Tag Archives: patients

Risks and benefits – what do we patients have a right to know?

Roger Wilson, a patient advocate and Honorary President of Sarcoma Patients Euronet

Roger Wilson, a patient advocate and Honorary President of Sarcoma Patients Euronet

The principle of informed consent is supposed to safeguard our rights as patients to accept or reject a proposed medical treatment on the basis of an understanding about the risks and benefits it offers.

There are big variations, however, in how it is put into practice, which may impact on the decisions patients take regarding, for instance, when to stop chemotherapy.

Last year, a Supreme Court judgement in a medical negligence case (Montgomery v Lanarkshire Health Board) updated what informed consent means in the UK, effectively bringing it more into line with the principle of shared decision making, by giving legal weight to the patient’s concerns and priorities.

Doctors must now ensure that patients are aware of any “material risks” involved in a proposed treatment, and of reasonable alternatives, with the legal test of what constitutes a material risk being decided by “whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk… or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.”

The Court spelt out that the duty to assess whether a patient would regard certain information as significant requires doctors to engage in a dialogue with their patients, and that it is not up to the doctor to make assumptions about how a patient would rate the significance of any given risk, no matter how small.

Information on quality of life

What does this mean in practice for cancer patients? Taking the example of decisions on taking chemotherapy, whether the intent is curative or palliative, doctors offering this treatment must be able to provide information about the impact on quality of life and prognosis.

A risk to quality of life can be as significant to a patient as any medical risk.  But while doctors have always been required to make information on medical risk explicit in the consultation, information about how patients experience impact on quality of life, presented in lay language, is often missing.

In the light of the Temel study of palliative care in patients with incurable non-small-cell lung cancer – which found that patients offered palliative care soon after their diagnosis tended to have less chemotherapy and yet lived longer – a failure by the profession to address this information gap could be regarded as some kind of professional conspiracy.

Information on prognosis

A recent Dutch study into making decisions about chemotherapy treatment indicates that doctors need also to be much clearer in informing patients about the extent of benefit they can expect. The study asked patients (including patients with terminal prognoses) about the levels of benefit (chance of cure, additional months, symptom relief) they would require to accept mild or intensive chemotherapy regimens. The responses, on average, indicated they would expect high levels of benefits  “beyond what is realistically achievable”.

Following completion of the questionnaire, all the cancer patients in the study went on to receive chemotherapy, despite the likelihood of benefit being in most cases below their stated minimum threshold, suggesting the majority entered treatment with unrealistic expectations, which raises questions about what information they were given and how.

The study went on to explore the reasons for the lack of realism among patients. It raised concerns about the quality of communication between patients and doctors, and it pointed to an earlier Dutch study which looked at collusion in doctor-patient communication about imminent death, and indicated that social attitudes such as “not giving up” reinforce unrealistic expectations and thus acceptance of toxic therapy.

A study of English data published in August offers an interesting addition to our insight on the overuse of toxic therapies in patients who do not stand to benefit. It looked at the use of Systemic Anti-Cancer Therapy (chemotherapy) in breast and non-small-cell lung cancer patients in England in 2014. The patients were divided into two groups, those treated with curative intent and those for whom the treatment was “palliative”, ie it could delay not cure the cancer. They analysed the outcomes for a total of 23,228 patients with breast cancer and 9,634 patients with non-small cell lung cancer in the two groups, and how many of these patients died within 30 days of their last chemotherapy treatment.

In the palliative care group 1289 (8.4%) died within 30 days, while in the curative group 0.3% of the breast cancer patients and 2.7% of the NSCLC patients died within 30 days. There is no evidence that the deaths are clustered, so it is reasonable to assume that practice standards are similar among all the providers although the authors highlighted a small group of outliers.

Patient reported outcomes measures

Where does this leave our rights to accurate information by which to decide on whether or not to accept chemotherapy, particularly in a palliative setting?

I think we need a rapid and comprehensive adoption of patient reported outcome measurements in oncology care, aimed at providing reliable evidence-based descriptions of the impact of systemic treatment on life quality and on the prognostic pathway.

Where is the research on what cancer patients see as significant risk? None of the existing quality-of-life tools are adequate – apart from anything else they measure a researcher’s view of the criteria that matter, not a patient view.

