- Email: [email protected]
Partnership and consent in MS treatment choice
Journal of the Neurological Sciences 335 (2013) 5–8
Contents lists available at ScienceDirect
Journal of the Neurological Sciences journal homepage: www.elsevier.com/locate/jns
Partnership and consent in MS treatment choice☆ Jacqueline Palace Clinical Neurology, Oxford University Hospitals Trust, Oxford, United Kingdom
a r t i c l e
i n f o
Article history: Received 22 March 2012 Received in revised form 5 August 2013 Accepted 3 September 2013 Available online 10 September 2013 Keywords: Treatment choice Decision aids Partnership Consent Multiple sclerosis Preference sensitive care
a b s t r a c t It is not only good medical practice to ensure patients are fully involved in their treatment decisions, but it also improves subsequent compliance, and may even be cost effective. However, choosing treatments in MS is becoming increasingly complex, which means that ensuring patients understand all the issues is a challenge and time consuming. Preference sensitive care (which applies to current MS immunomodulatory treatments) is particularly vulnerable to the individual doctor's opinion and there is an onus on the physician to ensure the decision made incorporates the patient's individual values. National patient decision making tools are an appropriate solution to this dilemma and may, in the future, be a legal requirement in consent to treatment. © 2013 Elsevier B.V. All rights reserved.
Contents 1. 2. 3. 4. 5. 6. 7.
Introduction . . . . . . . . . . . . . . . . . . . Ways of making decisions . . . . . . . . . . . . Physician influenced variations in treatment decisions Guidelines for joint decision making . . . . . . . . Patient comprehension . . . . . . . . . . . . . . Decision aids . . . . . . . . . . . . . . . . . . Cultural influences . . . . . . . . . . . . . . . . 7.1. Rules of consent . . . . . . . . . . . . . 7.2. Summary . . . . . . . . . . . . . . . . . Funding statement . . . . . . . . . . . . . . . . . . Conflict of interest statement . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
5 5 6 6 7 7 8 8 8 8 8 8
1. Introduction
2. Ways of making decisions
The way we are required to interact with patients in selecting appropriate treatments is changing, and the range of choice is increasing. This requires us to be aware of the process of decision making, the influences that can affect outcomes, and the hurdles that challenge this being done effectively. This overview outlines models of decision making, the influence that individual doctors' views can have on treatment selection, and the UK General Medical Council guidelines as to how to approach this. The degree of health literacy required to make this possible, and decision making tools, are covered along with cultural influences and legal opinions.
Treatment choice and subsequent compliance is a complex process and highly dependent on the doctor–patient relationship. The manner in which a doctor relates to their patient and family, determines the role each plays in treatment selection. Models of decision making vary [1]. Historically they have followed a paternalistic approach where the doctor makes the decision on behalf of their patient, with only essential information being imparted to the patient. This is no longer an acceptable process due to the recognition that consent to treatment can only be valid if the patient is fully informed and involved in reaching the decision. Greater patient involvement occurs in the ‘Shared Model’ and even more so in the ‘Informed Model’ where the doctor's role is limited to information exchange only. Clearly the models used will vary depending on the patient's wishes and needs as well as the clinical
☆ This submission was part of the 2011 European Charcot Foundation conference. E-mail address: [email protected]. 0022-510X/$ – see front matter © 2013 Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.jns.2013.09.001
6
J. Palace / Journal of the Neurological Sciences 335 (2013) 5–8
problem and expertise of the doctor. Patient preference for the role they wish to play in decision making will vary within and across populations and some patients will prefer a more passive role whereas others choose a collaborative or active option [2]. Additionally the patient's role is likely to be greater where there is equipoise — the existence of options that are in balance in terms of their attractiveness, or that the outcomes are to, a degree at least, equally desirable (or possibly, undesirable) [3]. A hybrid consisting of elements from different models may be appropriately used. Additionally where the patient does not have a capacity to make decisions the medical team will still be responsible for making treatment choices. 3. Physician influenced variations in treatment decisions The evidence that physician bias in treatment selection occurs is convincing although indirect. Marked variability in medical care has been noted over the years, which is in part due to misuse of preference sensitive care. This refers to decision making where there are treatment choices that involve significant trade-offs across the available options which affect length or quality of life. While such treatment choices should be based upon the patient's values and preferences, the marked variations that occur appear to be physician dependent [4]. Back in the 1930s, Glover reported wide variation in tonsillectomy rates among school districts with a specific example of the rate dropping ten-fold when a health officer was replaced in one district. In the 1990s, variations were reported in the proportion of women who undergo lumpectomy versus mastectomy in early stage breast cancer. The conclusion was that it was dependent on the physician's opinion rather than patient's preference. More recently (in 2002–2003) where standardised rates of hip fracture repair in Medicare enrolees were very similar across 306 US hospital referral regions, there was marked variation noted in
