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clinical ethics

The Death of Sidaway: Values, Judgments and Informed Consent

15 Mar, 15 | by BMJ

Guest post by Kirsty Keywood (University of Manchester)

On 11th March Nadine Montgomery won her case before the UK Supreme Court to gain compensation for the failure of her obstetrician to warn her of risks associated with the vaginal delivery of a large infant – a risk which she would have averted by requesting a caesarean section.[1] Shortly after his birth, her son was diagnosed with cerebral palsy and a brachial plexus injury, resulting from the occlusion of the placenta during a “very stressful” vaginal delivery.

Nadine Montgomery had diabetes, which increased her chances of giving birth to a larger than average-sized baby. This, in conjunction with her small stature (she was 5 feet tall), indicated a risk that a natural delivery would bring with it a 9-10% chance of shoulder dystocia. Were dystocia to occur, attempts to dislodge the infant’s shoulders through mechanical manoeuvres would generate a risk of occlusion of the umbilical cord resulting in death or cerebral palsy of 0.1%. According to the obstetrician, Dr McLellan, the risk of shoulder dystocia did not merit specific mention in discussions with diabetic patients, because the risk of an adverse event associated with shoulder dystocia was very small indeed.

Mrs Montgomery’s case before the UK Supreme Court hinged on the question of the nature of the obstetrician’s duty to the patient. more…

Does religion deserve a place in secular medicine?

26 Feb, 15 | by bearp

By Brian D. Earp

The latest issue of the Journal of Medical Ethics is out, and in it, Professor Nigel Biggar—an Oxford theologian—argues that “religion” should have a place in secular medicine (click here for a link to the article).

Some people will feel a shiver go down their spines—and not only the non-religious. After all, different religions require different things, and sometimes they come to opposite conclusions. So whose religion, exactly, does Professor Biggar have in mind, and what kind of “place” is he trying to make a case for?

more…

Physicians and Euthanasia: What about Psychiatric Illness, Dementia and Weltschmerz?

18 Feb, 15 | by BMJ

Guest Post by Eva Bolt

In the Netherlands, requests for euthanasia are not uncommon. A physician who grants a request for euthanasia in the Netherlands is not prosecuted if the criteria for due care (described in the Euthanasia Act) are met. An example of one of these criteria is the presence of unbearable suffering without prospect of improvement. Almost all physicians in the Netherlands can conceive of situations in which they would perform euthanasia. However, each request for euthanasia calls for careful deliberation. When confronted with a request, a physician needs to judge the situation from two perspectives. The first is the legal perspective; would this case meet the criteria for due care? To judge this, a physician can fall back on the description of the Euthanasia Act and receives help from a consulting physician. The second perspective is personal; how does the physician feel about performing euthanasia in this situation? Is it in line with his personal values?

Our study shows that cause of the patient’s suffering is one of the aspects that influence the physician’s decision on euthanasia. This is interesting, because the Dutch euthanasia act does not make a distinction between different diseases. In case of suffering with a clear physical cause like cancer, most physicians can conceive of performing euthanasia. However, there are also people who request for euthanasia without suffering from a severe physical cause. In these cases, there are not many physicians who would consider complying with this request. As a consequence, people suffering from a psychiatric disease and early stage dementia with a euthanasia wish will rarely find a physician who would grant their euthanasia request. The same is true for people who are tired of living but who do not suffer from a severe physical disease. Also, most physicians will not consider following advanced euthanasia directives asking for euthanasia in case of advanced dementia.

Concluding, while most Dutch physicians can conceive of granting requests for euthanasia from patients suffering from cancer or other severe physical diseases, this is not the case in patients suffering from psychiatric disease, dementia or being tired of living. This distinction is partly related to the criteria for due care. For instance, some physicians describe that it is impossible to determine the presence of unbearable suffering in a patient with advanced dementia. Other explanations for the distinction are not related to the criteria for due care. For instance, it is understandable that physicians do not agree with performing euthanasia in a patient with advanced dementia who does not fully understand what is happening, even if the patient has a clear advanced euthanasia directive.