Only through patient-reported outcomes data, effectively communicated, can we reduce the number of patients having their last days affected by toxicity. Using patient reported data could also help doctors break the “collusion” reported in the study from the Netherlands. And in countries like the UK, where patients’ rights to information they consider significant is now enshrined in law, we might also avoid a situation where doctors could be taken to court.

 

 

Empower people with cancer by talking about dying

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By Tony Bonser

“There’s nothing more we can do for you. Go home and get palliative care.” That’s probably not the best way to tell someone that the treatment isn’t working, but that’s how one consultant chose to inform our son, Neil, aged 35, that he wasn’t advocating any more chemotherapy for his sarcoma. Not only was it untrue – treatment could have done a great deal to improve his quality of life, but it also assumed Neil understood the term “palliative”. This led to him refusing to seek help which would have led to much better pain management.

Nobody told us that our son was dying – not explicitly anyway. We didn’t hear the truth behind the euphemisms because we were in denial. But when he was in hospital and a nurse asked him what he wanted, his reply, that Neil wanted to go home, enabled him to die where he wanted, in his own flat, with his family and his prized vinyls and books around him. Our last memory is of a good death. That is immeasurably important to us.

Family---Sam's-Graduation

Neil Bonser (left) pictured with his family at his sister’s graduation.

Neil was given the chance to say what he wanted very near the end of his life. When is the right time? Whenever the person is ready to discuss it. I really hope we can encourage a society where such conversations are seen as natural and healthy.

If they have such conversations, doctors will sometimes find that the right thing to do is nothing. My wife Dorothy used to take Tess, a woman with terminal cancer, to day-care. Tess had a wonderful relationship with her consultant, so when he told her the cancer was spreading and offered her surgery, she knew him well enough to see that he thought she might not survive it. He also suggested another option: a change in medication. “It won’t prolong your life,” he told her, “but it might improve the quality of it. It’s your choice.”

She chose the medication and lived to enjoy a two-week visit from her son from New Zealand, going shopping and taking him for meals at her favourite restaurant.

Another acquaintance with terminal cancer was very relieved when I suggested that he had the right to refuse another course of chemotherapy which his consultant recommended. The horrendous side-effects disappeared and he was able to enjoy most of his last few months.

Sometimes treatment will be a good option in the later stages of cancer, sometimes it will not. For me, the issue is about empowerment. It’s about more than persuading professionals to be patient-centred. It’s about professionals giving patients and family/carers the knowledge to make their own decisions and the power to involve themselves in meaningful discussions. It’s accepting that a good death can be a success. Such empowerment leads not only to a better death, but to good memories, which can help the path through bereavement enormously.

Tony Bonser’s son Neil died in 2009. Since then Tony has become a writer and speaker on end of life issues, a trustee of the National Council for Palliative Care and a local champion for the Dying Matters coalition in the UK.

 

All for one, and one for all! Patient power at ESMO 16

Irish melanoma patient advocate, Kay Curtin, blogs about what she took away from ESMO 16.

Irish melanoma patient advocate, Kay Curtin, blogs about what she took away from ESMO 16.

I had no preconceived idea of what ESMO 16 would be like, I applied with an open mind. How would it differ to other conferences in terms of the patient advocacy track would be the litmus test for me as a patient but also an advocate.

The Patient Track at ESMO made it feel I had a right to attend the conference – funny considering I am the one with the disease, the whole conference was based on!! But it has felt that way in the past, like you are being allowed to watch – this was different. This was not just for the medics, what we as a group had to say was just as important and relevant as anything that was revealed at the scientific presentation sessions. The topics covered were wide ranging and engaging, they ran not in parallel with the scientific sessions, but were given proper respect within the running order and it showed.

There was overflow needed for most Patient Track sessions, and those that were attending to listen were not just Patient Advocates, but the Oncologists, the Researchers, and the Pharma representatives. That’s because what we have to say is important and well informed – this is not our job it is our lives, so what could be more important to us?

