European Journal of Internal Medicine 25 (2014) 685–688
Contents lists available at ScienceDirect
European Journal of Internal Medicine journal homepage: www.elsevier.com/locate/ejim
Original Article
Personalised medicine: The cognitive side of patients Ilaria Cutica a,b,⁎, Gordon Mc Vie c, Gabriella Pravettoni a,b a b c
University of Milan, Department of Health Science, Milan, Italy Applied Research Unit for Psycho-oncology, European Institute of Oncology, Milan, Italy European Institute of Oncology, Milan, Italy
a r t i c l e
i n f o
Article history: Received 23 May 2014 Received in revised form 4 July 2014 Accepted 7 July 2014 Available online 21 July 2014 Keywords: Personalised medicine Medical decision making Doctor–patient communication Treatment compliance
a b s t r a c t Background: Although the fashion for the “personalised” or “stratified” approach to medicine is valuable in exploiting the omic signatures of the individual patient, too little attention has been paid to the influence of psychological and cognitive factors in the care process. The aim of this paper is to highlight the importance of those individual psycho-cognitive components in affecting how people act to prevent, cope and react to illness, decide about different therapeutic options, interact with health care providers, and adhere to treatment. Methods: We reviewed the medical and psychological literature about the effect of cognitive and psychological dimensions on treatment efficacy, on patients' global satisfaction, and on treatment compliance. Results: Psychological dimensions have been proved to impact on treatment efficacy, on patients' global satisfaction, and on compliance to treatment. However, there are substantial individual differences among patients; therefore, it is important that physicians recognise how to apply these general recommendations to each individual patient, alongside the omic information emerging from the molecular diagnostic laboratory. Conclusion: The exam of the current literature allows one to derive several strategies which can help health professionals to improve the patients' understanding of their disease and involvement in the whole care process. © 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
1. Introduction Patients are typically seen as passive recipients of care. They have trust in their doctors, comply with treatment decisions and don't ask questions. An important ideal emerging from the development of personalised medicine is to enable patients to be participants and guides in their own health care. Involving patients in treatment related decision-making is in line with the increasingly acknowledged patients' right to autonomy and self-determination. Several studies have assessed patients' wishes within a personalised medicine framework: the possibility to have adequate information and permission to participate in decisions which affect them; the possibility that clinical staff might accord such information with empathy, dignity, and respect; the possibility to be told about the options for treating or managing their condition; and the possibility that their preferences might be taken into account [1,2]. These attributes are important, not only just because people prefer to be treated by clinicians who are good listeners and good at informing, advising, and educating them, but also this type of care may contribute to better health outcomes [3], to a higher adherence to treatment recommendations [4], and to increased trust in health professionals [5].
⁎ Corresponding author at: University of Milan, Department of Health Science, Via Antonio di Rudinì, 8-20142 Milan, Italy. Tel.: +39 0250312240. E-mail address: [email protected] (I. Cutica).
In order to customise patient care, personalised medicine has already led to several changes in the treatment setting, where the efforts by academia and industry have been channelled to both improve diagnostics and prognosis of diseases, and, through the development of biomarkers of drug response and adverse effects, improve the safety and efficacy of those drugs. However, besides the detailed description of both the biological makeup of the individual and the molecular characteristics of the disease, other elements have a relevant role in the process of care, namely patients' cognitive and psychological characteristics. Indeed, the way in which each patient reacts to his/her illness, understands his/ her clinical condition, forms an opinion about possible treatments, adheres to treatments, copes with treatment side effects, and interacts with the whole health care process adds new dimensions to human uniqueness in the same way that genetic information does. Patients' psycho-cognitive aspects also need to be factored into the picture by defining a personal profile of how the patient recognises his/her specific needs and values, habits and behaviours, hopes and fears, beliefs and cognitive dispositions [6]. Psychological dimensions impact on treatment efficacy: the process of integration of patients' goals, preferences and concerns with medical evidence and provider experience leads to highquality medical decisions. A systematic review of 86 clinical trials [7] found that providing patients with clearly presented evidence led to: 1) improved understanding of treatment options and screening recommendations; 2) more accurate expectations of possible benefits and risks; 3) choices more consistent with informed values; and 4) higher patient satisfaction. Patients who are able to seek knowledge, those
http://dx.doi.org/10.1016/j.ejim.2014.07.002 0953-6205/© 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
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who understand what is being communicated, those who can judge what is appropriate to their own situation and able to apply treatments are more likely to have better health outcomes in general. Given these results, to be fully effective personalised medicine needs engaged and informed patients who are encouraged to discuss various treatment options, the possible consequences of those options, and then to arrive at an informed decision about the best action to take. This engagement ensures that patients remain involved in following the various stages of treatment evolution. As a consequence, patients have an increased responsibility to control their own health care; this includes the ability to understand and act on health information (health literacy), and the ability to work together with clinicians to select appropriate treatments or management options (shared decision making). 