Defining the meaning, role, and measurement of “values and preferences” in the development of practice guidelines: The case of GRADE

Both the Evidence Based Medicine (EBM) and Person Centered Healthcare (PCH) movements recognize that decisions on how to manage the care of individual patients in the clinical encounter require more than simple application of those therapies shown effective in a clinical trial.  GRADE, a popular framework for developing clinical recommendations, identifies patient “values and preferences” as an important consideration in clinical decision making and a component in determining a clinical recommendation and its strength. However, how patient “values and preferences” are conceptualized in GRADE are problematic if one believes the individual patient’s care should be aligned with her values and preferences. GRADE focuses on “typical” patient “values and preferences” in the process of determining the recommendation. There is no guarantee that the values and preferences of the typical patient will represent that of the individual patient in the clinical encounter. Furthermore, the strength of the recommendation (“strong” vs . “weak”) appears to impact how much patient engagement is warranted (under GRADE), which affects the extent to which information on the “values and preferences” of the individual patient will be sought out or revealed in the clinical encounter. The issues raised in this paper stem from a lack of an underlying theory and empirical support to explain why certain elements have been included in the framework, and others not. A failure to clearly define, operationalize, and measure a patient’s “values and preferences” may limit the value of GRADE derived recommendations and subsequent clinical practice guidelines in managing the care of individual patients consistent with PCH.