The overall methodological quality of the guidelines was low (using the AGREE II instrument, with mean overall score of 56%, SD=23%) (Supplemental Digital Content 2, http://links.lww.com/MLR/A559 for item and subscale scores). Thirteen (46%) guidelines did not report on the process used to generate recommendations. Patients or methodologists were not explicitly included in the guideline development process in 20 (71%) and 24 (86%) guidelines, respectively.
Guidelines most frequently offered recommendations about treatment goals: about glycemic control targets in 27 (96%) and about LDL-cholesterol targets in 20 (71%) guidelines. Fewer guidelines made recommendations taking into context the overall burden of treatment; for instance, 16 (57%) made recommendations about healthcare visit frequency (Table 1).
Most diabetes guidelines are lacking in the extent to which they explicitly take into account the context of patients with MCC. When patient context was considered in guidelines, it was often in the form of “blanket statements” in the Introduction section, instructing clinicians to apply the guidelines with consideration of individual patient context but offering no specific guidance on how to prioritize tasks that compete for patients’ time, effort, and attention. Although incorporation of patient context was poor overall, guidelines tended to take into account medical comorbidities to a greater extent than socio-personal context or personal preference. When they did this, however, they considered these comorbidities biologically (ie, as a source of physiological interactions) rather than in terms of cumulative complexity or target patient-centered outcomes. When recommendations were categorized on the basis of whether they represented treatment goals or treatment burden, neither category of recommendation appeared to address patient context more than the other.
The main limitations of this work are that we used a rubric with only face validity to ascertain context and that we did not contact the guideline authors to uncover implicit considerations of context. The main strengths of our work include the reproducibility of our guideline inclusion, assessment of guideline quality and contextualization, use of a reproducible rubric, and the selection of contemporary guidelines in one of the chronic conditions receiving most quality-of-care attention. The rubric used here might be adaptable to other chronic conditions by substituting the condition-specific recommendations with ones pertinent to other conditions at hand (in terms of treatment goals and treatment burden) and scoring guidelines according to whether their recommendations take into account patient context (ie, comorbidities, socio-personal context, and patient preferences).
To our knowledge, this is among the first studies to systematically evaluate the extent to which diabetes management guidelines take into account patient context and consider how MCC might affect recommendations for patients with a common comorbidity. Many have commented, however, about the need to contextualize recommendations among patients with MCC.54–58 A recent review of Canadian clinical practice guidelines for high-prevalence conditions, including diabetes, hypertension, and dyslipidemia, found that comorbidities, barriers to implementation, and patient context such as life expectancy were given adequate consideration by only a minority of guidelines. Consistent with our findings, when recommendations were made in the guidelines, they were vague and nonspecific.54
One proposed explanation for the paucity of consideration given to patient context in guideline recommendations is that there might be an insufficient body of evidence to inform modification of single-disease recommendations when considering patients with complex contexts, such as patients with MCC. Clinical trials often exclude or underrepresent patients with certain comorbid conditions, and subgroup analyses are rarely conducted against socio-personal features. The role of personal preferences—particularly when competing priorities exist—also remains poorly studied. This might be limiting the ability of guideline developers to reach evidence-based conclusions that address these aspects of care.56,58 Tinetti et al6 have proposed a focus on patient-important outcomes as a way of harmonizing recommendations for patients with MCC; however, the most common recommendations in guidelines we reviewed have poor connection with such outcomes (ie, lowering HbA1c is not uniformly associated with improvements in functional capacity or symptom burden). Weak or tentative guideline recommendations take place when the trade-offs are unclear or when the pros and cons of alternative courses of action are closely matched. In these instances it is optimal to engage patients in the decision-making process. When guideline panels fail to detect these situations, they might instead frame them as technical “just do it” dictums that are often used to inform quality-of-care parameters and leave little room for patient involvement.56,58 This naturally leads to a tendency to “overtreat” or “treat to numbers,” which might cause more harm than good.56,58 A recent editorial has provided an extended example of how recommendations to achieve “tight” glycemic control might need to be modified to account for comorbidities, socio-personal context, and patient preferences.59
The GRADE approach emphasizes the need to devote more effort to shared decision making when recommendations are weak, in order to ensure that the choice made reflects the patient’s values and preferences.60 However, even in the context of strong recommendations, GRADE highlights a need to frame recommendations in the context of different values and preferences, which may lead to opposite courses of action based on the same evidence when various outcomes are weighed differently.60 In this vein, it may be helpful to include in specific recommendations an explicit statement of the preferred outcome judgments that the recommendation was based on.60 Another way this can be achieved in the framework of current guidelines is to make recommendations along with reasons why a patient may choose to deviate from the recommended course.60 It is clear, however, on the basis of our review, that these principles from the GRADE approach have not fully penetrated the realm of diabetes guidelines.