rates of certain orthopaedic procedures such as knee and hip replacement and back surgery. This did not relate to the supply of surgeons in the different regions. Within the UK risk sharing scheme, where a choice of four disease modifying treatments (3 different interferon-beta formulations and glatiramer acetate) was available to all 72 prescribing centres, there was marked variability in the relative use of these agents (see Fig. 1). Additionally the percentage of MS specialists in each centre prescribing the disease modifying drugs to patients with secondary progressive (versus relapsing remitting) MS varied from 0% to nearly 50%. These variations are likely to be due to physician preference and opinion and not patient influenced, and the causes for this variation are likely to be complex. Different physician views as to whether equipoise exists in the MS DMT decision is probably the most important factor and this is despite the prescribing being undertaken by neurologists with experience in treating MS. Other possible influences such as physician relationship with the pharmaceutical companies and ease of safety monitoring should be considered, although the latter is not significantly different between the particular products. It is hoped that with greater patient involvement in treatment decisions these site variations will reduce. 4. Guidelines for joint decision making The General Medical Council (GMC) sets out the duties it requires all UK physicians to abide by and in 2008 published guidelines for consenting patients [5] which focussed upon patients and doctors making decisions together. It identified openness, trust and good communication as being paramount in effective doctor–patient relationships and suggested that both have a role in making decisions about treatment and care. Thus it recommends the ‘Shared Care Model’ of decision making with a duty on both parties to be involved.
Fig. 1. Individual UK prescribing sites are shown on the x axis, with the different % on the four drugs prescribed (Betaferon, Rebif 22 or 44, Avonex, Copaxone), shown in the different colours (anonymised as commercially sensitive information) for patients enrolled in the UK multiple sclerosis disease modifying therapy risk sharing scheme. Extreme examples of the use of different individual drugs prescribed are highlighted by asterisks.
J. Palace / Journal of the Neurological Sciences 335 (2013) 5–8
The document divides the process into three basic stages: Assessment of the patient's condition by both the doctor and the patient: This involves the doctor not only eliciting the medical history in order to assess the treatment options available, but also assessing the patient's background knowledge and prior experience, and listening to and respecting the patient's views about their health. Identification and communication of the treatment options: The doctor, using their medical knowledge and experience, needs to then identify the range of treatments that would be beneficial to the patient, including the option of doing nothing, taking into account the patients views and understanding and then relaying this to the patient. This includes explaining the potential benefits of the treatment and the risks and burdens and side effect profiles. It is reasonable for doctors to give recommendations if there is no pressure on the patient to accept these. The decision is then made by the patient. This will have been after they have weighed up the benefits and disadvantages of the treatments and incorporated their individual non-clinical needs and views. If the patient, in the doctor's view, makes a non-beneficial decision, the reasons should be explored. Where the doctor feels strongly against the patient's decision and thus feels unable to provide the treatment option themselves, their reasons should be explained to the patient and the option to seek a second opinion offered (Fig. 2).
7
A literacy assessment of 19,000 adults in 2003 [6] found that 36% of American adults had inadequate health literacy skills with huge cost implications. Such poor health literacy was shown to associate with certain features such as older age, being in an ethnic minority group, having non-English as a first language, having poor educational background, being unemployed or in a low income group and health insurance status. Learning disabilities and visual problems only accounted for a small proportion of cases. Of note, however, the majority were white native born Americans. Additionally, being affluent and successful doesn't guarantee adequate health literacy. In MS additional cognitive, visual, and psychiatric problems will be additional confounders and educational attainment itself plays only a minor role in disease knowledge which appears to be influenced to a greater extent by the use of information aids [8]. Perhaps surprisingly, MS patient risk knowledge plays only a minor role on their preference for taking a more active role in MS treatment decisions [9]. In addition to patient comprehension being crucial for shared decision making and informed treatment consent, it is also likely to improve satisfaction and adherence to treatment [10]. Indeed the poor adherence noted with disease modifying therapies will clearly reduce the treatment effect [11]. Educational strategies to improve patient insight into the expectations of treatment and raise their ability to participate more actively in the decision making process should encourage better adherence.