2. The informed patient: health literacy and understanding information Health literacy entails people's knowledge, motivation and competence to access, understand, appraise and apply health information needed to make judgements and to take decisions concerning healthcare, disease prevention and health promotion [8,9]. It is known that patients with low health literacy tend to have poorer health status, tend to be less likely to adhere to prescribed treatments, to comply with self-care plans, and to experience more drug and treatment errors [10]. A recent review by Berkman and colleagues [11] revealed that low health literacy correlates with a differential use of certain health care services, a decreased participation to screening and influenza immunizations, a poorer ability to correctly take medication, to understand medication labels and health messages and, among elderly persons, higher mortality. However, limited health literacy is not only an issue for vulnerable groups such as the elderly or people with a low level of education. Around 40 to 60% of medical information provided by health practitioners is forgotten within a few minutes, and these percentages increase in old age; furthermore, not all of the information “remembered” is correctly recalled [12]. A recent study revealed that 47% of the general population faced difficulties in understanding, judging and applying information to make decisions regarding their health [13]. Therefore, the route to involving patients in the care process requires that patients are provided with transparent and credible information about their diagnosis, the chance of benefit and the risk of harm from various therapeutic interventions in a more effective manner. Knowledge also confers confidence: patients are more likely to trust their capacity to make decisions when efficiently informed [14]. A recent study showed that 80% of patients want the clinician to tell the truth about their diagnosis, and more than 70% wanted to know the risks associated with each therapeutic option; furthermore, 67% wanted the provider to explain how the options might impact on their quality of life [15]. In addition, patients want information about medicines, firstly to help decision-making, and then to assist ongoing decision-making about the management of those medicines [16]. But the information needs to be given in a language which takes into account the particular aspects which make up the cognitive state of each individual patient. 3. The engaged patient: from good information exchange to engagement The process of involving patients in their care decisions does not only require health literate patients, but also require a “health literate friendly system” which decreases the information and power asymmetry between doctors and patients (i.e. the doctor knows everything, the patient nothing). This means improving patients' grasp of information through a language that is matched to their educational level, and allowing patients to effectively state their own preferences and concerns. In other words, the information exchange needs to be two-way: the health professional provides information to help explain the clinical situation and subsequent decisions, and the patient provides information
on his/her values, preferences, lifestyle, beliefs and previous knowledge about the illness and its treatment [17]. The first type of information flow ensures that all the relevant treatment options are on the table; the second ensures that these could be evaluated by both the healthcare professional and the patient within the context of the patient's specific needs. When this happens, the health professional can create the shared knowledge necessary to consolidate the patient's engagement and to successfully execute the shared decision process. However, it seems that this does not happen as frequently as patients would like. A recent study found that there is a gap between what patients want and what they get with respect to engagement in health care [15]: over 80% of patients strongly want their health care provider to listen to them, but just over half say it actually happens; also, 70% wants their provider to explain the risks of the therapeutic option(s), but this also happens only in half of cases. There is some evidence moreover, that good information exchange within a good healthcare professional–patient relationship could be considered as a therapeutic intervention [18] because it helps in preserving or improving the patient's ability to deal with his/her illness, and even in maintaining a good quality of life. This is particularly relevant in the chronic phase of any disease, as it helps to increase the patient's vitality and social functioning, and to reduce the incidence of depression and anxiety. Further, the possibility of being involved in treatment decision making is of major importance in life-threatening diseases, whose treatment course passes through key decision points, and for those illnesses whose treatment options do not lead to clearcut differences in survival outcome, but which may vary in their impact on the patient's physical and psychological wellbeing [19]. All such considerations apply a fortiori in the case of elderly patients, who often suffer from multiple diseases, comorbidity, frailty, and social isolation [20]; a recent review by Nobili and colleagues [21] illustrates the need for an integrated and comprehensive approach to the care of elderly people, especially among internists. Indeed, it is particularly important that internists take into account the complexity and the overlapping health and social problems of elderly patients, paying attention to genetic and biological factors as well as lifestyle, psychological, cognitive and social characteristics, and to the way these elements interact to determine multimorbidity, or interfere with medication compliance or with the adherence to healthy lifestyle recommendations. To take into account the patients' cognitive and psychological determinants, and to involve patients in the care process, however, does not imply forcing every patient to assume power and responsibility; some patients do not want to share the decision making process with health professionals. In such cases, however, patient engagement is still important in that it encourages patients to provide information about their health and wellbeing values, their information and practical needs, the treatment side effects, and so on. The more engaged the patient, the more abundant and precise will be the information flow from patient to professionals. 4. Health professionals' role in informing and engaging patients On one hand, recent advances in diagnostics facilitate the process of obtaining a precise diagnosis at molecular level, leading to planning the most effective therapeutic strategy, and predicting the most probable prognosis. On the other hand, greater scientific and clinical clarity has prompted growing patients' requests for help in fully understanding the science behind their medical condition, and to be subsequently supported in participating in the care process. A good example is in the unravelling of familial conditions. Despite the increased use of informal sources of information external to the healthcare setting such as the Internet, the patient–health professional interaction still represents a critical juncture for the exchange of health information [22]. What can health professionals do to improve their patients' health literacy and their understanding of their personal disease? Doctors faced with making time to explain diagnostics and pre-treatment tests, and the