Often the general public don’t understand the complexities of difference in cancer until you get one. It’s not a topic one reads up on for fun, most only keep up if they are personally connected. Also, all cancers are not created equal – it can become all too apparent that maybe you didn’t get the one with the most support or media air time or the most funding attached to researching it. But at the ESMO patient’s track this year I didn’t feel any of that. I felt instead part of a movement, a revolution of sorts that brought us all together bound by the one thing we have in common: a deep rooted desire to achieve the best for patients no matter what type of cancer they have. We are all in the same boat, there was no paddling your own canoe at ESMO.

“I felt part of a movement – a revolution of sorts”

Did I learn anything from my experience? YES. I am more confident in my connection now to Europe in my approach to my advocacy: I can reach out to many different branches of cancer communities, and advocacy support networks across the continent, and get help and information that’s still relevant to my community. We can help influence change that benefits patients wherever they live. Together, in solidarity we can achieve much more, we can work for equality of access and support for all, regardless of our cancer type or geographical location, we don’t leave anyone behind it’s a sort of unwritten rule, we go back to pick them up and carry them with us, all for one and one for all.

Kay Curtin also blogs at https://irishmelanomapatients.wordpress.com/

Targeting and Trust: QoL in clinical research

Roger Wilson, a patient advocate and Honorary President of Sarcoma Patients Euronet

Roger Wilson, a patient advocate and Honorary President of Sarcoma Patients Euronet

I took a random selection of 20 abstracts from ASCO 2016. None of them mentioned that quality of life had been researched in the study but looking up the detail held in clinicaltrials.gov it turns out that 16 of them did have a quality of life component in them. Whether that will be reported when the study is published is a different question. Experience suggests that it will be mentioned, but that for the most part the detailed QoL data will go unreported.

These are the days of ‘big data’ in healthcare. Increasingly we are seeing databases linked, common standards being adopted to allow similar fields to be aggregated, and increasingly comparisons can be made between key outcomes. The International Cancer Benchmarking Partnership is providing fascinating comparisons on survival outcomes from several different administrations – and it is getting into the detail of differences in the ways that national data is gathered.

The first QoL in cancer study appears to have been in the 1970s. The first paper I could find which looked at developing a methodology dates from the 1980s. We now have a proliferation of methodologies dominated by the EuroQoL EQ-5D which gives the kind of generic background view needed for health technology agencies (HTA) to assess the value of the treatment. Other methodologies relate solely to the study to which they are being applied. Unfortunately for cancer patients, the EQ-5D is too crude report the kind of detail that cancer patients need to know to make informed choices about treatment. For that reason too it can only ever be part of the picture for HTA appraisals.

What do cancer patients need from quality of life information? The full picture of the impact of a proposed treatment in the context of the treatment pathway being followed. We want side effects information, how side effects are treated, and want to know how patients feel when taking the treatment in their own words, not those of some detached academic. We want to know about long-term side effects and what comes after if this treatment fails.

The pathway is the key issue in terms of quality of life – it is not a moment in time, it is life. However there are no data covering the succession of treatments, assessing the interactions that can arise as side effects aggregate, and the challenge of describing treatment and quality of life as end-of-life approaches is avoided.

I looked around to see whether anyone is aggregating quality of life data in a way which could provide this picture. No-one. Why not, after all there is at least 30 years’ worth of data around? The quick answer is the usual big data problem, different methodologies, data fields do not match, each study looks at the treatment being tested not at the patient. The pathway is ignored.

“No-one is aggregating quality of life data in a way which could provide this picture”

We are entering the world of targeted therapies. Targeting is a challenge for randomised studies: they can be unethical, either randomising patients when there is good evidence to indicate one arm is more effective than another, or using cross-overs, which invalidate the randomisation. Phase 2 studies usually do not include quality of life because there is no control group baseline with which to compare the treated patient. A strong response rate (60%+) is enough to ensure entry into clinical practice. One result is that patients are offered new treatments without being able to see a full picture of the step they are taking. Possibly just as important, health technology agencies are denied the whole picture of value which they need to make decisions.

Let us leave aside any questions about whether patients will accept such treatments – these issues disappear when survival itself is your primary challenge. Yet, as trials for targeted treatments reach statistical significance faster and with fewer patients than trials for traditional drugs, patients face increasing uncertainty about the impact of therapies they are taking. We need something to mitigate that uncertainty.

