Tag: NICE

End-of-life care should be an openly discussed topic

End of Life care is not usually regarded as a front page headline topic by the popular press, nor is it a frequent discussion point in cafes, pubs or bars. It is an important topic nonetheless, if only because it is the one area of healthcare which very nearly all of us will experience. Sudden death, from whatever cause, is not the usual way to die.

This lack of debate might be understandable if everyone who died did so in a quiet, caring, and capable environment at home or in hospice. In the right hands the well-evidenced Liverpool Care Pathway (LCP) helped a lot of people cared for by those trained in its use. NICE actually recommended it. However the fact is that hospitals are still the main place where people die and there have been horrific accounts of poor and insensitive care of those dying in hospital.

The abandonment of the Liverpool Care Pathway (LCP) a year ago shows us the nature of that problem. The review into the LCP led by Baroness Julia Neuberger was generally damning of hospital end of life care. A tick-box approach to the LCP de-personalised treatment, they were highly critical of the quality of communications around the dying person, and deeply critical of hospitals’ inability to respond to the needs of families and their loved ones, especially those dying at weekends or in the middle of the night.

“In the wrong hands,” they said, “the Liverpool Care Pathway was an excuse for poor quality care.” They went on “Generic protocols, as the LCP has come to be seen, intended to be applicable for all patients in the last hours or days of their lives, in any setting, are the wrong approach.”

The publication of guidance from the Leadership Alliance for the Care of Dying People followed quickly and set new standards. The Alliance was made up of 21 organisations including the Department of Health, NHS England, NICE, CQC, NIHR and key charities including representation from the Hospice movement. Their guidance is a direct response to the Neuberger review, accepts its recommendations and points to the supporting evidence base to guide local implementation. It confines itself to establishing strategic guiding principles, it does not replace the LCP. No-one following these principles and guidance will reproduce what is bad but they have to make up their own minds about the details of practice and focus that on the individual, not a protocol. The guidance emphasizes the need for individuality of care, giving proper respect to each person and their needs.

The guidance is extensively supported on the NHS Improving Quality website, with direct access to training information, so there is no excuse for any healthcare professional concerned with the care of dying patients not to have referred to it at the very least.

Now NICE is consulting on the draft of new Guidance for care at end of life. This will be authoritative. It is open for comments until the 9th September. At 266 pages its no lightweight and the supporting evidence is a much bigger tome. The group developing the Guidance was chaired by Professor Sam Ahmedzai from Sheffield University, an internationally respected palliative care clinician. If nothing else the list of 67 recommendations is worth reading to take in the breadth and depth involved in creating personalised care at end of life. They also point to four areas of clinical research priority which will hopefully be picked up in the near future.

One issue which affects research is that there is no clinical priority for end of life care research in the NIHR Clinical Research Network. It is a topic which is ignored in the way the Network has been structured. The 30 speciality topics mostly have a disease theme. In all probability the four end-of-life research priorities (and others which arise) will get researched through the cancer theme. The NCRI seems to be alone in clinical research in recognising Palliative Care with its own Clinical Studies Group (chaired by Professor Ahmedzai).

In addition to the clinical issues there is a need to better understand why so many people die in hospital when research shows they wish to die in their own homes. There have been numerous small studies, mostly focussed on one institution. There is no reason to doubt one conclusion that the communications problems and mechanics of transferring uninterrupted active care from a hospital to a GP, who relies on the support of multi-agency resources in the community, are dominant but there is a very real need to find ways of making it better.

There is also a need to find out what are the key measures which can evaluate performance. This may sound a bit callous. Maybe it is one of the characteristics of this topic that there are aspects which feel a bit insensitive. But it does affect all of us and I know that, when it comes to my time, I want to know that I am getting the best care there is.

 

Quality Standard sets new challenges

The publication of the Quality Standard for Sarcoma by NICE open up a new set of dialogues in how to improve the standards of sarcoma care in England and Wales. The NICE standing committee on quality recruited six members of the sarcoma community to advise it and to be part of the decision structure during the development of the standards so, hopefully, they are rooted in the realities of daily provision of care and treatment. The standards can be found at: www.nice.org.uk/guidance/qs78/chapter/list-of-quality-statements

The first standard calls for clear pathways in diagnosis. This is something for the wider NHS to develop, informed and supported by sarcoma MDTs. There was discussion about the value of local diagnostic services and a real example of development work from Yorkshire where DGH ultrasound operators play an important part in the diagnostic pathway. Other areas are also making important steps in improving GP awareness, for example. The hope is that other commissioners and NHS managers will look at how local services can develop, working with their local sarcoma MDT.

The second standard re-affirms the requirement in the NICE IOG that all sarcomas should be treated in consultation with a sarcoma MDT. It does it however in slightly different terms and gives a Sarcoma Advisory Group (the local oversight group in the NHS) the power to determine which treatments for which groups of patients can be managed outside a sarcoma MDT. In the case of children, for example, the decisions will be easy because the current systems work well. In the case of gynaecological sarcomas those in the gynae community who are reluctant to refer their patients (often until it is too late for any benefit to be gained) can be brought into line (we hope).

