Patient participation in the clinical encounter and clinical practice guidelines: The case of patients’ participation in a GRADEd world

Highlights

• Shows GRADE focus on typical patient values and preferences is problematic.

• Explains the lack of theoretical and/or empirical support for the GRADE approach.

• Shows that how to operationalize GRADE suggestions is not clear.

• Highlights a lack of justification for only two modalities of decision-making in the encounter.

Abstract

It is widely acknowledged that the patient's perspective should be considered when making decisions about how her care will be managed. Patient participation in the decision making process may play an important role in bringing to light and incorporating her perspective. The GRADE framework is touted as an evidence-based process for determining recommendations for clinical practice; i.e. determining how care ought to be managed. GRADE recommendations are categorized as “strong” or “weak” based on several factors, including the “values and preferences” of a “typical” patient. The strength of the recommendation also provides instruction to the clinician about 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. That is, a “strong” recommendation encourages “paternalism” and a “weak” recommendation encourages shared decision making. We argue that adoption of the GRADE framework is problematic to patient participation and may result in care that is not respectful of the individual patient's values and preferences. We argue that the root of the problem is the conception of “values and preferences” in GRADE – the framework favours 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. We also show that tying the strength of a recommendation to a model of decision making (paternalism or shared decision making) constrains patient participation and is not justified (theoretically and/or empirically) in the GRADE literature.

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.