Each physician needs to form his or her own standpoint on euthanasia, based on legal boundaries and personal values. We would advise people with a future wish for euthanasia to discuss this wish with their physician in time, and we would advise physicians to be clear about their standpoint on the matter. This can help to prevent disagreement and disappointment.

Read the full paper here.

 

Growing a Kidney Inside a Pig Using your own DNA: The Ethics of ‘Chimera Organs’

6 Nov, 14 | by Iain Brassington

Guest post by David Shaw

Imagine that you’re in dire need of a new kidney. You’re near the top of the waiting list, but time is running out and you might not be lucky enough to receive a new organ from a deceased or living donor. But another option is now available: scientists could take some of your skin cells, and from them derive stem cells that can then be added to a pig embryo. Once that embryo is implanted and carried to term, the resulting pig will have a kidney that is a perfect genetic match to you, and the organ can be transplanted into your body within a few months without fear of immune rejection. Would you prefer to take the risk of waiting for an organ donated by a human, which would require you to take immunosuppressant drugs for the rest of your life? Or would you rather receive a “chimera organ”?

This scenario might seem far-fetched, but it is quite likely to be a clinical reality within a decade or so. Scientists have already used the same technique to grow rat organs inside mice, and it has also been shown to work in different types of pig. Although clinical trials in humans have not yet taken place, using these techniques to create human organs inside animals could solve the current organ scarcity problem by increasing supply of organs, saving thousands of lives each year in Europe alone. As illustrated in the example, organs created in this way could be tailored to the individual patient’s DNA, allowing transplantation without the risk of immune rejection. However, the prospect of growing organs of human origin within (non-human) animals raises several ethical issues, which we explore in our paper.

Although chimera organs are ‘personalised’ and unlikely to be rejected, one of the major concerns about using organs transplanted from animals is the risk of ‘zoonosis’ – the possibility that an animal virus might be transmitted along with the organ, resulting in a new disease that could cause a pandemic. more…

Once More unto the Breach of Covenant?

31 Oct, 14 | by Iain Brassington

The “Military Covenant” is in the news again:

The government is failing to abide by its military covenant, medical experts who treat injured soldiers have said.

Leading professors in psychology and orthopaedics say the healthcare system is not providing veterans with the service they have been promised. […]

The moral obligation to treat veterans should not stop when service ends, the covenant states, saying veterans should receive priority healthcare from the NHS when they are being treated for a condition dating from their time in the armed forces.

The Covenant is set out here; most of it is pretty vague, and what isn’t vague is largely predictable in its tone.  In respect of healthcare, the relevant part is on p 6:

The Armed Forces Community should enjoy the same standard of, and access to, healthcare as that received by any other UK citizen in the area they live. […]  Veterans receive their healthcare from the NHS, and should receive priority treatment where it relates to a condition which results from their service in the Armed Forces, subject to clinical need.

This, at first glance, seems to be saying that members of the forces, and ex-members, should be treated in the same way as everyone else, except that they shouldn’t.  (There’s a fuller version of the statement here.)  The Government repeats this confusing attitude elsewhere: its own website explains that

[i]t’s not about getting special treatment that ordinary citizens wouldn’t receive, or getting a better result. For those that have given the most, such as the injured and the bereaved, we do make an exception

But maybe that’s just a terminological infelicity.