Other specific approaches to improve clinical practice guidelines by incorporating patient context and comorbidities have been proposed. For example, van Weel and Schellevis57 propose categorizing comorbidities as causal (diseases sharing a common pathophysiology), complicating (those that are disease specific), intercurrent (acute, interacting illnesses), and concurrent (no specific relation) in order to identify focus areas and separate comorbidities by the approach required to address them. Piette and Kerr61 offer a similar classification of comorbidities for people with diabetes as being dominant, concordant, discordant, symptomatic, and asymptomatic. Dominant comorbidities are those that command so much attention that they overshadow diabetes (eg, cancer, cognitive impairment). Concordant comorbidities (similar to those classified by van Weel and Schellevis as “causal”) share the same pathophysiology as diabetes and fit in the management plan for diabetes (eg, hypertension, peripheral vascular disease). In contrast, discordant comorbidities (similar to those referred to as “concurrent” by van Weel and Schellevis) are unrelated to diabetes in their pathophysiology or management (eg, chronic back pain, asthma). With symptomatic comorbidities (eg, depression, gastroesophageal reflux disease), the main focus is on symptom management and quality of life, although limited attention may be given to prevention of long-term complications. In contrast, the focus on asymptomatic comorbidities (eg, hypertension, hyperlipidemia) is solely on preventing long-term complications.61
Calculating and reporting a “payoff time” for guideline recommendations, over which a patient must comply with the guideline so as to achieve the proposed benefit, has also been proposed in order to help patients weigh guideline compliance with their comorbidities and personal context.55 As an example, a patient with limited life expectancy having difficulty maintaining tight glycemic control on oral antihyperglycemic pharmacotherapy should balance the payoff time for tight glycemic control with insulin to prevent long-term complications of diabetes with the burden and cost of regular blood glucose monitoring, risk of hypoglycemia, and the cost of the insulin regimen required. If the payoff time is greater than the patient’s life expectancy, a discussion in the context of shared decision making about foregoing insulin therapy may lead to a decreased burden of treatment with a corresponding increase in quality of life, improved cost-benefit, and more patient-centered care.
Although some have suggested the development of guidelines focused on specific population subsets (eg, patients with a disease plus specific comorbidities), it is unrealistic to develop guidelines that cover every possible permutation of patient circumstances, especially in the case of multimorbidity and preference-sensitive decisions.57 Instead, clinical practice guidelines must take a holistic approach, which provides practical guidance clinicians can use to individualize care while focusing on patient-important rather than disease-centered outcomes.6,57 Individualization of care to incorporate patient context and preferences necessitates patient participation in decision making. Guidelines should offer tentative recommendations when these might apply to patients with MCC, opening the space for conversations with patients and shared decision making.62,63 In the absence of these enlightened approaches, high-fidelity adherence to current guidelines results in an overwhelming number of clinical actions and an absurd accumulation of work and complexity to which clinicians and patients can only respond with noncompliance.
Although algorithmic guidelines are relatively simple to implement, individualized care is less straightforward, as there is little guidance to help clinicians individualize care.64 Although there is limited evidence in the literature on ways to improve outcomes for patients with complex contexts, including MCC,13 we urge those developing guidelines for chronic conditions to consider patient context in every recommendation they make and to offer specific modifications (in action, timing, or intensity) based on comorbidities, socio-personal context, and patient preferences.
Extant clinical practice guidelines for one chronic disease sometimes consider the context of the patient with that disease but do so narrowly and infrequently. Guideline panels must remove their contextual blinders if they want to practically guide the care of patients with MCC.
The authors thank Larry Prokop at the Mayo Clinic Libraries for assistance in conducting the literature search. The authors also acknowledge Hannah Fields for her contribution to the screening process.
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