How about personally optimized treatment?

May 6, 2019

Pär SegerdahlIt is well known that patients who are asked to participate in cancer trials are tempted by the therapeutic misconception. They believe they are offered a newer and better treatment, when in fact it is about research into an untested treatment. When researchers use genetic tests to develop personalized oncology, even more misconceptions can arise. I will soon explain. But first, what is personalized cancer treatment? Here is an example.

Patients whose tumor is to be operated may undergo preparatory radiation or chemotherapy. Since the preparatory therapy has severe side effects, one wants to avoid giving it to patients whose tumors do not respond to it. The challenge is to distinguish patients who respond to treatment from patients who do not. This is to be accomplished through, among other things, genetic tests on the tumor cells. If this works, you can develop personalized cancer treatment. Patients with the “right” tumor cell genetics receive the preparatory therapy, while patients who, according to the genetic tests, only get the side effects, with no effect on tumor growth, do not receive the therapy.

What are the misconceptions that can arise in patients who are asked to participate in research on personalized cancer treatment? Here are some examples.

Patients who are told that the researchers will do genetic tests can feel a genetic responsibility to participate, considering their children and grandchildren. They believe the test results may be relevant to close relatives, who may have the same disease genes. However, the tests are done on mutated tumor cells and therefore say nothing about inherited cancer risk. A sense of genetic responsibility can thus be triggered by the word “genetics” and create a genetic misconception of research in personalized oncology.

Other misconceptions have to do with the positive language used to describe personalized medicine. One talks about personally “optimized” treatments, about “tailored” treatments, about treatments that are adapted “to the individual.” This language use is not intended to mislead, but it is easy to see how words such as “optimization” can cause patients to believe that research participation means special treatment benefit.

The biggest challenge is perhaps to explain the research purpose behind the positive language. The aim is to be able in the future to distinguish between patients, to “stratify” them, as it less positively is called. Personally optimized care actually means that some patients do not receive certain treatments. This is, of course, reasonable if genetic tests can show that they have no benefit from the treatments but only get the side effects. However, what do cancer patients themselves say about stratified cancer treatment, where some patients are identified as non-responders and therefore are not offered the same treatment as other patients? Finally, do participants understand that “tailored treatment” is a future goal of the study and not something they are offered to try?

Communication with patients recruited for studies in personalized oncology faces many challenges, as patients are tempted by even more misconceptions than just the well-known therapeutic misconception.

Do you want to know more? Read the German study that inspired this blog post.

Pär Segerdahl

Perry, J., Wöhlke, S., Heßling, A.C., Schicktanz, S. 2017. Why take part in personalised cancer research? Patients’ genetic misconception, genetic responsibility and incomprehension of stratification—an empirical‐ethical examination. Eur J Cancer Care. https://doi.org/10.1111/ecc.12563

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On “truly” understanding the risk

March 12, 2019

Pär SegerdahlIt is a well-known psychological fact that people have great difficulties to understand probabilistic risks. What does it actually mean that the risk of developing breast cancer the next ten years is fifteen percent? In addition to the difficulties of understanding probabilities, mathematical expressions can cause a false appearance of exactitude and objectivity. It is often about uncertain evaluations, but expressed in seemingly definitive figures.

At our Monday seminar, Ulrik Kihlbom discussed another difficulty with understanding risk information. It can be difficult to understand not only the probabilities, but also what it is you risk experiencing. Sometimes, people face enormously complex choices, where the risks are high, but also the benefits. Perhaps you suffer from a serious disease from which you will die. However, there is a treatment, and it may work. It is just that the treatment has such severe side effects that you may die even from the treatment.

Ulrik Kihlbom interviewed physicians treating patients with leukemia. The doctors stated that patients often do not understand the risks of the treatment they are offered. The difficulty is not so much about understanding the risk of dying from the treatment. The patients understand that risk. However, the doctors said, no one who has not actually seen the side effects understand that the treatment can make you so incredibly ill.

Yet, it seems like quite comprehensible side effects: fatigue, serious infections, nausea and vomiting, stomach cramp, diarrhea, skin irritation, pain, and weight loss. Why would patients find it difficult to understand these risks?

Could it be that doctors have too high demands on “real” understanding? Must the patient, in order to “truly” understand the side effects, already have experienced the treatment? According to the doctors, experienced patients are at least easier to inform about the side effects. At the same time, the requirement that one must have had the experiences to really understand them seems too strong.

Rather, says Ulrik Kihlbom, doctors probably notice from the patients’ attitude that some of them underestimate what it is like to experience the side effects. Such attitudes can be sensed. The patients understand verbally that they are at risk of these side effects, but emotionally they do not really understand what the side effects are like, especially when they come together for a long time.