5. Patient comprehension 6. Decision aids According to the US courts statements [6], consent (to treatment) is not getting a patient to sign a form, but a process of physicians helping patients understand their condition for the purpose of making informed decisions. Patients must have a true understanding of the treatment options and it is the physician's duty to ascertain that the patient understands. However, communicating effectively enough to ensure patient comprehension is an enormous challenge, and inadequate health literacy is a key cause of this failing [6]. Health literacy refers to the ability of patients to obtain, process and understand health information and services needed to make appropriate health decisions and follow instructions for treatment. Modern medicine has become increasingly complex and this demands greater health literacy. The MS disease modifying therapies are a good example of the increasing demands being put upon patients and their doctors in making treatment choices. There has been an increasing range of MS therapies over the past decade with only partial efficacy and different trade-offs. The drugs with greater efficacy are often offset by a greater risk and side effect profile, and the route of administration, frequency of dosage regime, chances of developing neutralising antibodies against the treatment, and formulation stability (and thus storage) differ across individual treatments and are all important factors in treatment choice. It is perhaps not surprising that patients may not grasp all the information they need to make the best decision. Indeed the decision making process involved in choosing MS disease modifying agents requires a high level of numeracy skills in interpreting data which may be partly improved by information aids [7].
Fig. 2. A summary of the key points in the GMC guidelines on consent and partnership in decision making.
Because treatment choice can be complex, and helping patients understand the necessary factors is time consuming and often unsuccessful, decision aids are increasingly used. These prepare patients to participate in decisions and can take the form of pamphlets, videos, or web based tools. These are useful when there is more than one reasonable treatment option and where none has a clear health outcome advantage, where each has benefits and disadvantages, and may vary in their scientific uncertainty i.e. where equipoise exists. Because these factors are valued by individual patients differently, they are preference sensitive. A Cochrane review of patient decision aids [12] evaluated 86 randomised controlled studies measuring the efficacy of these tools. The review concluded that these aids improved the patient's knowledge of the treatment options and led to more accurate expectations of benefits and harm, and more choices in keeping with the patient's own informed values were made. Patients were more likely to participate in decision making and their use had a positive effect on communication and relationship with health professionals. Additionally, patients were less likely to select surgery. There appeared to be no disadvantages. Thus these aids are efficacious and cost effective. These decision making tools are likely to be very useful in satisfying the legal standard of informed consent in the future [13]. Patient information can be imparted in different ways and it is important to evaluate the relative merits of these methods in order to produce evidence based criteria [14]. In 2007 the European Union published a ‘Code of Good Practice’ on the rights of people with MS (EMSP) requiring clear and concise information to empower patients to improve their ability to self-manage their disease. A number of decision making tools have been developed for MS [15–17], which cover relapse treatment, family planning and specific aids for disease modifying drug decisions. In the UK a web based decision tool (www.msdecisions.org.uk) is available where patients are directed to help them select a treatment option that is best for their individual needs and values. However, only the ISDIMSdecision aid [17], which consists of a comprehensive 100-page booklet and a decision support chart, satisfies the criteria for evidence-based patient information which includes the strength of available evidence, patient-relevant outcomes, presentation of risks in absolute numbers, displaying gains and losses together, and uses a reassuring but nonpatronising style [18].
8
J. Palace / Journal of the Neurological Sciences 335 (2013) 5–8
7. Cultural influences Ethnic and cultural differences are likely to influence doctor–patient interactions. A literature review of intercultural observational studies [19] revealed major differences in doctor–patient communication as a result of patients' ethnicity. Doctors interacted less well with patients from ethnic minorities. Additionally ethnic minority patients tend to be less assertive, less verbally expressive and not as good at communicating during the medical encounter. The degree of doctor empathy with patients from different ethnic backgrounds varies and social talk is less with intercultural interactions. Other cultural influences include the role of the family and physician in decision making [20]. This emphasizes the need for clinicians to be aware of these issues.
