Patient participation in the clinical encounter and clinical practice guidelines: The case of patients’ participation in a GRADEd world
Introduction
It is recognized, and strongly recommended, that clinicians include the patient perspective (e.g. her values, her preferences) when making decisions about how her care will be managed, which can be facilitated through her participation in the decision about her care during the medical encounter, if she wishes. The recognition of this importance is reflected in the growth over the past half century of the person centred care (e.g. Miles & Mezzich, 2011) and shared decision making (SDM) movements (e.g. Szasz & Hollender, 1956; Brody, 1980; Quill, 1983; Charles et al., 1997 and 1999), and also in the evidence based medicine models of practice since the mid-1990s (e.g., Charles et al., 2011). 1 Likewise, patient participation (in particular, informed consent on the basis of the ethical principle of autonomy and respect for individual choice) has become a bioethical norm, and in some cases a legal obligation (Etchells et al., 1996; Arras, 2016).
The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework (GRADE Working Group, 2004) is a widely used method for developing clinical recommendations and clinical practice guidelines (CPGs).2 Developed by members of the EBM movement, GRADE explicitly includes (“typical”) patient “values and preferences” as a component of what is required to determine a recommendation regarding how to manage the care of a patient. The framework also provides instruction, contingent on the “strength” of the recommendation, as to when and how patients should participate in the clinical encounter, and thus whether an individual patient's values and preferences will be heard in her clinical encounter. However, use of GRADE derived recommendations, and specifically adherence to the instruction in the framework on how to engage the patient when making management of care decisions, is problematic to patient participation in the individual clinical encounter and may result in care that is not respectful of the individual patient's values and preferences. At the root of the problem is the conception of “values and preferences” in GRADE, which is both vague and not necessarily reflective of (or responsive to) the individual patient. The determination of recommendations in GRADE is based on population thinking (e.g. “typical” patient “values and preferences”), despite the fact that “values and preferences” are individual in the sense that they are deeply personal. Furthermore, the idea that patient participation or consideration of an individual's “values and preferences” (however defined), i.e. the model of decision making, should differ according to the strength of a recommendation constrains patient participation and is not justified (theoretically and/or empirically) in the GRADE literature. We will discuss each of these issues in this paper.
The GRADE framework has been criticized for its (lack of) theoretical and empirical basis (Mercuri and Gafni, 2018a, Mercuri and Gafni, 2018b, Mercuri and Gafni, 2018c). What impact that lack of theoretical and empirical basis might have on patient care (e.g. patient participation) guided by CPGs developed using GRADE has not been examined. Hence the examination we offer here. One important assumption that underlies our examination is that, in advocating for patient participation in the clinical encounter and in the decision about the type of care she will receive, no universally accepted right or wrong decision exists for an individual patient. We assume that the decision on how to manage the individual patient's care should be informed, but once it is informed there is no one solution for everyone – it depends on other factors (e.g., the patient's values and preferences, her specific circumstance, etc.) and not just evidence from clinical trials.
Section snippets
Clinical practice guidelines, the individual patient, and GRADE
In the background of the rise of both the EBM and patient participation movements was the proliferation of clinical practice guidelines (CPGs).3 The Institute of Medicine (2011) defines CPGs as “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and assessment of the benefits and harms of alternative care options” (p.4). CPGs and associated recommendations are general
The definition and measurement of “values and preferences” in the GRADE framework
Patient “values and preferences” is identified in the GRADE literature as an important factor in determining a recommendation and its strength. Likewise, within the GRADE literature, patient “values and preferences” are discussed in the context of applying the recommendation in the clinical encounter (i.e., the type of decision making model recommended for the encounter – paternalistic or shared decision making). Information about how potential outcomes (and the likelihood they obtain) stemming
Patient participation in decision making following the GRADE framework
Several models of clinical decision making have been described in the literature. Each model incorporates an approach to patient participation during the clinical encounter. The most commonly discussed models in the healthcare literature are paternalism, informed decision making, and SDM. The models describe who participates in information sharing, deliberation, and decision making, including what kind of information is shared (e.g. medical, values and preferences) and how (e.g. from clinician
Implications of the GRADE framework on patient participant and clinical decision making
Within the GRADE framework, the strength of a recommendation directs the clinician (and patient) on the extent and content of patient participation in the clinical encounter. However, as we have shown, there is no theoretical basis for why a “strong” recommendation entails paternalism (or in some cases, SDM, although when is not clear) and a “weak” recommendation, SDM (suggestions of when paternalism should be used and when SDM should be used is paternalistic, perhaps ironically). Furthermore,
Conclusions
The problems we raise in this paper will not, in our opinion, be solved by simply revising the definitions of “strong” and “weak” recommendations and/or untying the model of decision making from the strength of recommendation. The problems stem from a lack of a valid theoretical and/or empirical basis for the GRADE framework. The framework seems to favour “average effects” – i.e. populations. For example, estimates of therapeutic effect are based on “average” effects derived from systematic
CRediT authorship contribution statement
Mathew Mercuri: Conceptualization, Investigation, Writing - original draft, preparation, Writing - review & editing. Brian S. Baigrie: Conceptualization, Writing - review & editing. Amiram Gafni: Conceptualization, Writing - review & editing.
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