A first step would be aggregating existing QoL data to derive a picture of each cancer pathway, modified as clinical standards evolve. It would provide a baseline for comparing new treatments.

A second step would be using one tool/methodology for all QoL in cancer research. Agreeing that step when there are so many competing methodologies is likely to be difficult.

The third step would be requiring a relevant patient group to be the determinant of the measures to be adopted in each QoL study, small or large. Not easy to arrange but do-able.

A fourth step would be mandating full analysis and reporting of QoL data when it is undertaken in a clinical study. That should not be impossible.

If the cancer research community does not take on this challenge we could affect one of the binding factors of cancer care, trust between patient and doctor. Targeted therapy is an amazing development but we are journeying together into an unknown future built on that trust alone, something we haven’t done for more than thirty years.

We welcome contributions to this blog. If you have a topic you would like to write about, please send your post to Corinne Hall – chall@eso.net You can find our guidelines here – How to write a blog

 

 

Publishing all trial results: a covenant with patients

roger Wilson

Guest blogger – Roger Wilson, Honorary President of Sarcoma Patients Euronet

A recent study from the USA published in BMJ highlights an issue which has been lurking under the carpet, despite the work of the All Trials campaign.

The study looked at the publication record of academically led clinical trials in the USA. It was led by Yale University. More than 5000 trials were identified as starting between October 2007 and September 2010. A number of these were excluded, leaving 4347 across 51 academic institutions to be analysed. Overall 2892 (66.5%) had been published by July 2014. The study has a comprehensive analysis by type of trial and intervention, institution etc and certainly satisfied me it had considered all the issues. It came to the sad conclusion that publication rates are very variable and there is “poor performance across leading academic medical centers in the dissemination of clinical trial results.”

The focus for All Trials has been on industry studies and great steps have been achieved. However this BMJ study shows that the academic world needs closer examination and needs to be provoked into action too. In Europe it may be less of a problem but we don’t know, we certainly cannot be sure. We have clear commitments about publishing from the European Organisation for Research and Trials on Cancer (EORTC) and from many leading academic collaborative groups, national and multi-national. Individual institutions have made commitments too but what is the real story? We don’t know. Is the positive action from the prominent few allowing others to hide away, ignoring the issue in the hope it will go away?

We don’t actually need a study like the one from the USA. We could just start to take action.

The best way of finding out would be through the registration authorities. Each sponsor should provide a simple table of studies sponsored, completion information and planned publication dates, regularly updated and made publicly available. This table could be entitled The Patient Covenant.  Any sponsor (quite often these are academic bodies) which has outstanding trial publications should be unable to register any new trial until their obligations are met.

In addition any principal investigator taking a study to ethics for approval should have his study placed on hold if trial publications are outstanding. This would give a two-tier coverage and will stop institutions breaching their covenant with patients.

“As patients we should be quite uncompromising about trial publication”

As patients we should be quite uncompromising about trial publication. There are no excuses for not publishing. Failure to do so violates the explicit promise made to patients entering the trial that it aims to provide clinical evidence, even failure to achieve a trial objective can still provide evidence. Not publishing impairs understanding and threatens the integrity of clinical evidence, squandering resources in doing so.

I was very taken by four verbs used in the conclusion of the study published by BMJ. Think about them. I use them above and I list them out of context below because I think it adds to their impact:

  • impairs
  • violates
  • squanders
  • threatens

If you are reading this you know the context; avoid these blistering criticisms.

We welcome contributions to this blog. If you have a topic you would like to write about, please send your post to Corinne Hall – chall@eso.net You can find our guidelines here – How to write a blog

ABC steps up to fill the gaps in metastatic breast cancer care

Marc Beishon

Marc Beishon

 

The third Advanced Breast Cancer consensus conference – ABC3 – took place last month at its regular Lisbon home. ABC is the world’s only international consensus meeting devoted to the care and treatment of women and men with locally advanced and metastatic breast cancer. At each ABC conference, a large panel of experts adds and refines guideline statements for managing patients, with the aim of promoting them around the world for all countries, including those that lack the resources of developed nations.