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consequent “targetted” medicine. Patients need to be helped in understanding that the path towards obtaining the benefits promised by personalised medicine may require many diagnostic procedures, including possibly more invasive tests. Also, patients need to be helped in keeping and/or increasing their confidence in such diagnostic tests, as reliable instruments for giving correct results — especially when these results are used in making major medical decisions (see also [23]). Healthcare professionals have to deal also with patients' expectations about an innovative treatment, perhaps hyped by the media or the Internet and therefore perceived as of higher quality than traditional treatments. The results of diagnostic omic tests may also indicate that a particular patient is not eligible for a given treatment. This possibility has to be explained to patients at the earliest moment, certainly pretesting. There is thus a danger of patients feeling discriminated against because their genetic makeup is “not right”, and this might lead to a fracture in the communication between patient and health professionals, and subsequent disengagement. It is therefore important to continuously assist patients in understanding clearly the background of any decision made on their treatment. Given that it is the responsibility of health professionals to speak to patients in an easily understandable language, several strategies have been proven to be effective in improving the comprehension of medical terms (for a review: [24]; see also [25]), such as well designed written information used as an adjunct to professional consultation [26]; websites [27]; and targeted mass media campaigns [28]. In particular, the provision of written and electronic information has a beneficial effect on patients' knowledge and understanding of their condition [7], and may help to increase patients' sense of empowerment, and their ability to cope with their illness [29]. However, the effect of printed and electronic material is greater when such information is personalised and reinforced by verbal information from clinicians [4]. A key point in the information exchange between health professionals and patients regards the likelihood of benefit and the risk of harm of a given treatment [30]. The optimum methods for expressing such information have not yet been determined but it appears that information on side effects in numerical form, rather than verbal descriptors, results in a more accurate estimation [16]. There is much less certainty about the presentation of benefit information, with some evidence that, on the contrary, numerical presentation may hinder comprehension due to frequent misunderstanding [31]. In general terms, it seems that the best strategy to communicate risks is ultimately a multifaceted approach that describes both the unwanted outcome and the frequency of that outcome using a combination of techniques, such as qualitative terms, numerical expression, examples from everyday life, and maybe some visual aids such as graphs or booklets (some guidelines to create well designed booklets may be found in [32]). The healthcare professional may select which format is most helpful for a given patient, and build the discussion around that [30]. Such a strategy accommodates patients with different preferences and abilities for understanding risk information. Health professionals should also be aware that information overload may be negative, in that patients try to reduce the cognitive effort required to process all the information by oversimplifying complex situations (for instance not appreciating that both high risk and high benefit coexist: [33]). As a consequence, information overload, or unwanted details, could diminish the logical consistency of patients' thoughts, and even drive patients away from engagement and from participating in decisions [34]. A final point is that the role and degree of patient's preferred involvement in care decisions, as well as the amount of desired information, may vary individually, depending on psychological, cognitive, social and cultural characteristics of each individual patient, as well as upon the characteristics of the healthcare professional–patient relationship [35]. Nonetheless, several studies succeed in identifying the most common information needs: for instance, a review on information needs among cancer patients [36] identified the following 10 categories
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(each divided into several sub-categories): cancer-specific information, treatment-related information, prognosis information, rehabilitation information, surveillance and health information, coping information, interpersonal information, financial/legal information, medical system information, and body image/sexuality information. Each category comprised several sub-categories: for instance, the “rehabilitation information” category comprises: self care issues or home care during recovery; nutrition during recovery; immediate post-treatment follow-up care; long-term side effects of cancer or treatment; recognizing or preventing complications following treatment; recovery time; and where to get medical supplies or medical equipment. However, whilst this is a comprehensive panorama of possible needs, each patient has his/her personal configuration that makes some of these needs more urgent and others almost irrelevant. Indeed, several studies have shown a substantial variation among patients about the ideal amount of information, the type of information that is considered relevant and therefore important, and the purpose of the information [37]. Also, variations in both preferred and actual participation in the care process have been reported (for a review, see [38]); several studies have attempted to determine which factors are associated with a high or low level of desired participation in the decision process: many have shown that higher education level, female sex, and age younger than 45 years are associated with patients' preference for a more active role (for a review, see [39]). In reviewing studies that examined values and preferences of patients considering antithrombotic therapy, MacLean and colleagues [40] found a significant variability in elicited patients' values and preferences regarding both prophylaxis and treatment; however, they also found that some studies' design features (such as the methods used to relay information about risks and benefits of a given treatment), and participant characteristics (such as age, sex, and living situation) may have affected participants' treatment preferences and health status evaluations. 5. Conclusion: recommendations To achieve optimal patient management, personalised medicine requires higher levels of health literacy among patients and the wider population, as well as readiness — and skills — among healthcare professionals to engage more closely with patients over treatment issues and options. Much can be done to promote health literacy among the general population, for instance by public health campaigns, as well as specific campaigns to broaden awareness of personalised medicine. However, much has also to be done by health professionals to widen the health literacy of each patient they interact with, and to encourage them to use it. In this paper, we reviewed the most relevant and shared findings and recommendations to better achieve these aims. At first, physicians should assess patients' health literacy and their knowledge and beliefs about their medical condition, by explicitly asking them what they know about their illness, and what they think about it (that is, for instance, whether they have an idea of the possible causes, or whether they have an idea of the possible therapies). Such issues are also relevant to improve adherence: the more the patient is persuaded about the therapy the more she or he will be committed to it, and the more her/his ideas about the possible causes are correct, the more she/he will be able to avoid such factors in the future (when applicable). Furthermore, the physician should tailor her/his language to the patient's health literacy level, thus improving the patients' comprehension and memory of his/her condition. As a second step, it is necessary to constantly monitor the interaction, evaluating its effect on the patient's comprehension. For instance, does the patient understand what the physician said? Are there any blind spots? The best technique to assess the patient's comprehension (probably to be restricted to doubtful interactions because it is timeconsuming) is to ask the patient to repeat what she/he understood of the information received.
