Review articlePatient autonomy in multiple sclerosis — Possible goals and assessment strategies
Introduction
In a broader definition, patient autonomy (PA) in the medical context describes patients making use of their right of self-determination when dealing with a health matter. PA refers to patients' self-perception, perceptions by others as well as behavior in the fields of information seeking and perception, care, treatment, and medical decision making. Applied to the field of medical decision making, PA in Western countries is increasingly considered necessary. In medical decisions with a need to involve a health expert PA becomes apparent in the patients' participation in communication as described in the concept of shared decision making [1].
PA has been advocated for different reasons: First, for ethical reasons it is axiomatic to put every effort in supporting individuals' freedom of will as included in the guideline of the British General Medical Council (GMC) [2]. These guidelines also claim that there is a responsibility of patients to inform themselves before decisions are made.
Second, as making best use of scientific evidence for the individual patient is only possible when patient values are considered, PA is considered an essential part of evidence based medicine (EBM) [3]. In particular, patients' preferences should guide the choice, if the evidence does not clearly imply a first choice – which is called an equipoise condition – or even regularly if more than one option is available. Third, patients' autonomous participation in their health management might improve health outcomes due to a better fit of health decisions with individual needs. In fact, the evidence in this respect is ambiguous [4].
There are also possible misconceptions. In cases difficult to decide on, PA might be misused by health professionals as a possible strategy to avoid responsibility or as an efficient strategy to achieve higher compliance/adherence of patients who are given the impression of autonomy. Also PA might give the impression of the health system as a “health shopping center”, reducing health management and patient–physician relationship to an economic interaction.
All the more, most of these aspects are also relevant to the field of medical practice, training and research in multiple sclerosis. More and more partially effective costly treatments, some of them with considerable side-effects, are available [5]. So e.g. if to continue natalizumab treatment for more than two years when JC virus antibodies in serum are positive is a highly preference sensitive decision. Furthermore, recent studies have shown adherence rates of no more than 50% for first-line treatments [6]. The example of the recent discussion on venous "liberation" and the pressure of patient groups to gain access to this procedure also show possible misconceptions of PA [7]. Do these complexities call for more rigorous patient guidance especially in a disease which affects cognition and reasoning?
To account for this situation, the debate on the need for enhanced patient participation in this kind of complex medical decisions and on appropriate strategies to support patient autonomy should be held based on more clarity regarding the question for the goals of PA. Furthermore, the goals of PA should drive its evaluation: Is PA fulfilling an ethical postulate? Should it make the health system more efficient? Or result in better health outcomes?
It is unclear whether patient autonomy in treatment decisions should necessarily lead to an improvement of other “traditional” patient-relevant outcomes (e.g. mortality, morbidity, quality of life) or if involvement is a normative necessity and therefore a patient-important outcome on its own. An ethical justification of PA would therefore imply focusing the process of decision making. The evaluative focus lies in clarifying to what extent patients' decisions have been made autonomously, or to what extent patients were involved in their medical decisions. If PA is intended to act as a strategy to reach certain outcomes, any evaluation has to relate the extent of patient participation in the decision making process to these specific outcomes such as knowledge, compliance, realistic expectations, health status, disease management competences, or quality of life. Independent of the underpinning goal, PA needs evaluation regarding its basic, prerequisites and facilitating factors.
When our work on PA in MS was started in 2001, evidence was rare for general validity of instruments assessing doctor patient communication and efficacy of patient involvement interventions. As well, relevance of PA in MS had not been the subject of systematic research. Therefore, a considerable part of our work intended to yield a better understanding of the nature of medical decisions, communication processes, context and background. Furthermore, we conducted studies, where our evaluative approaches were applied in efficacy trials of interventions supporting MS-patients' medical decision making.
This review paper provides an overview of measurement issues and achievements at three defined time-points in a decision making process as has recently been proposed by Scholl et al. [8].
First we report on attempts to capture contexts, requirements or decision prerequisites building the ground upon which decision making processes unfold. Second we provide insight into approaches focusing the process of medical decisions including both, the internal (cognitive–emotional) and the communicative elaboration of a medical decision. Third, methods are described trying to differentiate medical decisions in terms of patient involvement on the level of outcomes. Outcomes can be defined on different complexity levels most simply as the distribution of choices or more complex in terms of psychological concepts as satisfaction and regret or even health state (Table 1).
Section snippets
Prerequisites
The specific process a person unfolds when facing a (medical) decision of pronounced importance is driven by a complex interaction of the person's cognitive styles, personality traits, cognitive and social competencies with the specific disease related and environmental context. These factors contribute to shaping of individual health belief models and coping styles. While unable to yield comprehensive assessment of all or even most of the factors which seemed relevant to us as prerequisites of
Process of the decision
Depending on the point of view, the elaboration of a medical decision can be conceived either internally on a cognitive emotional level as well as interpersonally on the level of communication. Using the corresponding concepts from social and cognitive psychology and communication science, we applied both viewpoints in our evaluation of MS decision making.
Health status & utilization of health resources
As outlined above very few interventions on PA or on patient involvement have been shown to really affect patients' health status [4]. In fact, health care utilization might be another straight-forward robust outcome parameter. In our first RCT [20] we have shown that provision of comprehensive EBPI and participation in a 4-hour educational program alters patients' disease management. During two years of follow-up, patients in the intervention group had significantly fewer relapses and there
Discussion
Patient autonomy has been stressed as the ideal concept for medical decision making. MS represents an prototypical condition for this approach as the disease affects young, highly competent people on the one hand and as on the other hand treatments are only partially effective some of them with considerable side effects. In recent years we have studied prerequisites for patient autonomy in MS treatment decision making along with different interventions to modulate decision making processes.
Conclusion
In conclusion we have developed a battery of tools to analyze different steps in decision making processes in MS and other diseases in order to clarify important factors modulated through SDM and EBPI interventions. In addition these tools may help to benchmark knowledge and compare elaboration of decisions in different health care settings or different countries and cultures.
Funding
This work has been done with support of the German Ministery of Health, a Rehabliation Fellowship from the National MS Society of the US, the "Verein zur Förderung der Rehabilitationsforschung" and Merck-Serono Pharma. The AutoMS was funded by the Fondazione Italiana Sclerosi Multipla (FISM) and the Gemeinnützige Hertiestiftung.
Conflict of interest
CH has received grants from Biogen-Idec, Merck-Serono, Novartis Pharma and Teva Pharma as well as speaker's fees. AS has received a board membership fee from Novartis and speaker's fees from Sanofi-Aventis. JK has received travel expenses from Merck Serono. FG has no conflict of interest.
Acknowledgments
We thank all patients and physicians who participated in our research summarized in this review.
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