ABC has contributed greatly to a fundamental change in thinking about metastatic disease. No longer do oncologists raise doubts about the feasibility of guidelines for treating such patients – the argument that there are too many variables among individuals is not often heard now.

And the conference has done much to unite the various parties in the advanced breast cancer community – in particular, patients and advocates participate on an equal basis with physicians (including on the consensus panel) and there is also a wide spectrum of professional expertise, again on the panel and in the conference sessions. Psycho-oncology, supportive and palliative care, health economics and survivorship all had prominent positions alongside scientific progress, and a complementary stream for advocates also allowed networking among patient representatives from many countries.

It’s not easy to break down barriers, particularly between doctors and patients, and ABC co-chair, Fatima Cardoso, reminded delegates that the conference has a mission for all to be respectful of the views of others. She also introduced the first results from a major new study sponsored by Pfizer and supported by the European School of Oncology, entitled ‘Global status of advanced/metastatic breast cancer: 2005-2015 decade report’, in which patient care perspective and public understanding have been surveyed across as many as 34 countries, and which also reports on scientific progress (disclosure – I am on the steering committee for the report).

Big gaps remain in areas such as patient communication, involvement in decision-making, and public awareness, where many people still think metastatic breast cancer can be cured, and some prefer women not to talk about it. Dian ‘CJ’ Corneliussen-James, of US group METAvivor, told the audience that prejudice is still a major problem, and that metastatic patients can be made to feel unwelcome by some advocacy groups. There are indications that overall, quality of life may not have seen much improvement.

Dian ‘CJ’ Corneliussen-James spoke about prejudice still affecting metastic breast cancer patients

Dian ‘CJ’ Corneliussen-James spoke about prejudice still affecting metastatic breast cancer patients

In the final session at ABC3, the consensus panel voted on new and changed statements in the guidelines, which will be published next year. There was heated discussion about some while others sailed through.

Briefly, there are important new statements concerning the use of objective benefit scales to assess drugs (e.g. from ESMO and ASCO), which may help to control costs, and on the need to design clinical trials that answer practical questions such as the sequence of using agents.

There are also new statements on survivorship, which is becoming more important as the number of women living with advanced disease for longer rises, and on several supportive care issues.

The consensus panel vote on new and changed statements in the guidelines

The consensus panel vote on new and changed statements in the guidelines

There has only been one new drug approved for the metastatic setting since ABC2, palbociclib, but new data on other drugs such as pertuzumab have changed some statements. The point was made in the conference that innovation in advanced breast cancer is now lagging other tumour types, such as lung cancer and melanoma.

Overall, the conference was notable for the continued integration of patients and those supporting patients into the programme. A highlight was Anna Craig, a young mother from the US, and her video, I am Anna, which was screened for delegates.

See @ESOncology and #ABCLisbon for tweets.

It’s not a war on cancer that we need, it’s a revolution

anna portrait  pic

Anna Wagstaff

The influential Economist magazine describes its mission as “to take part in a severe contest between intelligence, which presses forward, and an unworthy, timid ignorance obstructing our progress”.

So when it turned its attention to organising a conference on the “War on Cancer”, I registered for a press pass. I was familiar with most of the speakers, and I wasn’t expecting to hear anything I didn’t already know. But I thought The Economist might attract an interesting and diverse audience, and I was interested to hear how the discussion would go.

It did turn out to be interesting – but not in a good way. While the agenda was wide-ranging and the chair asked sensible questions to dig deeper into the issues, the audience was largely inanimate – except when the topic touched on new medical therapies.

When it came to the intricacies of the adaptive pathways approach to approving new drugs, the challenge of speeding progress through health technology assessment, the obstacles to trialling combinations of drugs in patients who stood to benefit most, the questions came thick and fast.

When the subject was how to provide care for escalating numbers of survivors, fix unacceptable variations in care quality, provide better access to different types of radiotherapy, or address missed prevention opportunities – silence.

Thinking about it, I should have expected this.

Yes, it was a well-balanced agenda, but the so-called war on cancer in reality lacks any such balance, and it is not surprising that this was reflected in the composition and interests of the audience.