This resembles a general human difficulty. We often neglect how we ourselves are affected by our experiences. We project our present, unaffected self, and think: “I’m strong, I can handle those side effects.” However, when we actually experience the side effects, we are no longer strong! The self is not a constant, but changes with our experiences.

Here, then, it is not the probabilities that cause the difficulties, but the words. We understand the side effects verbally and can easily reproduce them. However, even words can cause a false appearance of objectivity: as if the experiences the words denote would not really reach us at our core. We separate ourselves from what we verbally understand we may experience, as if we could live our lives without being affected… without actually living them.

Ulrik Kihlbom has found a striking example of yet another aspect of the difficulty of understanding risk information. Not only probabilities but also common words such as “nausea” can create characteristic misunderstandings of risk information.

Pär Segerdahl

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Patients find misleading information on the internet

October 30, 2018

Pär SegerdahlIn phase 1 clinical studies of substances that might possibly be used to treat cancer in the future, cancer patients are recruited as research participants. These patients almost always have advanced cancer that no longer responds to the standard treatment.

That research participation would affect the cancer is unlikely. The purpose of a phase 1 study is to determine safe dosage range and to investigate side effects and other safety issues. This will then enable proceeding to investigating the effectiveness of the substance on specific forms of cancer, but with other research participants.

Given that patients often seek online information on clinical trials, Tove Godskesen, Josepine Fernow and Stefan Eriksson wanted to investigate the quality of the information that currently is available on the internet about phase 1 clinical cancer trials in Sweden, Denmark and Norway.

The results they report in the European Journal of Cancer Care are quite alarming. The most serious problem, as I understand it, is that the information conceals risks of serious side effects, and in various ways suggests possible positive treatment outcomes. This lack of accurate language is serious. We are dealing with severely ill patients who easily entertain unrealistic hopes for new treatment options.

To give a picture of the problem, I would like to give a few examples of typical phrases that Godskesen, Fernow and Eriksson found in the information on the internet, as well as their suggestions for more adequate wordings. Noticing the contrast between the linguistic usages is instructive.

One problem is that the information speaks of treatment, even though it is about research participation. Instead of writing “If you are interested in the treatment,” you could write “If you want to participate in the research.” Rather than writing “Patients will be treated with X,” you could write “Participants will be given X.”

The substance being tested is sometimes described as a medicine or therapy. Instead, you can write “You will get a substance called X.”

Another problem is that research participation is described as an advantage and opportunity for the cancer patient. Instead of writing “An advantage of study participation is that…,” one could write “The study might lead to better cancer treatments for future patients.” Rather than writing “This treatment could be an opportunity for you,” which is extremely misleading in phase 1 clinical cancer trials, one could more accurately say, “You can participate in this study.”

The authors also tested the readability of the texts they found on the internet. The Danish website skaccd.org had the best readability scores, followed by the Norwegian site helsenorge.no. The Swedish website cancercenter.se got the worst readability scores. The information was very brief and deemed to require a PhD to be understandable.

It is, of course, intelligible that it is hard to speak intelligibly about such difficult things as cancer trials. Not only do the patients recruited as study participants hope for effective treatment. The whole point of the research is effective cancer treatment. This is the ultimate perspective of the research; the horizon towards which the gaze is turned.

The fact, however, is that this horizon is far removed, far away in the future, and is about other cancer patients than those who participate in phase 1 trials. Therefore, it is important not to let this perspective characterize information to patients in whom hope would be unrealistic.

Do not talk about treatments and opportunities. Just say “You can participate in this study.”

Pär Segerdahl

Godskesen, TE, Fernow J, Eriksson S. Quality of online information about phase I clinical cancer trials in Sweden, Denmark and Norway. Eur J Cancer Care. 2018;e12937. https://doi.org/10.1111/ecc.12937

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Ethical competence for the decision not to resuscitate

August 28, 2018

Pär SegerdahlSometimes, physicians have to decide that a cancer patient has such a poor prognosis that he or she should not be resuscitated through cardiopulmonary rescue, if discovered with cardiac arrest. The procedure is violent and would in these cases cause unnecessary suffering.

The situation is stressful for the healthcare team no matter which decision is taken. Providing violent cardiopulmonary rescue to a terminally ill cancer patient can be perceived as poor care at the end of life. At the same time, one wishes of course to treat the patient, so the decision to not resuscitate can be stressful, too. The decision requires ethical competence.

Mona Pettersson, PhD student at CRB, examines in her dissertation the decision not to resuscitate patients in the fields of oncology and hematology. In an article in BMC Medical Ethics, she describes physicians and nurses’ reflections on ethical competence in relation to the decision not to resuscitate. Even if the physician takes the decision, the nurses are involved in the highest degree. They have responsibility for the care of the patient and of the relatives.