aids are incorporated. Our duty as doctors is to work in partnership to help patients achieve what is best for them. Funding statement This work was not specifically funded. Conflict of interest statement Dr Palace has received support for scientific meetings and honorariums for advisory committees from Merck Serono, Biogen Idec, Novartis, Teva, and Bayer Schering, and unrestricted grants from Merck Serono and Bayer Schering. References
7.1. Rules of consent In the UK, it is expected that all common and all severe side effects of treatments are adequately explained and that this is documented. Additionally, no-one else has the right to make decisions on behalf of a patient with capacity. If the patient is not able to make decisions for him/herself the doctor must take into consideration any views and preferences expressed by the patient and must follow the law on decision making when a patient lacks capacity. The UK common law states that a person is not to be treated as unable to make a decision merely because he makes an unwise/irrational decision, or places their health and life at risk, or makes a decision that could result in harm to the unborn child. The fact that a person has a mental illness does not automatically mean they lack capacity to make a decision about medical treatment. Patients have capacity if they can understand, believe, retain and weigh the necessary information. However a patient's consent to a particular treatment may not be valid if it is given under pressure or duress exerted by another person and doctors should be alert to outside coercion or pressure on their patients. Patients under the age of 16 years old are ordinarily classified as children and under parental responsibility. However, in 1983 Victoria Gillick lost her case preventing doctors prescribing contraception to under 16 year olds without parental consent. Subsequently, in the UK Law, the parental right to determine their under 16 year old child's medical treatment terminates if and when the child achieves sufficient understanding and intelligence to understand fully what is proposed. The child is then referred to as ‘Gillick competent’. 7.2. Summary It is clear that patients should be involved in making decisions about their own treatment and that this improves outcomes, adherence, and is cost effective. However there is an obligation on the doctor as the expert to ensure their patient is sufficiently informed to do this, and to be aware of the patient's ability to make decisions and of any outside influences that might detrimentally affect this. Because of the complexity of modern treatment decisions and the increasing demands on patient health literacy, the ‘Shared model’ of decision making is likely to lead to the most valid patient choice as long as good patient decision making
[1] Charles C, Whelan T, Gafni A. What do we mean by partnership in making decisions about treatment? BMJ 1999;319:780–2. [2] Giordano A, Mattarozzi K, Pucci E, Leone M, Casini F, Collimedaglia L, et al. Participation in medical decision-making: attitudes of Italians with multiple sclerosis. J Neurol Sci 2008;275:86–91. [3] Elwyn G, Edwards A, Kinnersley P, Grol R. Shared decision making and the concept of equipoise: defining the competences of involving patients in healthcare choices. BJGP 2000;50:892–9. [4] Preference sensitive care. Dartmouth atlas project. Chicago IL: American Hospital Publishing, Inc.; 2007 1–6. [5] Consent: patients and doctors making decisions together. General Medical Council Publication; June 2008. [6] Weiss BD. Health literacy and patient safety: help patients understand. Manual for clinicians 2nd edition. American Medical Association Foundation and American Medical Association; 2007. [7] Kasper J, Köpke S, Mühlhauser I, Heesen C. Evidence-based patient information about treatment of multiple sclerosis. A phase one study on comprehension and emotional responses. Patient Educ Couns 2006;62:56–63. [8] Solari A, Martinelli V, Trojano M, Lugaresi A, Granella F, Giordano A, et al. Confalonieri P and Borreani C on behalf of the SIMS-Trial group* an information aid for newly diagnosed multiple sclerosis patients improves disease knowledge and satisfaction with care. Mult Scler 2010;16(11):1393–405. [9] Heesen C, Kasper J, Segal J, Köpke S, Mühlhauser I. Decisional role preferences, risk knowledge and information interests in patients with multiple sclerosis. Mult Scler 2004;10:643–50. [10] Kessels RPC. Patients' memory for medical information. J R Soc Med 2003;96:219–22. [11] Bruce JR, Lynch SG. MS treatment adherence—how to keep patients on medication? Nat Rev Neurol 2011;7:421–2. [12] Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, et al. Decision aids for people facing health treatment or screening decisions (Cochrane review). The Cochrane collaboration. The Cochrane Library; 2011 . Issue 10 http://www. thecochranelibrary.com. [13] O'Connor AM, Wennberg JE, Legare F, Llewellyn-Thomas HA, Moulton BW, Sepucha KR, et al. Toward the ‘tipping point’: decision aids and informed patient choice. Health Aff 2007;26(3):716–25. [14] Bunge M, Muhlhauser I, Steckelberg A. What constitutes evidence-based patient information? Overview of discussed criteria. Patient Educ Couns 2010;78:316–28. [15] Köpke S, Mühlhauser I. Decision aids in multiple sclerosis. In: Edwards A, Elwyn G, editors. Shared decision making in health care: achieving evidence based patient choice. 2nd ed. Oxford: Oxford University Press; 2009. p. 95–100. [16] Prunty M, Sharpe L, Butow P, Fulcher G. The motherhood choice: a decision aid for women with multiple sclerosis. Patient Educ Couns 2008;71:108–15. [17] Kasper J, Kopke S, Muhlhauser I, Nubling M, Heesen C. Informed shared decision making about immunotherapy for patients with multiple sclerosis (ISDIMS): a randomized controlled trial. Eur J Neurol 2008;15:1345–52. [18] Steckelberg A, Berger B, Köpke S, Heesen C, Mühlhauser I. German. Criteria for evidence-based patient information. Z Arztl Fortbild Qualitatssich 2005;99(6):343–51. [19] Schouten BC, Meeuwesen L. Cultural differences in medical communication: a review of the literature. Patient Educ Couns 2006;64:21–34. [20] Ruhnke GW, Wilson SR, Akamatsu T, Kinoue T, Takashima Y, Goldstein MK, et al. Ethical decision making and patient autonomy. A comparison of physicians and patients in Japan and the United States. Chest 2000;118(4):1172–82.
