“Informed choice” in a time of too much medicine—no panacea for ethical difficulties
BMJ 2016; 353 doi: https://doi.org/10.1136/bmj.i2230 (Published 09 May 2016) Cite this as: BMJ 2016;353:i2230All rapid responses
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I really enjoyed the article and agree with the premise.
Deciding if there is more harm or benefit to giving a diagnosis is certainly a challenging question. It certainly may help someone take a problem more seriously if this is required. It helps them access resources that would be appropriate, although someone doesn't need to be told they have depression to benefit resources for depression.
One tool that may help here is the assessment of 'ideas, concerns, expectations'. If someone has come wanting to know what is wrong for example, then giving them a diagnosis is appropriate. If someone has come wanting some form of a management plan or reassurance about a symptom, then here it may be less appropriate to give a diagnosis. Perhaps giving them a diagnosis is giving them something they have not asked for. Of course this is only one factor in many when making these very challenging decisions.
Competing interests: No competing interests
I am unable to access the paper, but I have scanned the responses.
As I have pointed out
http://www.bmj.com/content/350/bmj.h2877/rr-7
the law in England has settled on Informed Consent. The concept behind informed consent, is not 'achieving a 'good' outcome' - rather, it is that 'clinicians inform the patient, and then the patient decides what, if any, of the offered treatments to accept'. It is very difficult - and the more discussions I read, the more I am aware of this - for doctors and nurses to accept this because of their 'instinct to care': but it surely will never be satisfactory, if our law has settled on something, and clinicians are trying to deny that.
Competing interests: No competing interests
We endorse the preference of Dr Timms and Dr Bird for life-style adjustments as the first issues to discuss over what they consider “active treatment” (i.e. medication). However, the time needed to promote such a strategy is not necessarily available to the general practitioner, which makes it attractive to resort to medicalisation. Additionally, few patients succeed in lowering their blood pressure or blood lipids below the values recommended in guidelines through changes in lifestyle, at least in the longer term, and therefore eventually end up discussing medical treatment.
Furthermore, even if medical treatment is never discussed we still find the process of informed choice ethically complicated; we have still (often unrequested) informed our patient about her risk of getting a heart attack if the blood lipids are increased, or a fracture in the case of osteoporosis. We feel we as doctors do not take adequate responsibility for the possible consequences of providing such information.
We are glad to hear that Dr. Timms has not personally experienced stigmatization due to public awareness about his diagnosis of depression, but doubt that this experience can be generalized. Abundant evidence suggests that many diagnoses are associated with stigmatization and impacts personal perception of health and wellbeing. Qualitative studies indicates that being labeled with a diagnosis of asymptomatic osteoporosis,(1) hypertension,(2) hyperlipidemia(3) or abdominal aortic aneurysm(4) can have substantial effects on quality of life, and having a false positive mammogram have measurable psychosocial consequences even after 3 years.(5) Such consequences of labeling are particularly problematic since many diagnoses that we apply today are not clear-cut labels of unambiguous conditions. For example, science cannot provide an answer to whether symptoms of stressful life circumstances should be defined as depression or not, or what level of blood lipids that should be defined as hyperlipidemia, these are value-based decisions. This becomes evident when considering that according to guidelines, 84% of the adult population in Norway, one of the healthiest populations in the world, are labeled as having an increased CVD-risk, i.e. only 16% of the population have a “normal” CVD-risk.(6) In the case of depression, such aspects has also been intensively debated.(7)
We would thus respectfully disagree with Dr. Timms and Dr. Bird and assert that it is quite unlikely that our analysis paper create stigmatization. This is created by societal structures that are difficult, but necessary, to change. Not highlighting the problem of stigmatization out of concerns that this would lead to more stigmatization is a mistake.
