise, as it stands at the moment, is about the detail of daily transactions, not about transformation. It will drive patient involvement into the side-lines.

NIHR – please start again.

Consultation web-page

The Standards survey