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Finally, as it is important to assess patients' personal configuration of information preferences and needs, and the scope it serves, health professionals should provide patients with room for reflection and for question asking; when this is not enough, physicians may explicitly ask the patient whether she/he wishes to discuss a specific topic. For instance, in a study by Elwyn and colleagues [41] that proposes a set of steps that would enable clinical practitioners (generalists) to appropriately involve patients in decision making, general practitioners found sentences as: “There are several treatments that we could use here and I'll run through them and see which one suits you best” particularly effective to make patient aware that they have the opportunity to participate in the decision making process. Conflict of interest The authors state that they have no conflicts of interest. References [1] Coulter A. What do patients and the public want from primary care? BMJ 2005;331(7526):1199–201. [2] Coulter A. Engaging patients in healthcare. McGraw-Hill Education: New York, NY; 2011. [3] Coulter A. Patient engagement — what works? J Ambul Care Manage 2012;35(2):80–9. [4] Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev 2008;2:2. [5] Keating NL, Green DC, Kao AC, Gazmararian JA, Wu VY, Cleary PD. How are patients' specific ambulatory care experiences related to trust, satisfaction, and considering changing physicians? J Gen Intern Med 2002;17(1):29–39. [6] Gorini A, Pravettoni G. P5 medicine: a plus for a personalized approach to oncology. Nat Rev Clin Oncol 2011;8(7):444. [7] Stacey D, Bennett LL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2011;5(10):CD001431. [8] Kickbusch I, Maag D. Health literacy. In: Kris H, Stella Q, editors. International encyclopedia of public health, vol.3. San Diego: Academic Press; 2008. p. 204–11. [9] Sorensen K, Van Den Broucke S, Brand H, Fullam J, Doyle G, Pelikan, et al. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health 2012;12:80. [10] Institute of Medicine. Health Literacy: a prescription to end confusion. Washinghton DC: National Academic Press; 2004. [11] Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Viera A, Crotty K, et al. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med 2011;155(2):97–107. [12] Kessels RP. Patient's memory for medical information. J R Soc Med 2003;96:219–22. [13] HLS-EU Consortium. Comparative report of health literacy in eight EU member states. The European Health Literacy Survey (HLS-EU). Maastricht: HLS-EU Consortium; 2012 [Online publication: http://www.health-literacy.eu]. [14] Henderson S. Power imbalance between nurses and patients: a potential inhibitor of partnership in care. J Clin Nurs 2003;12(4):501–8. [15] Alston C, Paget L, Halvorson G, Novelli B, Guest J, Mccabe P, et al. Communicating with patients on health care evidence. Discussion Paper. Washington, DC: Institute of Medicine; 2012 [http://www. iom. edu/evidence. 27 Code of Federal Regulations, Protection of human subjects, title 45, sec. 46]. [16] Raynor DK, Blenkinsopp A, Knapp P, Grime J, Nicolson DJ, Pollock K, et al. A systematic review of quantitative and qualitative research on the role and effectiveness of written information about medicines. HTA 2007;11:1–177.
[17] Charles C, Gafni A, Whelan T. Decision-making in the physician-patient encounter: revisiting the shared treatment decision-making model. Soc Sci Med 1999;49(5):651–61. [18] Mossman J, Boudioni M, Slevin M. Cancer information: a cost-effective intervention. Eur J Cancer 1999;35:1587–91. [19] Peters E, Hibbard J, Slovic P, Dieckmann N. Numeracy skill and the communication, comprehension, and use of risk-benefit information. Health Aff 2007;26(3):741–8. [20] Christensen K, Doblhammer G, Rau R, Vaupel JW. Ageing populations: the challenges ahead. Lancet 2009;374(9696):1196–208. [21] Nobili A, Garattini S, Mannucci PM. Multiple diseases and polypharmacy in the elderly: challenges for the internist of the third millennium. J Comorbidity 2011;1(1):28–44. [22] Kennedy A, Gask L, Rogers A. Training professionals to engage with and promote self-management. Health Educ Res 2005;20:567–78. [23] Raynor DK. Health literacy — is it time to shift the focus from patient to provider? BMJ 2012;344:e2188. http://dx.doi.org/10.1136/bmj.e2188. [24] Sudore RL, Schillinger D. Interventions to improve care for patients with limited health literacy. J Clin Outcomes Manag 2009;16(1):20–9. [25] Coulter A, Ellins J. Effectiveness of strategies for informing, educating and involving patients. BMJ 2007;335:24–7. [26] McPherson CJ, Higginson IJ, Hearn J. Effective methods of giving information in cancer: a systematic literature review of randomized controlled trials. J Public Health Med 2001;23:227–34. [27] Gustafson D, Hawkins RP, Boberg EW, McTavish F, Owens B, Wise M. Chess: 10 years of research and development in consumer health information for broad populations, including the underserved. Int J Med Inform 2002;65:169–77. [28] Grilli R, Ramsay C, Minozzi S. Mass media interventions: effects on health services utilization. Cochrane Database Syst Rev 2002;1:1. [29] Wofford JL, Smith ED, Miller DP. The multimedia computer for office-based patient education: a systematic review. Patient Educ Couns 2005;59(2):148–57. [30] Bogardus Jr ST, Holmboe E, Jekel JF. Perils, pitfalls, and possibilities in talking about medical risk. JAMA 1999;281(11):1037–41. [31] Hamrosi K, Dickinson R, Knapp P. It's for your benefit: exploring patients' opinions about the inclusion