Statement number three is an important one for the development of the sarcoma treatment network. Sarcoma MDTs must make public their skills and the pathways they observe. Clearly this will be valuable information for patients. It should become obvious that having a multitude of different sarcoma oncologists in different locations all treating a few gynae patients (for example) is not a proper way forward. Every MDT will need to decide what it handles and what it refers on and to whom – very much in the same way that they may diagnose a bone tumour but pass it on to one of the recognized bone centres. I hope we will see development of regional experts in some areas, giving one centre a critical mass on which to develop a specific expertise. This can only help patients in the longer term. It might also be good for some careers. It is important that MDTs recognise their strengths and where they may be weaker and do not try to maintain a “we can do everything” stance. The NHS England Sarcoma CRG will have a role here, alongside SAGs.

The next statement can be linked to the previous one. Retroperitoneal sarcoma patients have their best chance of survival with radical surgery at the first intervention. There is currently a trial underway to see whether radiotherapy may improve that. There have been too many patients treated conservatively, followed by recurrence and decline. Data from international series also show that high volume centres which can develop expertise, offer real benefit. The NICE rules forbade the quality standard from being specific about this but the Quality Statement is an open invitation to professional associations, the NHS England Sarcoma CRG and to commissioners to put in place structures which meet the Quality Standard and improve outcomes.

Statement number five recognises that there may be unplanned resections of sarcomas but once diagnosed patients must be referred for treatment to a sarcoma MDT. Most limb/trunk tumours will be diagnosed and treated by a surgeon who is a core member of an MDT but in other anatonical sites it is not enough for a diagnosis to be made and surgery to go ahead locally. The sarcoma MDT must be brought in to discuss the treatment plan (Statement 2) and for planned surgery in the anatomical specialty the sarcoma MDT must nominate the surgeon as an extended member of the MDT.

The final statement makes it a requirement that there is a nominated key worker for every sarcoma patient. This includes patients whose care and treatment is co-ordinated through a site MDT (such as Upper GI or Gynae). It makes it an imperative that in agreeing that a site MDT can look after a patient this statement is observed by the site MDT. There is also the implication that a single person in a sarcoma MDT is not adequate for this role. Illness, holidays, training all take people away from their duties and it is essential that patients do not lose this kind of contact. So trained cover is a minimum requirement.

At first sight these standards look quite gentle. Close examination shows that there are some big nitty-gritty issues hidden in them, as I am sure you can see, and it will be something of a challenge to attitudes and behaviour to make this work. The sarcoma network in England has been slowly coming together and with the BSG now properly constituted and ready to take some actions and decisions, together with a Sarcoma CRG which is clinically led and has a role with commissioners, we have a structure which could initiate action and deliver new benefit to patients.

Update – a view from the sunshine

The idea of getting away for the worst of the winter has always been very attractive. This year, for the very first time, we have been able to do it and we have gone to the Costa Blanca. The weather here is like an early summer’s day at home. Temperature out of the wind is in the mid-20s, though the wind has a chill to it and the official shade temperature comes down to 17 degrees. Its hard not to gloat, knowing the UK is in the grip of snow and ice with temperatures below zero for most of the day.

Going away however has other dangers. Everything seems to be happening. The Cancer Drugs Fund debacle, Harpal Kumar’s Task Force, at Sarcoma UK we are about to publish our study into gynae sarcoma, and NICE is about to publish (later this week) the Quality Standard for Sarcoma – the first of the rare cancers to have a Quality Standard. We also have the British Sarcoma Group Conference at the end of February. And then there is a General Election in May – although with the intensity of the campaigning which is already underway you’d think it was in early March.

So where do we stand on all these happenings?

Two weeks on from its controversial announcement CDF is revealed as a tawdry beast, built by politicians then deserted by them, taken on by a strong oncology commitment with patient interests at heart, unsupported by mandarins and then dumped by them when the heat built up. CDF will have spent over £1.2bn by the time it is meant to finish in 2016 and it has not gathered a single bit of efficacy data to support its spend. It has distorted the research community as new indications have been funded immediately off-label rather than real evidence being developed in an academic trial – a letter from Professor Matt Seymour of NIHR to Sean Brady, National Clinical Director for Cancer revealed that issue. Above all it is quite clear that the pharmaceutical industry has been benefitting, some companies being exploitative in their approach to it. The one thing it has achieved is to get people thinking evidence, research, new methods in research, and rational approaches to drug regulation.

Harpal Kumar’s Task Force is a welcome development. Not only is he the right person to be undertaking such a sweeping review it is going to be done quickly. The aim is clearly to have something approaching a new Natonal Cancer Plan by the time there is a new government. The new emphasis on early diagnosis will clearly be a key part of whatever comes out of the discussions.