The ethical difficulties concern not just the decision itself. The difficulties also concern how patients and relatives are informed about the decision, as well as how the entire healthcare team is informed, involved and functions. What competence is required to ethically handle this care decision? How can such ethical competence be supported?

According to Pettersson, ethical competence involves both personal qualities and knowledge, as well as ability to reflect on how decisions best are made and implemented. In practice, all this interacts. For example, a physician may have knowledge that the patient should be informed about the decision not to resuscitate. At the same time, after reflection, the physician may choose not to inform, or choose to inform the patient using other words.

The physicians and nurses in Mona Pettersson’s study expressed that their ethical competence would be supported by greater opportunities for reflection and discussion of ethics near the end of life within oncology and hematology. This is because healthcare is always situated. The ethical difficulties have a definite context. Healthcare professionals are not ethically competent in general. Their ethical competence is linked to their specific professional practices, which moreover differ for physicians and nurses.

If you want to read more about Mona Pettersson’s dissertation, please read the presentation of her at CRB’s website: Healthcare, ethics and resuscitation.

Pär Segerdahl

Pettersson, M., Hedström. M and Höglund, A. T. Ethical competence in DNR decisions – a qualitative study of Swedish physicians and nurses working in hematology and oncology care. BMC Medical Ethics (2018) 19:63. htdoi.org/10.1186/s12910-018-0300-7

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Inequalities in healthcare – from denial to greater awareness

February 14, 2018

Pär SegerdahlSwedish law prescribes healthcare on equal terms for the whole population. Complying with this law is more difficult than one might believe, since discrimination tends to happen unknowingly, under our own radar.

Telephone nursing has been thought to increase equality in healthcare, because it is so easily accessible. However, research has demonstrated inequalities in telephone counseling. Callers are not treated equally.

Given the role of unawareness in the drama, this is not surprising. Despite the best intentions, treating people equally is very difficult in practice. What can we do about it?

If unawareness is a factor and discrimination largely happens unintentionally, I do not think we can conclude that it must be the result of a “bad system.” Even if discrimination arises unintentionally, it is humans who discriminate. Humans are not just their awareness, but also their unawareness.

In an article in the International Journal of Equity in Health, Anna T. Höglund (and four co-authors) investigates awareness of discrimination in healthcare, especially in telephone nursing. Swedish telephone nurses responded to a questionnaire about discrimination and equal treatment. The nurses’ answers could then be analyzed in terms of four concepts: denial, defense, openness and awareness.

Denial: some nurses denied discrimination. Defense: Some acknowledged that care was not always given on equal terms, but said that measures were taken and that the problem was under control. Openness: some of the nurses found the problem important and wished they could learn more about care on equal terms. Awareness: Some clearly saw how discrimination could occur and gave examples of strategies they used to avoid complex discriminatory patterns of which they were aware.

Rather than explaining unintended discrimination as the result of a “bad system,” these four concepts provide us with tools that can help us handle the problem more responsibly.

Anna T. Höglund proposes two complementary ways of viewing the four concepts. You can see them as positions along a line of development where a person can mature and move from denial or defense, through openness, towards the ultimate goal, awareness. But you can also imagine a person moving back and forth between positions, depending on the circumstances.

One recognizes oneself in these positions; unfortunately, not least in the positions denial and defense. The conceptual model developed in the article increases awareness of discrimination as largely a matter of our awareness and unawareness.

The authors add a fifth concept to the model: Action. If I understand them, they do not mean by “action” correcting a “bad system,” thereby controlling the problem. On the contrary, that would appear very much like expressing the defensive position above. (This indicates how much unawareness there is in many bureaucratic attempts to “control” societal problems through “systems,” to which one later refers: “We have taken appropriate measures, the problem is under control!”)

No, we need to continuously work on the problem; continually address ourselves and our patterns of acting. The conceptual model developed in the article gives us some tools.

Pär Segerdahl

Höglund, A.T., Carlsson, M. Holmström, I.K., Lännerström, L. and Kaminsky, E. 2018. From denial to awareness: a conceptual model for obtaining equity in healthcare. International Journal for Equity in Health 17. DOI 10.1186/s12939-018-0723-2

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Hoping when there is no hope

November 27, 2017

Pär SegerdahlPatients participating in phase I oncology trials have terminal cancer and are near the end of life. Participating in research cannot cure them or even extend their lives. Not only because they have terminal cancer, but also because in phase I trials one tests the safety profile of the treatment, not effectiveness against cancer.

Nevertheless, many patients state that hope is an important reason for them to participate in phase I oncology trials. This is worrying from an ethical perspective. Do they understand what they agree to when they enroll as research participants? Have they been properly informed?