of textual and numerical benefit information. Int J Pharm Pract 2013;17(2):220–31. [32] Coulter A, Entwistle V, Gilbert D. Sharing decisions with patients: is the information good enough? BMJ 1999;318(7179):318–22. [33] Epstein RM, Peters E. Beyond information exploring patients' preferences. JAMA 2009;302(2):195–7. [34] McCaul DK, Peters E, Nelson W, Stefanek M. Linking decision-making research and cancer prevention and control: important themes. Health Psychol 2005;24(4Suppl.): S106–10. [35] Harris K. The information needs of patients with cancer and their families. Cancer Pract 1998;6:39–46. [36] Rutten LJ, Arora NK, Bakos AD, Aziz N, Rowland J. Information needs and sources of information among cancer patients: a systematic review of research (1980–2003). Patient Educ Couns 2005;57(3):250–61. [37] Jenkins V, Fallowfield L, Saul J. Information needs of patients with cancer: results from a large study in UK cancer centers. Br J Cancer 2001;84:48–51. [38] Tariman JD, Berry DL, Cochrane B, Doorenbos A, Schepp K. Preferred and actual participation roles during health care decision making in persons with cancer: a systematic review. Ann Oncol 2010;21:1145–51. [39] Singh JA, Sloan JA, Atherton PJ, Smith T, Hack TF, Huschka MM, et al. Preferred roles in treatment decision making among patients with cancer: a pooled analysis of studies using the control preferences scale. Am J Manag Care 2010;16(9):688–96. [40] MacLean S, Mulla S, Akl EA, Jankowski M, Vandvik PO, Ebrahim S, et al. Patient values and preferences in decision making for antithrombotic therapy: A systematic review. Antithrombotic therapy and prevention of thrombosis: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012;141(2 suppl.):e1S-23S. [41] Elwyn G, Edwards A, Kinnersley P, Grol L. Shared decision making and the concept of equipoise: the competences of involving patients in healthcare choices. Br J Gen Pract 2000;50(460):892–9.
Contents lists available at ScienceDirect
European Journal of Internal Medicine journal homepage: www.elsevier.com/locate/ejim
Original Article
Personalised medicine: The cognitive side of patients Ilaria Cutica a,b,⁎, Gordon Mc Vie c, Gabriella Pravettoni a,b a b c
University of Milan, Department of Health Science, Milan, Italy Applied Research Unit for Psycho-oncology, European Institute of Oncology, Milan, Italy European Institute of Oncology, Milan, Italy
a r t i c l e
i n f o
Article history: Received 23 May 2014 Received in revised form 4 July 2014 Accepted 7 July 2014 Available online 21 July 2014 Keywords: Personalised medicine Medical decision making Doctor–patient communication Treatment compliance
a b s t r a c t Background: Although the fashion for the “personalised” or “stratified” approach to medicine is valuable in exploiting the omic signatures of the individual patient, too little attention has been paid to the influence of psychological and cognitive factors in the care process. The aim of this paper is to highlight the importance of those individual psycho-cognitive components in affecting how people act to prevent, cope and react to illness, decide about different therapeutic options, interact with health care providers, and adhere to treatment. Methods: We reviewed the medical and psychological literature about the effect of cognitive and psychological dimensions on treatment efficacy, on patients' global satisfaction, and on treatment compliance. Results: Psychological dimensions have been proved to impact on treatment efficacy, on patients' global satisfaction, and on compliance to treatment. However, there are substantial individual differences among patients; therefore, it is important that physicians recognise how to apply these general recommendations to each individual patient, alongside the omic information emerging from the molecular diagnostic laboratory. Conclusion: The exam of the current literature allows one to derive several strategies which can help health professionals to improve the patients' understanding of their disease and involvement in the whole care process. © 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
1. Introduction Patients are typically seen as passive recipients of care. They have trust in their doctors, comply with treatment decisions and don't ask questions. An important ideal emerging from the development of personalised medicine is to enable patients to be participants and guides in their own health care. Involving patients in treatment related decision-making is in line with the increasingly acknowledged patients' right to autonomy and self-determination. Several studies have assessed patients' wishes within a personalised medicine framework: the possibility to have adequate information and permission to participate in decisions which affect them; the possibility that clinical staff might accord such information with empathy, dignity, and respect; the possibility to be told about the options for treating or managing their condition; and the possibility that their preferences might be taken into account [1,2]. These attributes are important, not only just because people prefer to be treated by clinicians who are good listeners and good at informing, advising, and educating them, but also this type of care may contribute to better health outcomes [3], to a higher adherence to treatment recommendations [4], and to increased trust in health professionals [5].
⁎ Corresponding author at: University of Milan, Department of Health Science, Via Antonio di Rudinì, 8-20142 Milan, Italy. Tel.: +39 0250312240. E-mail address: [email protected] (I. Cutica).