Researching and developing new medical treatments remains the biggest hope for increasing cancer survival, and this effort deserves all the support it can get. But the extent to which this agenda dominates the ‘war’ strategy is out of all proportion to the contribution it is making to reducing death and suffering from cancer.

This point was made in different ways by many of the speakers.  Chris Wild, head of IARC, and Cary Adams, head of the UICC, talked about the central role of prevention, saying “We cannot treat our way out of cancer,” and “Only 3% of the cancer research budget goes towards prevention, and it’s wrong.”

Cai Grau, leader of ESTRO’s HERO project, talked about the role of radiotherapy, which accounts for around 40% of cancer cures, and has been shown to be a cost-effective treatment. He pointed out the benefit to patient outcomes that could be achieved by putting more effort into addressing the severe undercapacity in many European countries.

Francesco de Lorenzo, President of the European Cancer Patient Coalition, talked about the priority patients give to ending the treatment lottery. They want more attention paid to ensuring that wherever they are treated, they can trust their medical team to deliver high quality care.

Jane Maher, Macmillan’s Chief Medical Officer, spoke convincingly about what can and must to be done to ensure that growing numbers of cancer survivors get the support and care they need not just to survive, but to get their lives back on track and lead a fulfilling life.

What they were all saying was that we do in fact know how to make faster progress against cancer, we’re just not doing it. Sadly, this audience didn’t seem to see it as their problem. And this got me wondering about the war against cancer. Is the problem really one of “intelligence versus ignorance” as The Economist frames it, or is it that the people in the driving seat are so focused on their own agenda that the wider interests of the public, patients and survivors are being sidelined?

The problem may be that we are trying to fight a war when what we really need is a revolution.

 

 

 

Stand up doctors: you are patients too

Simon Crompton

Simon Crompton

I count myself very lucky that, as a Cancer World journalist, I get to meet some of the top names in cancer treatment and research across Europe. There have been some fascinating recurring themes from my interviewees over the years: a seven-day-a-week commitment to work; the lasting influence of fellowships to the United States early in their careers; their faith in the younger generation of doctors and their ability to inspire their elders.

But there is one thing that none of these inspiring people ever say, and it has always puzzled me. While most will talk about the doctor-patient relationship and the fundamental importance of patient-centred care, none talk about themselves as patients.

Yes, it’s true that when I ask doctors or nurses about their own experience of cancer they will often tell me about personal or family episodes of illness. But for all our plentiful discussions about the importance of empathy and the intensity of the illness experience, health professionals still talk about “patients” as if they were a different category of person from a doctor or a nurse.

An ingrained them-and-us attitude

When entering into a conversation about, say, patient-driven research, I keep on half-expecting an interviewee to voluntarily say “Well, of course, I’m a patient too” and to talk about how their own experience has helped inform their approach. But they never do: even though 99% of those researching or treating cancer will themselves have consulted a doctor about some ailment at some stage of their lives.

Long-established patterns of working, traditional hierarchies, medical training and a perceived need for cool detachment seem to have ingrained the them-and-us attitude into health and professional systems. It almost seems as if many health professionals don’t dare associate themselves with those on the receiving end of things: they see it as necessary to be aloof, separate from the experience of illness.

Detachment clearly has its place. But it does seem odd that even enlightened health professionals seem to fear there is something unprofessional about openly consulting with feelings about what it’s actually like to be ill, worried and confused.

An odd Spartacus fantasy

Perhaps I’m wrong. It’s certainly true that some doctors have spoken very eloquently about how illness has made them reconsider their work. Oncologist Fazlur Rahman wrote brilliantly in The Oncologist (reprinted in Cancer World in March) about his experiences after a traumatic ankle injury, and how unfeeling doctors transformed his attitude to empathy in medicine. And before his death at the age of 37 in March, neurosurgeon Paul Kalanithi blogged wonderfully about how he handled waiting to die following a diagnosis of metastatic lung cancer.

But it seems odd to me that associating with the patient side often comes as a revelation. I suppose what I’ve been expecting all these years is a more everyday acknowledgement that, actually, the dividing line between health professionals and patients is an artificial one. I have an odd fantasy of a plenary session at an ECCO conference where, one after another, doctors stand up in the auditorium and declare, Spartacus-like, “I am a patient”.