Contents lists available at ScienceDirect
Journal of the Neurological Sciences journal homepage: www.elsevier.com/locate/jns
Partnership and consent in MS treatment choice☆ Jacqueline Palace Clinical Neurology, Oxford University Hospitals Trust, Oxford, United Kingdom
a r t i c l e
i n f o
Article history: Received 22 March 2012 Received in revised form 5 August 2013 Accepted 3 September 2013 Available online 10 September 2013 Keywords: Treatment choice Decision aids Partnership Consent Multiple sclerosis Preference sensitive care
a b s t r a c t It is not only good medical practice to ensure patients are fully involved in their treatment decisions, but it also improves subsequent compliance, and may even be cost effective. However, choosing treatments in MS is becoming increasingly complex, which means that ensuring patients understand all the issues is a challenge and time consuming. Preference sensitive care (which applies to current MS immunomodulatory treatments) is particularly vulnerable to the individual doctor's opinion and there is an onus on the physician to ensure the decision made incorporates the patient's individual values. National patient decision making tools are an appropriate solution to this dilemma and may, in the future, be a legal requirement in consent to treatment. © 2013 Elsevier B.V. All rights reserved.
Contents 1. 2. 3. 4. 5. 6. 7.
Introduction . . . . . . . . . . . . . . . . . . . Ways of making decisions . . . . . . . . . . . . Physician influenced variations in treatment decisions Guidelines for joint decision making . . . . . . . . Patient comprehension . . . . . . . . . . . . . . Decision aids . . . . . . . . . . . . . . . . . . Cultural influences . . . . . . . . . . . . . . . . 7.1. Rules of consent . . . . . . . . . . . . . 7.2. Summary . . . . . . . . . . . . . . . . . Funding statement . . . . . . . . . . . . . . . . . . Conflict of interest statement . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
5 5 6 6 7 7 8 8 8 8 8 8
1. Introduction
2. Ways of making decisions
The way we are required to interact with patients in selecting appropriate treatments is changing, and the range of choice is increasing. This requires us to be aware of the process of decision making, the influences that can affect outcomes, and the hurdles that challenge this being done effectively. This overview outlines models of decision making, the influence that individual doctors' views can have on treatment selection, and the UK General Medical Council guidelines as to how to approach this. The degree of health literacy required to make this possible, and decision making tools, are covered along with cultural influences and legal opinions.
Treatment choice and subsequent compliance is a complex process and highly dependent on the doctor–patient relationship. The manner in which a doctor relates to their patient and family, determines the role each plays in treatment selection. Models of decision making vary [1]. Historically they have followed a paternalistic approach where the doctor makes the decision on behalf of their patient, with only essential information being imparted to the patient. This is no longer an acceptable process due to the recognition that consent to treatment can only be valid if the patient is fully informed and involved in reaching the decision. Greater patient involvement occurs in the ‘Shared Model’ and even more so in the ‘Informed Model’ where the doctor's role is limited to information exchange only. Clearly the models used will vary depending on the patient's wishes and needs as well as the clinical
☆ This submission was part of the 2011 European Charcot Foundation conference. E-mail address: [email protected]. 0022-510X/$ – see front matter © 2013 Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.jns.2013.09.001
6
J. Palace / Journal of the Neurological Sciences 335 (2013) 5–8
problem and expertise of the doctor. Patient preference for the role they wish to play in decision making will vary within and across populations and some patients will prefer a more passive role whereas others choose a collaborative or active option [2]. Additionally the patient's role is likely to be greater where there is equipoise — the existence of options that are in balance in terms of their attractiveness, or that the outcomes are to, a degree at least, equally desirable (or possibly, undesirable) [3]. A hybrid consisting of elements from different models may be appropriately used. Additionally where the patient does not have a capacity to make decisions the medical team will still be responsible for making treatment choices. 3. Physician influenced variations in treatment decisions The evidence that physician bias in treatment selection occurs is convincing although indirect. Marked variability in medical care has been noted over the years, which is in part due to misuse of preference sensitive care. This refers to decision making where there are treatment choices that involve significant trade-offs across the available options which affect length or quality of life. While such treatment choices should be based upon the patient's values and preferences, the marked variations that occur appear to be physician dependent [4]. Back in the 1930s, Glover reported wide variation in tonsillectomy rates among school districts with a specific example of the rate dropping ten-fold when a health officer was replaced in one district. In the 1990s, variations were reported in the proportion of women who undergo lumpectomy versus mastectomy in early stage breast cancer. The conclusion was that it was dependent on the physician's opinion rather than patient's preference. More recently (in 2002–2003) where standardised rates of hip fracture repair in Medicare enrolees were very similar across 306 US hospital referral regions, there was marked variation noted in