In order to customise patient care, personalised medicine has already led to several changes in the treatment setting, where the efforts by academia and industry have been channelled to both improve diagnostics and prognosis of diseases, and, through the development of biomarkers of drug response and adverse effects, improve the safety and efficacy of those drugs. However, besides the detailed description of both the biological makeup of the individual and the molecular characteristics of the disease, other elements have a relevant role in the process of care, namely patients' cognitive and psychological characteristics. Indeed, the way in which each patient reacts to his/her illness, understands his/ her clinical condition, forms an opinion about possible treatments, adheres to treatments, copes with treatment side effects, and interacts with the whole health care process adds new dimensions to human uniqueness in the same way that genetic information does. Patients' psycho-cognitive aspects also need to be factored into the picture by defining a personal profile of how the patient recognises his/her specific needs and values, habits and behaviours, hopes and fears, beliefs and cognitive dispositions [6]. Psychological dimensions impact on treatment efficacy: the process of integration of patients' goals, preferences and concerns with medical evidence and provider experience leads to highquality medical decisions. A systematic review of 86 clinical trials [7] found that providing patients with clearly presented evidence led to: 1) improved understanding of treatment options and screening recommendations; 2) more accurate expectations of possible benefits and risks; 3) choices more consistent with informed values; and 4) higher patient satisfaction. Patients who are able to seek knowledge, those
http://dx.doi.org/10.1016/j.ejim.2014.07.002 0953-6205/© 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
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who understand what is being communicated, those who can judge what is appropriate to their own situation and able to apply treatments are more likely to have better health outcomes in general. Given these results, to be fully effective personalised medicine needs engaged and informed patients who are encouraged to discuss various treatment options, the possible consequences of those options, and then to arrive at an informed decision about the best action to take. This engagement ensures that patients remain involved in following the various stages of treatment evolution. As a consequence, patients have an increased responsibility to control their own health care; this includes the ability to understand and act on health information (health literacy), and the ability to work together with clinicians to select appropriate treatments or management options (shared decision making). 2. The informed patient: health literacy and understanding information Health literacy entails people's knowledge, motivation and competence to access, understand, appraise and apply health information needed to make judgements and to take decisions concerning healthcare, disease prevention and health promotion [8,9]. It is known that patients with low health literacy tend to have poorer health status, tend to be less likely to adhere to prescribed treatments, to comply with self-care plans, and to experience more drug and treatment errors [10]. A recent review by Berkman and colleagues [11] revealed that low health literacy correlates with a differential use of certain health care services, a decreased participation to screening and influenza immunizations, a poorer ability to correctly take medication, to understand medication labels and health messages and, among elderly persons, higher mortality. However, limited health literacy is not only an issue for vulnerable groups such as the elderly or people with a low level of education. Around 40 to 60% of medical information provided by health practitioners is forgotten within a few minutes, and these percentages increase in old age; furthermore, not all of the information “remembered” is correctly recalled [12]. A recent study revealed that 47% of the general population faced difficulties in understanding, judging and applying information to make decisions regarding their health [13]. Therefore, the route to involving patients in the care process requires that patients are provided with transparent and credible information about their diagnosis, the chance of benefit and the risk of harm from various therapeutic interventions in a more effective manner. Knowledge also confers confidence: patients are more likely to trust their capacity to make decisions when efficiently informed [14]. A recent study showed that 80% of patients want the clinician to tell the truth about their diagnosis, and more than 70% wanted to know the risks associated with each therapeutic option; furthermore, 67% wanted the provider to explain how the options might impact on their quality of life [15]. In addition, patients want information about medicines, firstly to help decision-making, and then to assist ongoing decision-making about the management of those medicines [16]. But the information needs to be given in a language which takes into account the particular aspects which make up the cognitive state of each individual patient. 3. The engaged patient: from good information exchange to engagement The process of involving patients in their care decisions does not only require health literate patients, but also require a “health literate friendly system” which decreases the information and power asymmetry between doctors and patients (i.e. the doctor knows everything, the patient nothing). This means improving patients' grasp of information through a language that is matched to their educational level, and allowing patients to effectively state their own preferences and concerns. In other words, the information exchange needs to be two-way: the health professional provides information to help explain the clinical situation and subsequent decisions, and the patient provides information
on his/her values, preferences, lifestyle, beliefs and previous knowledge about the illness and its treatment [17]. The first type of information flow ensures that all the relevant treatment options are on the table; the second ensures that these could be evaluated by both the healthcare professional and the patient within the context of the patient's specific needs. When this happens, the health professional can create the shared knowledge necessary to consolidate the patient's engagement and to successfully execute the shared decision process. However, it seems that this does not happen as frequently as patients would like. A recent study found that there is a gap between what patients want and what they get with respect to engagement in health care [15]: over 80% of patients strongly want their health care provider to listen to them, but just over half say it actually happens; also, 70% wants their provider to explain the risks of the therapeutic option(s), but this also happens only in half of cases. There is some evidence moreover, that good information exchange within a good healthcare professional–patient relationship could be considered as a therapeutic intervention [18] because it helps in preserving or improving the patient's ability to deal with his/her illness, and even in maintaining a good quality of life. This is particularly relevant in the chronic phase of any disease, as it helps to