The Covenant itself does not have the status of law (and even if it did, that wouldn’t make any moral difference, unless you happen to think that all law is de facto good law).  However, the Armed Forces Act (2011) does state that the Secretary of State must prepare and present before Parliament every year a report on the covenant; and, according to §343A(3), more…

Paper Preview: Implementation of a Consent for Chart Review and Contact

23 Sep, 14 | by BMJ

Guest post by Irena Druce
Our article “Implementation of a Consent for Chart Review and Contact and its Impact in one Clinical Centre” focuses on issues regarding patient health information privacy and recruitment for medical research studies.  Research studies are an integral part of the advancement of medical therapies; however, recruitment into research studies can be challenging.  In Canada, the use of health information is governed by Personal Health Information Protection Act and at our institution a policy is in place that allows only those health professionals directly in the circle of care access to patient information to further protect patient’s privacy.  This policy could have a potential negative effect on recruitment rates into research studies.  Physicians and other clinical personnel often do not have the time to discuss ongoing research projects with patients as time is spent focusing on the patient’s medical issues.  In addition, there is concern that if  physicians use the information that they gather in a clinical encounter to recruit for research studies, it is equivalent to that physician sharing medical information  with someone who does not have a right to it.

In light of these challenges, the Division of Metabolism and Endocrinology at the University of Ottawa implemented a consent for chart review and contact (CCRC).  The CCRC is a document presented to a patient on their first meeting a new physician.  The CCRC gives permission for the patient’s medical file to be reviewed by research personnel to determine whether a patient is eligible for a research study.  If the patient meets the study criteria, the CCRC also grants permission for the patient to be contacted by research personnel to be provided with the details of the research study so they can decide if they wish to participate.

It has been proposed that patients may feel pressured to agree if a  CCRC is presented on their first meeting a new health professional.   Patients may feel that refusing the CCRC would affect the future care they receive.  Our  paper discusses how we have addressed this possible pitfalls with our CCRC document.

In addition, we performed an analysis to assess the impact the CCRC was having at our institution.  We compared the basic demographics of the patients who did and did not agree to the CCRC.  Furthermore, we analysed our centre’s recruitment rate into a known, ongoing, multi-centre, international trial.  Of the participating centres, we found that our institution had some of the highest recruitment rates into the trial, and that the majority of our patients were being recruited via our novel approach of the CCRC.  It is not certain that the use of a CCRC would consistently translate into higher recruitment, but certainly our experience has been encouraging.  Data suggest that participation in research trials has been decreasing in recent years.  Any measure to preserve recruitment may be beneficial, especially a measure which allows for the conduction of research, without having to sacrifice any patient rights with regards to privacy and confidentiality.

Read the paper here.

 

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Posted in clinical ethics, Guest Post, JME

Adrenaline, Information Provision and the Benefits of a Non-Randomised Methodology

17 Aug, 14 | by Iain Brassington

Guest Post by Ruth Stirton and Lindsay Stirton, University of Sheffield

One of us – Ruth – was on Newsnight on Wednesday the 13th August talking about the PARAMEDIC2 trial.  The trial is a double blind, individually randomised, placebo controlled trial of adrenaline v. normal saline injections in cardiac arrest patients treated outside hospital.  In simpler terms, if a person were to have a cardiac arrest and was treated by paramedics, they would usually get an injection of adrenaline prior to shocks to start the heart.  If that same person was enrolled in this study they would still receive an injection but neither the person nor the paramedic giving the injection would know whether it was adrenaline or normal saline.  The research team is proposing to consent only the survivors for the collection of additional information after recovery from the cardiac arrest.  This study is responding to evidence coming from other jurisdictions that indicates that there might be some significant long term damage caused by adrenaline – specifically that adrenaline saves the heart at the expense of the brain.  It is seeking to challenge the accepted practice of giving adrenaline to cardiac arrest patients.

Our starting position is that we do not disagree with the research team.  These sorts of questions need to be asked and investigated.  The development of healthcare depends on building an evidence base for accepted interventions, and where that evidence base is not forthcoming from the research, the treatment protocols need changing.  This going to be tricky in the context of emergency healthcare, but that must not be a barrier to research.

There are two major ethical concerns that could bring this project to a grinding halt.  One is the opt-out consent arrangements, and the other is the choice of methodology.

