Tag Archives: information

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.

 

 

More pieces in the prostate puzzle

Simon Crompton

Simon Crompton

When are the costs of surgery too great? It’s long been a burning question in prostate cancer, and papers presented over the past few days at the European Association of Urology’s conference in Madrid have added a few more pieces to the risk versus benefits jigsaw.

Speaking recently to Per-Anders Abrahamsson, the association’s Secretary General, for an article to be published in Cancer World, I was told about the current gaping holes in research in prostate cancer. For example, there is no randomised trial comparing radiation therapy with surgery – which constantly gets in the way of good clinical decision-making.

Clinicians and patients are also short of information to weigh about the long-term side effects of treatments – and research presented at EAU showed that the evidence that clinicians currently act on might also be misleading. Take the incidence of erectile dysfunction following prostate removal surgery. The standard way of measuring erectile dysfunction is by the International Index of Erectile Function (IIEF), but researchers from the Herlev Hospital in Copenhagen realised that this might not take into account the sudden change in erectile dysfunction brought about by prostate surgery.

So they added another simple question to the survey: “Is your erectile function as good as before the surgery? (yes/no)”

The difference it made to responses from prostate surgery patients was striking. Responding to the IIEF survey without the additional question, nearly 24% of patients registered no decline in their erectile function after surgery. But when they were asked the additional question, just 7% said their erections were as good as before surgery.

That’s quite a difference for quite a lot of people. Such evidence could have a major influence on decisions about whether or not to have a radical prostatectomy.

Also presented at the conference was evidence about another kind of cost associated with prostate surgery: urinary incontinence. A team of doctors from the University of Nijmegen, the Netherlands, have used health insurance data to reveal the extent of post-operative incontinence and the costs of dealing with it. On a purely financial basis, the information is interesting enough: the average cost of incontinence pads is €210 each year (another study calculated that the 20 year additional cost of incontinence for a man after prostate surgery is close to €50,000).

But more important were the findings about the percentage of men suffering urinary incontinence in the first year after a urology procedure or follow-up. For men undergoing watchful waiting/active surveillance, it was 8%. For those undergoing prostate removal it was 80%, persisting into a second year for 40%.

Patient information about prostate surgery rarely specifies such figures, often offering vague reassurance that “most men” see a quick improvement in continence after surgery – as if it would be wrong to frighten them too much. As more evidence becomes available to fill in the picture on complex decisions, it’s only right that it should be shared with those it affects most.