increase the patient's vitality and social functioning, and to reduce the incidence of depression and anxiety. Further, the possibility of being involved in treatment decision making is of major importance in life-threatening diseases, whose treatment course passes through key decision points, and for those illnesses whose treatment options do not lead to clearcut differences in survival outcome, but which may vary in their impact on the patient's physical and psychological wellbeing [19]. All such considerations apply a fortiori in the case of elderly patients, who often suffer from multiple diseases, comorbidity, frailty, and social isolation [20]; a recent review by Nobili and colleagues [21] illustrates the need for an integrated and comprehensive approach to the care of elderly people, especially among internists. Indeed, it is particularly important that internists take into account the complexity and the overlapping health and social problems of elderly patients, paying attention to genetic and biological factors as well as lifestyle, psychological, cognitive and social characteristics, and to the way these elements interact to determine multimorbidity, or interfere with medication compliance or with the adherence to healthy lifestyle recommendations. To take into account the patients' cognitive and psychological determinants, and to involve patients in the care process, however, does not imply forcing every patient to assume power and responsibility; some patients do not want to share the decision making process with health professionals. In such cases, however, patient engagement is still important in that it encourages patients to provide information about their health and wellbeing values, their information and practical needs, the treatment side effects, and so on. The more engaged the patient, the more abundant and precise will be the information flow from patient to professionals. 4. Health professionals' role in informing and engaging patients On one hand, recent advances in diagnostics facilitate the process of obtaining a precise diagnosis at molecular level, leading to planning the most effective therapeutic strategy, and predicting the most probable prognosis. On the other hand, greater scientific and clinical clarity has prompted growing patients' requests for help in fully understanding the science behind their medical condition, and to be subsequently supported in participating in the care process. A good example is in the unravelling of familial conditions. Despite the increased use of informal sources of information external to the healthcare setting such as the Internet, the patient–health professional interaction still represents a critical juncture for the exchange of health information [22]. What can health professionals do to improve their patients' health literacy and their understanding of their personal disease? Doctors faced with making time to explain diagnostics and pre-treatment tests, and the
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consequent “targetted” medicine. Patients need to be helped in understanding that the path towards obtaining the benefits promised by personalised medicine may require many diagnostic procedures, including possibly more invasive tests. Also, patients need to be helped in keeping and/or increasing their confidence in such diagnostic tests, as reliable instruments for giving correct results — especially when these results are used in making major medical decisions (see also [23]). Healthcare professionals have to deal also with patients' expectations about an innovative treatment, perhaps hyped by the media or the Internet and therefore perceived as of higher quality than traditional treatments. The results of diagnostic omic tests may also indicate that a particular patient is not eligible for a given treatment. This possibility has to be explained to patients at the earliest moment, certainly pretesting. There is thus a danger of patients feeling discriminated against because their genetic makeup is “not right”, and this might lead to a fracture in the communication between patient and health professionals, and subsequent disengagement. It is therefore important to continuously assist patients in understanding clearly the background of any decision made on their treatment. Given that it is the responsibility of health professionals to speak to patients in an easily understandable language, several strategies have been proven to be effective in improving the comprehension of medical terms (for a review: [24]; see also [25]), such as well designed written information used as an adjunct to professional consultation [26]; websites [27]; and targeted mass media campaigns [28]. In particular, the provision of written and electronic information has a beneficial effect on patients' knowledge and understanding of their condition [7], and may help to increase patients' sense of empowerment, and their ability to cope with their illness [29]. However, the effect of printed and electronic material is greater when such information is personalised and reinforced by verbal information from clinicians [4]. A key point in the information exchange between health professionals and patients regards the likelihood of benefit and the risk of harm of a given treatment [30]. The optimum methods for expressing such information have not yet been determined but it appears that information on side effects in numerical form, rather than verbal descriptors, results in a more accurate estimation [16]. There is much less certainty about the presentation of benefit information, with some evidence that, on the contrary, numerical presentation may hinder comprehension due to frequent misunderstanding [31]. In general terms, it seems that the best strategy to communicate risks is ultimately a multifaceted approach that describes both the unwanted outcome and the frequency of that outcome using a combination of techniques, such as qualitative terms, numerical expression, examples from everyday life, and maybe some visual aids such as graphs or booklets (some guidelines to create well designed booklets may be found in [32]). The healthcare professional may select which format is most helpful for a given patient, and build the discussion around that [30]. Such a strategy accommodates patients with different preferences and abilities for understanding risk information. Health professionals should also be aware that information overload may be negative, in that patients try to reduce the cognitive effort required to process all the information by oversimplifying complex situations (for instance not appreciating that both high risk and high benefit coexist: [33]). As a consequence, information overload, or unwanted details, could diminish the logical consistency of patients' thoughts, and even drive patients away from engagement and from participating in decisions [34]. A final point is that the role and degree of patient's preferred involvement in care decisions, as well as the amount of desired information, may vary individually, depending on psychological, cognitive, social and cultural characteristics of each individual patient, as well as upon the characteristics of the healthcare professional–patient relationship [35]. Nonetheless, several studies succeed in identifying the most common information needs: for instance, a review on information needs among cancer patients [36] identified the following 10 categories