We certainly do not argue that the process of “informed choice” is the main cause of medicalisation, only that it can inadvertently legitimize it in the mind of the therapist. There is a tendency today to provide patients and citizens with information that they have not asked for by offering “informed choices” about treatment options or screening participation.(8) Offering choices is perceived as the ultimate respect for individual autonomy. We argue that this focus on providing information and offering choices may sometimes drive doctors into a pathway of diagnostic cascades and medicalisation and that the role of “informed choice” in medicine today needs deeper analysis.
We are not arguing against the notion that doctors should facilitate informed decisions based on patient’s personal preferences or a “collaborative relationship with the patient”. “Laid back” in our paper thus refers to having a less aggressive approach to providing diagnoses and medication, not towards involvement with the patient - on the contrary. As we see it, Dr. Timms and Dr. Bird agree with this assertion.
Minna Johansson, PhD student, University of Gothenburg
Karsten Juhl Jørgensen, senior researcher, Nordic Cochrane Centre
Linn Getz, professor, Norwegian University of Science and Technology
Ray Moynihan, senior research fellow, Bond University
1. Reventlow S, Hvas L, Malterud K. Making the invisible body visible. Bone scans, osteoporosis and women´s bodily experiences. Soc Sci Med 2006;62:2720-31.
2. Sångren H, Reventlow S, Hetlevik I. Role of biographical experience and bodily sensations in patients’ adaptation to hypertension. Patient Educ Couns 2009;74:236-43.
3. Adelswärd V, Sachs L. The meaning of 6.8: numeracy and normality in health information talks. Soc Sci Med 1996;43:1179-87.
4. Hansson A, Brodersen J, Reventlow S, Pettersson M. Opening Pandora’s box: The experiences of having an asymptomatic aortic aneurysm under surveillance. Health, Risk & Society 2012;14,4:341-359.
5. Brodersen J, Siersma VD. Long-term psychosocial consequences of false-positive screening mammography. Ann Fam Med 2013;11:106-15.
6. Petursson H, Getz L, Sigurdsson JA, Hetlevik I. Can individuals with a significant risk for cardiovascular disease be adequately identified by a combination of several risk factors? Modelling study based in the Norweigen HUNT 2 population. J Eval Clin Pract 2009;15:103-9.
7. Dorwick C, Frances A. Medicalising unhappines: new classification of depression risks more patients being put on drug treatment from which tey will not benefit. BMJ 2013;347:f7140.
8. Brownsword R, Earnshaw JJ. The ethics of screening for abdominal aortic aneurysm in men. J Med Ethics 2010;36:827-20.
Competing interests: No competing interests
Dear Sir
We read Johansson et al’s article and found ourselves intrigued with the central notion that the process of informed choice might be generating an over-medicalisation of ordinary life and health experiences. However, we had some problems with it.
Firstly, the case scenario did not really illustrate a downside to informed choice, merely the danger of relying on a crude process of fitting a patient to a diagnostic box rather than engaging actively with him or her. We seriously question whether we would really “feel proud of ourselves” about starting with an offer of active treatment in such a case. We in the UK may sometimes feel encumbered by NICE guidelines but it is clear that for us, for both the cardiac symptoms and emotional distress presented, self-help and life-style adjustment would be the first issues to discuss. This would involve a process of information exchange, explanation and some rather un-dramatic choices for the patient to make. Over-medicalising or empowering? You tell us.
We also take issue with the notion that recording a diagnosis of depression in a person’s records necessarily has such toxic consequences that it generates an ethical problem in making the diagnosis. We don’t see that a diagnosis of “previously, medically treated hypertension,” is any more or less likely to generate inappropriate medicalisation. On a personal note, PT has had a diagnosis of depression which has been medically treated, shared with 4 million people on a television programme (watched by some of his patients) and which has proved never to be any kind of burden or difficulty.
Lastly, the notion that the answer to over-diagnosis is for the doctor to be bit more “laid-back”. We agree that doctors need to “really listen” but would argue that it is much more active than the glib invocation offered here. It involves a number of very active skills that include active listening, motivational interviewing, negotiating and the willingness to explore sensitive areas of cultural difference. Only these can generate an active and bi-directional engagement of doctor and patient. There are a few doctors who seem to do these things almost automatically - but for most of us these are skills that need to be actively learnt and maintained. Laid back? We think not.