rates of certain orthopaedic procedures such as knee and hip replacement and back surgery. This did not relate to the supply of surgeons in the different regions. Within the UK risk sharing scheme, where a choice of four disease modifying treatments (3 different interferon-beta formulations and glatiramer acetate) was available to all 72 prescribing centres, there was marked variability in the relative use of these agents (see Fig. 1). Additionally the percentage of MS specialists in each centre prescribing the disease modifying drugs to patients with secondary progressive (versus relapsing remitting) MS varied from 0% to nearly 50%. These variations are likely to be due to physician preference and opinion and not patient influenced, and the causes for this variation are likely to be complex. Different physician views as to whether equipoise exists in the MS DMT decision is probably the most important factor and this is despite the prescribing being undertaken by neurologists with experience in treating MS. Other possible influences such as physician relationship with the pharmaceutical companies and ease of safety monitoring should be considered, although the latter is not significantly different between the particular products. It is hoped that with greater patient involvement in treatment decisions these site variations will reduce. 4. Guidelines for joint decision making The General Medical Council (GMC) sets out the duties it requires all UK physicians to abide by and in 2008 published guidelines for consenting patients [5] which focussed upon patients and doctors making decisions together. It identified openness, trust and good communication as being paramount in effective doctor–patient relationships and suggested that both have a role in making decisions about treatment and care. Thus it recommends the ‘Shared Care Model’ of decision making with a duty on both parties to be involved.
Fig. 1. Individual UK prescribing sites are shown on the x axis, with the different % on the four drugs prescribed (Betaferon, Rebif 22 or 44, Avonex, Copaxone), shown in the different colours (anonymised as commercially sensitive information) for patients enrolled in the UK multiple sclerosis disease modifying therapy risk sharing scheme. Extreme examples of the use of different individual drugs prescribed are highlighted by asterisks.
J. Palace / Journal of the Neurological Sciences 335 (2013) 5–8
The document divides the process into three basic stages: Assessment of the patient's condition by both the doctor and the patient: This involves the doctor not only eliciting the medical history in order to assess the treatment options available, but also assessing the patient's background knowledge and prior experience, and listening to and respecting the patient's views about their health. Identification and communication of the treatment options: The doctor, using their medical knowledge and experience, needs to then identify the range of treatments that would be beneficial to the patient, including the option of doing nothing, taking into account the patients views and understanding and then relaying this to the patient. This includes explaining the potential benefits of the treatment and the risks and burdens and side effect profiles. It is reasonable for doctors to give recommendations if there is no pressure on the patient to accept these. The decision is then made by the patient. This will have been after they have weighed up the benefits and disadvantages of the treatments and incorporated their individual non-clinical needs and views. If the patient, in the doctor's view, makes a non-beneficial decision, the reasons should be explored. Where the doctor feels strongly against the patient's decision and thus feels unable to provide the treatment option themselves, their reasons should be explained to the patient and the option to seek a second opinion offered (Fig. 2).
7
A literacy assessment of 19,000 adults in 2003 [6] found that 36% of American adults had inadequate health literacy skills with huge cost implications. Such poor health literacy was shown to associate with certain features such as older age, being in an ethnic minority group, having non-English as a first language, having poor educational background, being unemployed or in a low income group and health insurance status. Learning disabilities and visual problems only accounted for a small proportion of cases. Of note, however, the majority were white native born Americans. Additionally, being affluent and successful doesn't guarantee adequate health literacy. In MS additional cognitive, visual, and psychiatric problems will be additional confounders and educational attainment itself plays only a minor role in disease knowledge which appears to be influenced to a greater extent by the use of information aids [8]. Perhaps surprisingly, MS patient risk knowledge plays only a minor role on their preference for taking a more active role in MS treatment decisions [9]. In addition to patient comprehension being crucial for shared decision making and informed treatment consent, it is also likely to improve satisfaction and adherence to treatment [10]. Indeed the poor adherence noted with disease modifying therapies will clearly reduce the treatment effect [11]. Educational strategies to improve patient insight into the expectations of treatment and raise their ability to participate more actively in the decision making process should encourage better adherence.