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(each divided into several sub-categories): cancer-specific information, treatment-related information, prognosis information, rehabilitation information, surveillance and health information, coping information, interpersonal information, financial/legal information, medical system information, and body image/sexuality information. Each category comprised several sub-categories: for instance, the “rehabilitation information” category comprises: self care issues or home care during recovery; nutrition during recovery; immediate post-treatment follow-up care; long-term side effects of cancer or treatment; recognizing or preventing complications following treatment; recovery time; and where to get medical supplies or medical equipment. However, whilst this is a comprehensive panorama of possible needs, each patient has his/her personal configuration that makes some of these needs more urgent and others almost irrelevant. Indeed, several studies have shown a substantial variation among patients about the ideal amount of information, the type of information that is considered relevant and therefore important, and the purpose of the information [37]. Also, variations in both preferred and actual participation in the care process have been reported (for a review, see [38]); several studies have attempted to determine which factors are associated with a high or low level of desired participation in the decision process: many have shown that higher education level, female sex, and age younger than 45 years are associated with patients' preference for a more active role (for a review, see [39]). In reviewing studies that examined values and preferences of patients considering antithrombotic therapy, MacLean and colleagues [40] found a significant variability in elicited patients' values and preferences regarding both prophylaxis and treatment; however, they also found that some studies' design features (such as the methods used to relay information about risks and benefits of a given treatment), and participant characteristics (such as age, sex, and living situation) may have affected participants' treatment preferences and health status evaluations. 5. Conclusion: recommendations To achieve optimal patient management, personalised medicine requires higher levels of health literacy among patients and the wider population, as well as readiness — and skills — among healthcare professionals to engage more closely with patients over treatment issues and options. Much can be done to promote health literacy among the general population, for instance by public health campaigns, as well as specific campaigns to broaden awareness of personalised medicine. However, much has also to be done by health professionals to widen the health literacy of each patient they interact with, and to encourage them to use it. In this paper, we reviewed the most relevant and shared findings and recommendations to better achieve these aims. At first, physicians should assess patients' health literacy and their knowledge and beliefs about their medical condition, by explicitly asking them what they know about their illness, and what they think about it (that is, for instance, whether they have an idea of the possible causes, or whether they have an idea of the possible therapies). Such issues are also relevant to improve adherence: the more the patient is persuaded about the therapy the more she or he will be committed to it, and the more her/his ideas about the possible causes are correct, the more she/he will be able to avoid such factors in the future (when applicable). Furthermore, the physician should tailor her/his language to the patient's health literacy level, thus improving the patients' comprehension and memory of his/her condition. As a second step, it is necessary to constantly monitor the interaction, evaluating its effect on the patient's comprehension. For instance, does the patient understand what the physician said? Are there any blind spots? The best technique to assess the patient's comprehension (probably to be restricted to doubtful interactions because it is timeconsuming) is to ask the patient to repeat what she/he understood of the information received.
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Finally, as it is important to assess patients' personal configuration of information preferences and needs, and the scope it serves, health professionals should provide patients with room for reflection and for question asking; when this is not enough, physicians may explicitly ask the patient whether she/he wishes to discuss a specific topic. For instance, in a study by Elwyn and colleagues [41] that proposes a set of steps that would enable clinical practitioners (generalists) to appropriately involve patients in decision making, general practitioners found sentences as: “There are several treatments that we could use here and I'll run through them and see which one suits you best” particularly effective to make patient aware that they have the opportunity to participate in the decision making process. Conflict of interest The authors state that they have no conflicts of interest. References [1] Coulter A. What do patients and the public want from primary care? BMJ 2005;331(7526):1199–201. [2] Coulter A. Engaging patients in healthcare. McGraw-Hill Education: New York, NY; 2011. [3] Coulter A. Patient engagement — what works? J Ambul Care Manage 2012;35(2):80–9. [4] Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev 2008;2:2. [5] Keating NL, Green DC, Kao AC, Gazmararian JA, Wu VY, Cleary PD. How are patients' specific ambulatory care experiences related to trust, satisfaction, and considering changing physicians? J Gen Intern Med 2002;17(1):29–39. [6] Gorini A, Pravettoni G. P5 medicine: a plus for a personalized approach to oncology. Nat Rev Clin Oncol 2011;8(7):444. [7] Stacey D, Bennett LL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2011;5(10):CD001431. [8] Kickbusch I, Maag D. Health literacy. In: Kris H, Stella Q, editors. International encyclopedia of public health, vol.3. San Diego: Academic Press; 2008. p. 204–11. [9] Sorensen K, Van Den Broucke S, Brand H, Fullam J, Doyle G, Pelikan, et al. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health 2012;12:80. [10] Institute of Medicine. Health Literacy: a prescription to end confusion. Washinghton DC: National Academic Press; 2004. [11] Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Viera A, Crotty K, et al. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med 2011;155(2):97–107. [12] Kessels RP. Patient's memory for medical information. J R Soc Med 2003;96:219–22. [13] HLS-EU Consortium. Comparative report of health literacy in eight EU member states. The European Health Literacy Survey (HLS-EU). Maastricht: HLS-EU Consortium; 2012 [Online publication: http://www.health-literacy.eu]. [14] Henderson S. Power imbalance between nurses and patients: a potential inhibitor of partnership in care. J Clin Nurs 2003;12(4):501–8. [15] Alston C, Paget L, Halvorson G, Novelli B, Guest J, Mccabe P, et al. Communicating with patients on health care evidence. Discussion Paper. Washington, DC: Institute of Medicine; 2012 [http://www. iom. edu/evidence. 27 Code of Federal Regulations, Protection of human subjects, title 45, sec. 46]. [16] Raynor DK, Blenkinsopp A, Knapp P, Grime J, Nicolson DJ, Pollock K, et al. A systematic review of quantitative and qualitative research on the role and effectiveness of written information about medicines. HTA 2007;11:1–177.
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