So, aside from their stigmatising comments about psychiatric diagnosis and their naive comments about conversational interventions, it seems to us that the authors have, like Don Quixote, tilted at a windmill. The villain of the piece is not informed choice but a reliance on diagnosis to the exclusion of an active and collaborative relationship with the patient.
Dr Philip Timms FRCPsych
Consultant psychiatrist, START team, 1, St Giles House, London SE1 7UD
South London & Maudsley NHS Trust
Dr Jacob Bird MRCPsych
ST4 psychiatrist, START team, 1, St Giles House, London SE1 7UD
South London & Maudsley NHS Trust
Competing interests: No competing interests
The article by Johansson et al. (1) discusses informed choice in the context of the medicalization of society. The authors discuss the role of emotions, cultural influences, and guilty feelings when making a health choice, underlying the common beliefs that “more is better”, “prevention is better than cure”, and the harm that can be done by information about a disease when a person is asymptomatic. The cost of preventive medicine instead of curing people who are already ill is noted.
We agree with the call for reflection about the possible negative effects of informed choice, considering the pervasive environment in which medicine is supposed to fix all (health) problems. Since the landscape is permeated by the many interests at stake, some initiatives support the production of relevant information from valuable research, and of independent information involving patients and the public, fostering a different view of medicine. (2-4)
In line with the analysis by Johansson et al. and promoting a broader role of society in public health decisions, (5-6) citizen juries could be one way to guide screening policy, particularly on cancer. (7) People are consulted to express their opinions and deliberate about the pros and cons of screenings, before single citizens find themselves in a situation with no way of avoiding making a choice. (1)
Informed choice would be made first from a public perspective, engaging the public before implementing an intervention. In line with this idea, the Laboratory of consumer involvement at the IRCCS Mario Negri Institute organized four citizen juries. One on PSA as an individual screening test for prostate cancer in men, (8) and three on carrier screening for cystic fibrosis. (9) Like in one organized in Australia, the jury was not in favor of PSA screening, (8, 10) a finding outside the “more is better” framework. The juries on cystic fibrosis carrier screening, however, were in favor of the screening, underlying the value of letting people make informed reproductive choices. These findings were not expected, in one sense, and suggest that the engagement of the public, being informed in a balanced and transparent way, could lead to different views from the mainstream.
On the other hand, when mass screening programs are actually offered, ethical concerns are a particular issue, especially when the balance between advantages and disadvantages is widely debated, such as for breast cancer screening. (11) Unbiased, complete information should also cover the controversies, (12) so we are developing a decision aid that deals with overdiagnosis and controversies, that will be tested in a randomized trial within a project funded by The Italian Association for Cancer Research. (13)
Finally, we strongly agree with the need to promote a culture that critically appraises the process and interests defining the borders of disease and normality, moving beyond the narrow landscape of medicine when dealing with life and health.
e-mail: cinzia.colombo@marionegri.it
References
1. Johansson M, Jørgensen KJ, Getz L, Moynihan R. "Informed choice" in a time of too much medicine-no panacea for ethical difficulties. BMJ. 2016;353:i2230. doi: 10.1136/bmj.i2230.
2. Chalmers I, Bracken MB, Djulbegovic B, Garattini S, Grant J, Gülmezoglu AM, Howells DW, Ioannidis JP, Oliver S. How to increase value and reduce waste when research priorities are set.
Lancet 2014;383(9912):156-65. doi: 10.1016/S0140-6736(13)62229-1.
3. The International Patient Decision Aid Standards (IPDAS) Collaboration. Available at: http://ipdas.ohri.ca/. Accessed 7 June 2016.