5. Patient comprehension 6. Decision aids According to the US courts statements [6], consent (to treatment) is not getting a patient to sign a form, but a process of physicians helping patients understand their condition for the purpose of making informed decisions. Patients must have a true understanding of the treatment options and it is the physician's duty to ascertain that the patient understands. However, communicating effectively enough to ensure patient comprehension is an enormous challenge, and inadequate health literacy is a key cause of this failing [6]. Health literacy refers to the ability of patients to obtain, process and understand health information and services needed to make appropriate health decisions and follow instructions for treatment. Modern medicine has become increasingly complex and this demands greater health literacy. The MS disease modifying therapies are a good example of the increasing demands being put upon patients and their doctors in making treatment choices. There has been an increasing range of MS therapies over the past decade with only partial efficacy and different trade-offs. The drugs with greater efficacy are often offset by a greater risk and side effect profile, and the route of administration, frequency of dosage regime, chances of developing neutralising antibodies against the treatment, and formulation stability (and thus storage) differ across individual treatments and are all important factors in treatment choice. It is perhaps not surprising that patients may not grasp all the information they need to make the best decision. Indeed the decision making process involved in choosing MS disease modifying agents requires a high level of numeracy skills in interpreting data which may be partly improved by information aids [7].
Fig. 2. A summary of the key points in the GMC guidelines on consent and partnership in decision making.
Because treatment choice can be complex, and helping patients understand the necessary factors is time consuming and often unsuccessful, decision aids are increasingly used. These prepare patients to participate in decisions and can take the form of pamphlets, videos, or web based tools. These are useful when there is more than one reasonable treatment option and where none has a clear health outcome advantage, where each has benefits and disadvantages, and may vary in their scientific uncertainty i.e. where equipoise exists. Because these factors are valued by individual patients differently, they are preference sensitive. A Cochrane review of patient decision aids [12] evaluated 86 randomised controlled studies measuring the efficacy of these tools. The review concluded that these aids improved the patient's knowledge of the treatment options and led to more accurate expectations of benefits and harm, and more choices in keeping with the patient's own informed values were made. Patients were more likely to participate in decision making and their use had a positive effect on communication and relationship with health professionals. Additionally, patients were less likely to select surgery. There appeared to be no disadvantages. Thus these aids are efficacious and cost effective. These decision making tools are likely to be very useful in satisfying the legal standard of informed consent in the future [13]. Patient information can be imparted in different ways and it is important to evaluate the relative merits of these methods in order to produce evidence based criteria [14]. In 2007 the European Union published a ‘Code of Good Practice’ on the rights of people with MS (EMSP) requiring clear and concise information to empower patients to improve their ability to self-manage their disease. A number of decision making tools have been developed for MS [15–17], which cover relapse treatment, family planning and specific aids for disease modifying drug decisions. In the UK a web based decision tool (www.msdecisions.org.uk) is available where patients are directed to help them select a treatment option that is best for their individual needs and values. However, only the ISDIMSdecision aid [17], which consists of a comprehensive 100-page booklet and a decision support chart, satisfies the criteria for evidence-based patient information which includes the strength of available evidence, patient-relevant outcomes, presentation of risks in absolute numbers, displaying gains and losses together, and uses a reassuring but nonpatronising style [18].
8
J. Palace / Journal of the Neurological Sciences 335 (2013) 5–8
7. Cultural influences Ethnic and cultural differences are likely to influence doctor–patient interactions. A literature review of intercultural observational studies [19] revealed major differences in doctor–patient communication as a result of patients' ethnicity. Doctors interacted less well with patients from ethnic minorities. Additionally ethnic minority patients tend to be less assertive, less verbally expressive and not as good at communicating during the medical encounter. The degree of doctor empathy with patients from different ethnic backgrounds varies and social talk is less with intercultural interactions. Other cultural influences include the role of the family and physician in decision making [20]. This emphasizes the need for clinicians to be aware of these issues.