In an article in the Journal of Oncology Practice, Tove Godskesen discusses the issue, together with Ulrik Kihlbom. They argue that it is a norm in cancer care to provide hope to patients, and that this norm may support a tendency in personnel who recruit research participants to not always discourage hope, but rather reinforce it.

Since supporting hope in cancer patients is humanly important, it is not entirely easy to find a solution to the problem. Godskesen and Kihlbom proceed cautiously by distinguishing three kinds of hope that cancer patients may have concerning their participation in phase I trials.

The first is independent hope: patients hope for something that is independent of cure, such as receiving more attention by participating in research. The second kind of hope is realistic hope: patients understand that there is really no hope of cure or prolonged life, but they still hope against hope. The third kind is unrealistic hope: patients misunderstand the situation and think they are offered a treatment that doctors/researchers believe can help.

It is reasonable to support independent and realistic hope in phase I trials, according to Godskesen and Kihlbom. However, unrealistic hope is ethically worrying. It should be discouraged when patients enroll as research participants.

Discouraging unrealistic hope requires awareness of the norm to provide hope to cancer patients. The authors describe how a hopeful attitude is activated simultaneously with the cancer diagnosis. Words like treatment, hope and cure are immediately emphasized in the conversations with patients. The risk is that these words are used in the same hopeful spirit also when participation in a phase I trial is discussed.

Another problem in this context is that patients participating in phase I trials rarely receive palliative care, which would be reasonable given their terminal cancer. This may create the false appearance that research participation means being offered a new treatment. Perhaps the norm to provide hope creates this reluctance to mention palliative care. Staff is afraid that they may discourage hope. That fear is problematic, the authors claim.

What measures do Godskesen and Kihlbom propose? First of all, we need to put extra high demands on the information to participants in phase I oncology trials so that this vulnerable patient group is not exploited. Secondly, the information should contain palliative options. Thirdly, patients should receive palliative counseling throughout the trial.

Integrating research participation with palliative care reduces the risk of encouraging unrealistic hope in this patient group. The fact that trial participation is research and not treatment becomes clearer.

Pär Segerdahl

Godskesen T. and Kihlbom, U. (2017), “I have a lot of pills in my bag, you know”: institutional norms in the provision of hope in phase I clinical cancer trials. Journal of Oncology Practice 13(10): 679-682. DOI: 10.1200/JOP.2017.021832

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Beyond awareness: the need for a more comprehensive ethics of disorders of consciousness

October 23, 2017

Michele FariscoDisorders of consciousness like coma, unresponsive wakefulness syndrome, and what is known as minimally conscious state, are among the most challenging issues in current ethical debates. Ethical analyses of these states usually focus on the ‘residual’ awareness that these patients might still have. Such awareness is taken to have bearing on other factors that are usually considered ethically central, like the patients’ well-being.

Yet, when we take a look at recent scientific investigations of mental activity it appears that things are much more complicated than usually thought. Cognitive science provides empirical evidence that the unconscious brain is able to perform almost all the activities that we (wrongly) think are exclusive of consciousness, including enjoying positive emotions and disregarding negative ones. To illustrate, people that are subliminally exposed to drawings of happy or sad faces are emotionally conditioned in their evaluation of unknown objects, like Chinese characters for people who don’t know Chinese. If preceded by subliminal happy faces, these characters are more likely to elicit positive feelings when consciously perceived. This means that unconscious emotions exist, and these emotions are (plausibly) positive or negative. This in turn suggests that consciousness is not required to have emotions.

Accordingly, people with disorders of consciousness could also have unconscious emotions. Even though they are not capable of external behavior from which we could infer the presence of positive or negative emotional life, we cannot rule out the possibility that these patients’ residual brain activity is related to a residual unaware emotional life, which can be either positive or negative.

We should try to avoid becoming biased by the sort of “consciousness-centrism” that impedes us from seeing the total landscape: there is a lot going on behind (and beyond) the eyes of our awareness.

What does this imply for the ethics of caring for and interacting with people affected by severe disorders of consciousness? Well, as previously said, the ethical discourse surrounding the care for and the relationship with these people has usually focused on their residual awareness, scrutinizing whether and to what extent these people could consciously experience good and bad feelings. Yet if it is possible to have these experiences at the unaware level, shouldn’t this be a relevant consideration when engaging in an ethical analysis of patients with disorders of consciousness? In other words, shouldn’t we take care of their residual unconsciousness in addition to their residual consciousness?

I believe we need to enlarge the scope of our ethical analyses of patients with disorders of consciousness, or at least acknowledge that focusing on residual consciousness is not all we should do, even if it is all we presently can do.

Michele Farisco

Winkielman P., Berridge K.C. Unconscious emotion. Current Directions in Psychological Science. 2004;13(3):120-3

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