4. Colombo C, Filippini G, Synnot A, Hill S, Guglielmino R, Traversa S, Confalonieri P, Mosconi P, Tramacere I. Development and assessment of a website presenting evidence-based information for people with multiple sclerosis: the IN-DEEP project. BMC Neurol 2016;16(1):30. doi: 10.1186/s12883-016-0552-0.
5. Colombo C, Liberati A, Satolli R, Mosconi P. Citizens’ juries in health care BMJ 2010;341:c5141
6. Moynihan R. Who benefits from treating prehypertension? BMJ 2010;341:c4442.
7. Rychetnik L, Carter SM, Abelson J, Thornton H, Barratt A, Entwistle VA, Mackenzie G, Salkeld G, Glasziou P. Enhancing Citizen Engagement in Cancer Screening Through Deliberative Democracy. J Natl Cancer Inst 2013;105(6):380-6. doi: 10.1093/jnci/djs649.
8. Mosconi P, Colombo C, Satolli R, Carzaniga S, Steering Commitee and the Scientific Committee. Involving a citizens' jury in decisions on individual screening for prostate cancer. PLoS One 2016; 11 : e0143176.
9. Mosconi P, Castellani C, Villani W, Satolli R. Cystic fibrosis: to screen or not to screen? Involving a Citizens’ jury in decisions on screening carrier. Health Expect 2014;18:1956-1967.
10. Rychetnik L, Doust J, Thomas R, Gardiner R, Mackenzie G, Glasziou P. A Community Jury on PSA screening: what do well-informed men want the government to do about prostate cancer screening--a qualitative analysis. BMJ Open 2014;4(4):e004682. doi: 10.1136/bmjopen-2013-004682.
11. Hersch J, Barratt A, Jansen J, Irwig L, McGeechan K, Jacklyn G, Thornton H, Dhillon H, Houssami N, McCaffery K. Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: a randomised controlled trial. Lancet 2015; 385(9978):1642-52. doi: 10.1016/S0140-6736(15)60123-4.
12. Forbes LJ1, Ramirez AJ2; Expert group on Information about Breast Screening. Offering informed choice about breast screening. J Med Screen. 2014;21(4):194-200. doi: 10.1177/0969141314555350.
13. Summary of the project available at: http://www.partecipasalute.it/cms/files/AIRC_2015%20Abstract(1).pdf
Competing interests: No competing interests
One of the best articles ever! On a topic close to my heart. I used to tell colleagues that the only truly informed patient is a medically trained statistician who is not feeling nauseated.
Competing interests: No competing interests
This analysis paper (1) struck a chord with my recent experience regarding the recruitment drive for dementia research. There is a focus on this area, perhaps amongst other reasons influenced by International Dementia Summits and the intervention of our own Prime Minister (2).
Research into the pathologies of dementias is undoubtedly very important. As a professional involved in the care of those currently living with dementia, I also want to see research into ways of helping individuals to live well with dementia.
The authors’ identification of five areas of difficulty in “informed choice” has crystallised for me the issues that concern me about the recruitment process for dementia research.
The pathological basis of Alzheimer’s disease (considered as the leading cause of dementia and therefore the focus of most research) is far from certain (3) and the worldwide research community is recognising this with a shift of focus towards understanding the risk factors involved in dementia. Judging from the contents of the information leaflets I have seen, researchers have found it difficult to convey this uncertainty and to clarify the difference between risk and disease to potential trial participants. The concern I have is that research looking at preventive strategies may be confused by participants as investigating cures for established disease.
There are also longstanding problems, across medicine, of research criteria being adopted in a clinical environment before their clinical utility has been established (4). Again my concern is that this is not being adequately communicated to potential trial participants. This also applies to the community of healthcare professionals who are being asked to support research (5).
The research and clinical communities need to work together to ensure that we take account of the above challenges and to direct our inevitably scarce resources proportionately.