aids are incorporated. Our duty as doctors is to work in partnership to help patients achieve what is best for them. Funding statement This work was not specifically funded. Conflict of interest statement Dr Palace has received support for scientific meetings and honorariums for advisory committees from Merck Serono, Biogen Idec, Novartis, Teva, and Bayer Schering, and unrestricted grants from Merck Serono and Bayer Schering. References
7.1. Rules of consent In the UK, it is expected that all common and all severe side effects of treatments are adequately explained and that this is documented. Additionally, no-one else has the right to make decisions on behalf of a patient with capacity. If the patient is not able to make decisions for him/herself the doctor must take into consideration any views and preferences expressed by the patient and must follow the law on decision making when a patient lacks capacity. The UK common law states that a person is not to be treated as unable to make a decision merely because he makes an unwise/irrational decision, or places their health and life at risk, or makes a decision that could result in harm to the unborn child. The fact that a person has a mental illness does not automatically mean they lack capacity to make a decision about medical treatment. Patients have capacity if they can understand, believe, retain and weigh the necessary information. However a patient's consent to a particular treatment may not be valid if it is given under pressure or duress exerted by another person and doctors should be alert to outside coercion or pressure on their patients. Patients under the age of 16 years old are ordinarily classified as children and under parental responsibility. However, in 1983 Victoria Gillick lost her case preventing doctors prescribing contraception to under 16 year olds without parental consent. Subsequently, in the UK Law, the parental right to determine their under 16 year old child's medical treatment terminates if and when the child achieves sufficient understanding and intelligence to understand fully what is proposed. The child is then referred to as ‘Gillick competent’. 7.2. Summary It is clear that patients should be involved in making decisions about their own treatment and that this improves outcomes, adherence, and is cost effective. However there is an obligation on the doctor as the expert to ensure their patient is sufficiently informed to do this, and to be aware of the patient's ability to make decisions and of any outside influences that might detrimentally affect this. Because of the complexity of modern treatment decisions and the increasing demands on patient health literacy, the ‘Shared model’ of decision making is likely to lead to the most valid patient choice as long as good patient decision making
[1] Charles C, Whelan T, Gafni A. What do we mean by partnership in making decisions about treatment? BMJ 1999;319:780–2. [2] Giordano A, Mattarozzi K, Pucci E, Leone M, Casini F, Collimedaglia L, et al. Participation in medical decision-making: attitudes of Italians with multiple sclerosis. J Neurol Sci 2008;275:86–91. [3] Elwyn G, Edwards A, Kinnersley P, Grol R. Shared decision making and the concept of equipoise: defining the competences of involving patients in healthcare choices. BJGP 2000;50:892–9. [4] Preference sensitive care. Dartmouth atlas project. Chicago IL: American Hospital Publishing, Inc.; 2007 1–6. [5] Consent: patients and doctors making decisions together. General Medical Council Publication; June 2008. [6] Weiss BD. Health literacy and patient safety: help patients understand. Manual for clinicians 2nd edition. American Medical Association Foundation and American Medical Association; 2007. [7] Kasper J, Köpke S, Mühlhauser I, Heesen C. Evidence-based patient information about treatment of multiple sclerosis. A phase one study on comprehension and emotional responses. Patient Educ Couns 2006;62:56–63. [8] Solari A, Martinelli V, Trojano M, Lugaresi A, Granella F, Giordano A, et al. Confalonieri P and Borreani C on behalf of the SIMS-Trial group* an information aid for newly diagnosed multiple sclerosis patients improves disease knowledge and satisfaction with care. Mult Scler 2010;16(11):1393–405. [9] Heesen C, Kasper J, Segal J, Köpke S, Mühlhauser I. Decisional role preferences, risk knowledge and information interests in patients with multiple sclerosis. Mult Scler 2004;10:643–50. [10] Kessels RPC. Patients' memory for medical information. J R Soc Med 2003;96:219–22. [11] Bruce JR, Lynch SG. MS treatment adherence—how to keep patients on medication? Nat Rev Neurol 2011;7:421–2. [12] Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, et al. Decision aids for people facing health treatment or screening decisions (Cochrane review). The Cochrane collaboration. The Cochrane Library; 2011 . Issue 10 http://www. thecochranelibrary.com. [13] O'Connor AM, Wennberg JE, Legare F, Llewellyn-Thomas HA, Moulton BW, Sepucha KR, et al. Toward the ‘tipping point’: decision aids and informed patient choice. Health Aff 2007;26(3):716–25. [14] Bunge M, Muhlhauser I, Steckelberg A. What constitutes evidence-based patient information? Overview of discussed criteria. Patient Educ Couns 2010;78:316–28. [15] Köpke S, Mühlhauser I. Decision aids in multiple sclerosis. In: Edwards A, Elwyn G, editors. Shared decision making in health care: achieving evidence based patient choice. 2nd ed. Oxford: Oxford University Press; 2009. p. 95–100. [16] Prunty M, Sharpe L, Butow P, Fulcher G. The motherhood choice: a decision aid for women with multiple sclerosis. Patient Educ Couns 2008;71:108–15. [17] Kasper J, Kopke S, Muhlhauser I, Nubling M, Heesen C. Informed shared decision making about immunotherapy for patients with multiple sclerosis (ISDIMS): a randomized controlled trial. Eur J Neurol 2008;15:1345–52. [18] Steckelberg A, Berger B, Köpke S, Heesen C, Mühlhauser I. German. Criteria for evidence-based patient information. Z Arztl Fortbild Qualitatssich 2005;99(6):343–51. [19] Schouten BC, Meeuwesen L. Cultural differences in medical communication: a review of the literature. Patient Educ Couns 2006;64:21–34. [20] Ruhnke GW, Wilson SR, Akamatsu T, Kinoue T, Takashima Y, Goldstein MK, et al. Ethical decision making and patient autonomy. A comparison of physicians and patients in Japan and the United States. Chest 2000;118(4):1172–82.