Consent, then. more…

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Advance Directives, Critical Interests, and Dementia Research

14 Aug, 14 | by BMJ

Guest post by Tom Buller, Illinois State University

In my paper, “Advance Directives, Critical Interests, and Dementia Research”, I investigate whether advance directives can be applied in the context of dementia research. Consider, for the sake of argument, the following fictional case. William, a 77-year-old man who has moderate to severe dementia. When he was first diagnosed and while still competent he declared on many occasions that he wished to do all he could to help future sufferers of the disease and find a cure for Alzheimer’s, and he repeatedly said that he very much wanted to participate in any clinical trials, even those that might involve hardship and risk. With the full agreement of his family William was enrolled in a five-year clinical trial testing a new treatment for Alzheimer’s that involves.

I think it can be legitimately argued that William has the right to make a future-binding decision to participate in the above trial, for the reasons that justify the use of a decision in the treatment context also apply in the present research context. First, William’s beneficent desire to help future sufferers of Alzheimer’s is part and parcel of his character and what gives his life value. Second, the principle of precedent autonomy is not invalidated by the fact the person is encouraging, rather than, refusing intervention, and that the chosen course of action requires the assistance of others. Third, William’s decision is not invalidated by the fact that it is motivated by beneficence rather than self-interest.

If this analysis is correct, then it would seem that there are good reasons to think that a competent person has the right to decide to participate in future research once competence has been lost, even research that is (significantly) greater than minimal risk.

 

Read the full paper online first here.

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Paternalism up a Mountain

12 Aug, 14 | by Iain Brassington

“Paternalism” is one of those words that has a hell of a lot of power.  On several occasions, I’ve seen it used as a trump to shut down an argument: saying “But that’s paternalism” is, at least sometimes, treated as a way of showing that anyone arguing in favour of the allegedly paternalistic action is an imbecile, and has therefore lost the argument by default.  I suspect that this is due to a bastardisation of the (already iffy) “Georgetown Mantra”; but it does seem to be a position horribly common in medical schools.  It’s also very unsophisticated.  Whether or not something is paternalistic seems to me to be less important than whether it’s justified.  Something might be unjustified, and the reason for that might be because it’s paternalistic; but it doesn’t follow from that that no paternalism could be justified.  In just the same way, too much bleach or bleach in the wrong place is something you’d want to avoid; but it doesn’t follow that you should avoid bleach at all times and at all costs.

I want here to tell you a story based on something that happened just over a week ago. more…

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Intentionally Exposing Patients to HIV: When Might it be Ethical?

7 Jun, 14 | by BMJ

Guest Post by Bram Wispelwey, Ari Zivotofsky, and Alan Jotkowitz

Much has been made of the fact that over the last two decades HIV has transformed from an inevitable, agonising killer into a controllable chronic disease.  But have we reached a point where infecting someone with HIV in order to avoid other, potentially worse health outcomes might be justified?  In the realm of organ transplantation we found that if we are not yet there, perhaps we should be.

Our paper was in part inspired by what many considered a shocking ruling by former Israeli Chief Rabbi Eliyahu Bakshi-Doron, who decreed that it was consistent with Jewish religious law for HIV-negative individuals to receive HIV-positive organ transplants, even if the evidence indicates a possibility for the recipient to contract the disease.  Many considered this opinion premature because only recently had HIV-positive individuals been found to be good candidates for solid organ transplantation, and doctors in South Africa were still in the early research stages of examining kidney transplantation between HIV-positive individuals.  But in examining the ethical considerations of autonomy, beneficence, non-maleficence, and justice, we argue in our paper that Rabbi Bakshi-Doron’s opinion is ethically sound.

Focusing on the history of HIV in transplantation and using a comparison to current practice with regard to another infectious disease, cytomegalovirus, we demonstrate that disallowing HIV-negative candidates from receiving HIV-positive organs would be a significant limit on patient autonomy.  The elimination of the ban on this type of potentially life-saving (and improving) donation may also represent a more socially just option, as it would expand the donor pool and engender cost savings. HIV-positive to HIV-positive donation will soon be a reality in several countries; it’s time to think about going one step further.

 

Read the full paper here.

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