References:
(1) Johansson, M., Jørgensen, K. J., et al. Analysis: “Informed choice” in a time of too much medicine—no panacea for ethical difficulties. BMJ 2016;353:i2230
(2) Cameron, D. The Prime Minister’s Challenge on Dementia. Policy paper Published 26 March 2012 https://www.gov.uk/government/publications/prime-ministers-challenge-on-...
(3) Ballard, C. et al. Alzheimer’s disease, Lancet 2011 Mar 19;377(9770):1019-31
(4) Le Couteur, D.G, Brayne, C. et al. Political drive to screen for pre-dementia: not evidence based and ignores the harms of diagnosis. BMJ2013;347:f5125
(5) Gordon, P., Gordon, S. Letter: Confusion is everywhere. BMJ 2013;346:f511
Competing interests: I have petitioned the Scottish Parliament to consider introducing a Sunshine Act for Scotland: http://www.parliament.scot/GettingInvolved/Petitions/sunshineact
Johansson et al’s ethical concerns for “informed choice” about healthcare warrant comment as basic prerequisites are too poorly implemented.
First, evidence-based tools providing simple pictographs that use absolute numbers with a consistent denominator (ie. /1000 persons), time frames, and visuals employing the same scale for information on gains and losses of the options are too rarely available.(2)
Second, even the simple 4-steps method is rarely implemented by healthcare professionals: 1) Indicate that all options are acceptable; 2) administer the information (as above); 3) promote active participation of the person by the expression of his or her values; 4) analyse if the person is comfortable with the decision by rephrasing.(3)
Third, a critical issue for balanced information is independency.(4) Initiatives such as the Patient-Centered Outcomes Research Trust Fund (http://www.pcori.org/research-results/2013/development-and-user-testing-...) and the Harding Center for Risk Literacy (https://www.mpib-berlin.mpg.de/en/research/harding-center) must be pledged.
Last, but not least there is a major semantic misconception. Indeed, Johansson et al, in the introduction called for “open discussion of risks and benefits of different options.” This wrongly suggests that benefits are definite while harms are not. Accordingly, appropriate wording should be “risks of harm and potential for benefit” or “harm-to-benefit ratio”. This is a major problem: Pubmed searches hit 2610 for "benefit-risk ", 1218 for "benefit risk ratio", 1103 for “benefit/risk” vs only 7 for "potential benefit" AND "risk of harm", 17 for "benefit-harm ratio".
1 JohanssonM, Jørgensen KJ, Getz L, Moynihan R. “Informed choice” in a time of too much medicine—no panacea for ethical difficulties BMJ 2016; 353 :i2230.
2 Johansson M, Brodersen J. Informed choice in screening needs more than information. Lancet 2015;385:1597-1599.
3 Braillon A, Bewley S. Shared Decision-Making for cancer ccreening: Visual tools and a 4-Step Method. JAMA Intern Med 2015;175:1862.
4 Barry MJ. The prostate cancer treatment bazaar: comment on ‘‘Physician visits prior to treatment for clinically localized prostate cancer’’. Arch Intern Med. 2010;170:450-2.
Competing interests: No competing interests
Michael H Stone: A defence of my preference for law and not ethics
I think I should cover some of the ethical issues which so exercise many contributors, because I have insistently claimed that ‘we must stick to the law – because it has a clarity lacking within ethics’. I will explain why I am so insistent that ‘we must use law where possible, and try to avoid using ethics’ - I believe explaining that is important, because my stance might be misinterpreted as ‘cold and uncaring’. In fact, my stance on law versus ethics, flows from my observation that ‘medical academic debate’ almost never addresses the issues which bother me, from my ‘live-with relative during end-of-life perspective’. But first I’ll contrast an ‘ethical’ dilemma, with its ‘legal’ analysis.