Sarcoma UK”s report on gynae sarcomas deserves close attention. it is sub-titled ‘The Hidden Cancer’. We have long believed these patients are among the worst treated in the whole cancer community and this survey, of over 50 patients, shows just how poorly treated some of them are. There will be attempts to deride this study as too small to be representative. Consider however the sample size and the incidence of the disease. It is equivalent to an 8500 patient study in lung cancer – that would never be ignored, it would get front page treatment. Available on Sarcoma UK’s website from Tuesday.

The NICE Quality Standards programme is something of a treadmill for those involved in it. The process for a standard in sarcoma started in spring 2014, finished before Christmas and is being published at the end of January. The aim is a set of clear statements which define a quality service in the NHS and together with defined measures allow commissioners to assess quickly whether they are getting value for money. The NICE standing committee was supplemented by six people with an interest – two surgeons, an oncologist, a radiologist, a specialist nurse and a patient (me). There was lots of detailed debate, including some passionate episodes from a member or two. We agreed that diagnosis and the pathway to first treatment were the priority so when you read them (published on Friday 29th) do not be put off by the tight focus on the early stages of disease. More on this in due course.

The BSG Conference is from February 25th at the East Midlands Conference Centre in Nottingham. It is the annual educational event of the UK sarcoma community and provides the best all round view of developments from treatment, nursing care, through NHS structure, to regulation and of course sarcoma community affairs. If you are interested see the BSG wesbite at www.britishsarcomagroup.org.uk

As for the General Election – I leave that to others.

Cancer Drugs Fund – inevitable signal for wider change

If I remember correctly the Cancer Drugs Fund was set up at the same time as the Government announced it was to establish a value-added base to NICE drug appraisal which could support and reward innovation. NICE was left to consult on it, which it diligently did. However it became apparent that without an agreed definition of ‘value’ and without agreed means and methods of measuring and quantifying ‘value’ this was a fruitless task. The current Secretary of State has made no comment on this issue and his dis-interest in value/pricing has left the Cancer Drugs Fund exposed in an unsustainable way that means that the Government just has to keep putting more money in.

The re-working of the Cancer Drugs Fund, now underway, is long overdue. Professor Peter Clark, the well respected oncologist who chairs it, has been left with the difficult task. One can argue that he has been left with the problem when the politicians who created the fund, and NHS England, which now owns it, don’t want that profile. Sadly for him, I don’t know of anyone better equipped for the task. He is, however, going to field a lot of criticism and it is going to echo into the l;eval system and the political arena.

The Fund was set up to ensure that people with a rarer cancer got an equal chance at new technology drugs as those with more common cancers. It was also aimed at treatment which had been refused NICE approval. Among rare cancers are drugs which have applicability to 50 or 60 patients a year and which are never going to be appraised by NICE because the cost of doing so is unreasonable. These should get funded. At the other end of the scale it is questionable whether a drug which NICE has rejected on the grounds of cost effectiveness should receive funding. However such drugs quite often already have an applicability outside the strict indication for which they were appraised by NICE. It is a factor of timing as much as anything else and these new indications can carry a badge of rarity because they are off the standard track of treatment.

The CDF budget has inevitably burgeoned and the focus on drugs is also threatening to distort the evolving balance of treatment opportunity as new technologies in radiotherapy and new therapy methods employing techniques such as sound and light, appear.

The review was inevitable, the squeaks of complaint from pharmaceutical companies are inevitable and the protest of patient groups is inevitable.

What is the answer?

There is no easy answer but if we look at the longer term history, which provides the context for the CDF, we can perhaps see a way through. The answer is in NICE which has consistently failed to recognise cancer as anything different from other disease/treatments areas. It uses a generic means of assessing the quality of benefit achieved by a treatment in isolation from the whole patient context in which that treatment takes place. Its former chairman, Professor Sir Michael Rawlins, instructed committee chairs to be ready to use their judgement. However the whole NICE appraisal process is quite rigorously focussed on the new drug and its immediate treatment purpose, not the value a drug can offer in the widest patient sense. The cost per QALY* benchmark has not altered in 18 years, not even to reflect inflation, and bandages put over the process such as “end of life” criteria are just that, bandages.

Peter Clark and his team are not trying to be another NICE but they are trying to identify criteria which allow them, openly, to refuse funding for a drug which offers little or no value. Let us hope they don’t try to evaluate drugs for rare cancers with the same sriteria as those for common cancers.

Rather than wingeing the pharmaceutical industry should be taking steps to illustrate indisputable value in their new agents. The current clinical trials model which industry (and to be fair regulators too) are wedded to does not do that. It’s a broken system. The patient community is not short of ideas on how to change things. The medical oncology community is also beginning to question the endless ‘me too’ drugs, treating yet another tumour pathway and offering another month of life with yet more side effects but only in common cancers of course**. Schemes like Cancer Research UK’s Stratified Medicine programme are welcome developments which will help change the shape of treatment and of drug regulation. Bring ‘em on.

 

*Quality Adjusted Life Year – a statistically derived measure of patient benefit built on factors which are so opaque you need a degree in Health Economics to argue them.

**Because that’s where you get the quickest payback.