A patient consults his GP about a chest pain. This pain could have many causes, some of which could only be investigated by diagnostic tests which carry various risks, and also involve the risks of unnecessary action based on ‘false positives’. It isn’t clear whether the patient, even if the GP attempts to explain all of the risks, will properly understand things such as false positive test results: nor is it obvious that the patient will make a decision that would lead to ‘the best clinical outcome’. Ethically – if ‘seeking to achieve the best outcome’ is the objective – this is very complicated, to the point of being impossible to resolve. And ethically, the GP is thinking about the consequences of both his own actions, and his inactions.
Legally, if Informed Consent is the law of the land, the situation is different. To start with, it cannot be assumed that the patient is requesting treatment for his chest pain: prior to the patient’s consent, the patient is merely asking for clinical information relevant to his chest pain, and for treatment options – the ‘information’ part of informed consent. At any point, the patient can say ‘you need not tell me any more – I’ve decided to not ask for this chest pain to be treated, at the moment’. Ideally the patient will listen to a description of the risks of that decision – but the GP cannot force the patient to listen to a description of the risks of ‘walking away’, and neither can the GP be held responsible for the patient’s [possibly very ‘unwise’] decision to walk away. For so long as the consultation continues, the GP must provide [‘theoretically in law’ – the practicalities of this seem a little unclear, as indeed does the legal interpretation] all of the clinical information which might affect the way the patient decides. Then the patient alone provides the ‘consent’ part of informed consent, and the patient ‘deciding unwisely’ is not the GP’s fault.
The reason I am so keen on people sticking to the informed consent described in our English law, is not that I am ‘against happy endings’, nor am I sanguine about young adults, ‘exercising their legal right to kill themselves’. I am so insistent about the application of informed consent, because I became involved not in a general ‘ethical debate’, but in a debate about end-of-life behaviour. And the ethics which many professionals seem to apply during end-of-life, offend me. I am offended that most guidance seems to imply that if a terminal patient has clearly expressed a refusal of a future treatment to a member of his family, ‘somehow this counts less than if he had expressed it to a GP’. I am offended that even if I write a very clearly worded Advance Decision refusing cardiopulmonary resuscitation irrespective of why I arrest, if I arrest at home and the death could not be certified, attending 999 paramedics would be likely to ignore my instruction and would probably attempt CPR. I am offended that for known end-of-life but not yet ‘expected’ home deaths, the police tend to become involved, and to treat the family as if they are suspects – but I feel sure that deaths which happen in identical clinical situations, but in hospital, do not result in the police attending and interrogating the nursing staff. These things all offend me, and they also ‘offend my ethics’. My ethics include things such as ‘no accusation without some evidence’: people should be assumed honest until proven otherwise; decent end-of-life support for patients requires that clinicians and family carers should be working together; etc. So my ethics, appear to be different from the ‘ethics’ of 999 paramedics, police officers, etc.
If my [hypothetical] 82 years old, but seemingly ‘healthy’, father had made it very clear to me that under no circumstances would he want CPR to be attempted, I might not think he was making the ‘right decision’ but I would respect it because it is his life, and he would experience the consequences if he arrested and CPR was attempted – if he collapses, I tell 999 paramedics that he had made it clear to me that he would never want attempted CPR but the paramedics attempt CPR, ‘then I’m not happy with the ethics of 999’.
When EoL patients are at home, and capacity has been lost, discussions about ‘what should happen’ can lead to disputes, for example between a GP and a family carer. The only thing I am 100% certain of, is that a family carer’s ‘well, I’m not going to do that, because my dad made it perfectly clear to me he would have refused [that course of action]’, is legally (and in my opinion morally) correct. It has to be legally correct: because it follows the fundamental ‘a person is sovereign over his or her own body’ legal principle. There is no such clarity, once ‘professional ethics’ [and professional objectives] are applied to disputes between relatives, clinicians and police officers: and while ‘arguing the ethics’ with a GP is one thing, ‘arguing with police officers about ethics’ is a wholly unsatisfactory experience (for a live-with relative), immediately after a death, and when ‘the police officer is confused’.
Mike Stone Contact; mhsatstokelib@yahoo.co.uk
Competing interests: No competing interests