Inclusion of Hypoglycemia in Clinical Practice Guidelines and Performance Measures in the Care of Patients With Diabetes
Rene Rodriguez-Gutierrez, MD, MSc, Naykky Singh Ospina, MD, MSc, Rozalina G. McCoy, MD, MS, Kasia J. Lipska, MD, Nilay D. Shah, PhD, Victor M. Montori, MD, MSc, and for the Hypoglycemia as a Quality Measure in Diabetes Study Group
Health care organizations use publicly reported performance measures for quality measurement and improvement and pay-for-performance initiatives.1 These measures should ideally promote high-quality care that is evidence based and congruent with clinical practice guidelines. However, they should also reward patient-centered care that yields optimal outcomes with the lowest risk of harm.2 For patients with both type 1 and type 2 diabetes, high-quality care should therefore minimize the risk of hypoglycemia.2 The degree to which existing performance measures are aligned with guidelines, particularly in regard to hypoglycemia avoidance, is uncertain. We therefore conducted an environmental scan to assess the inclusion and prioritization of hypoglycemia in contemporary clinical guidelines and performance measures for patients with diabetes.
A 2-step environmental scan process was used to identify contemporary guidelines and performance measures from January 1, 2010, to March 15, 2016. The terms diabetes, guidelines, and standards of care were used to identify clinical guidelines about diabetes. This search was strengthened with a search in the National Guideline Clearinghouse. Diabetes, quality, performance measures, quality-metric, and quality measure were used to identify quality measures initiatives. A comprehensive search was also performed in the National Quality Measures Clearinghouse. Chance-adjusted agreement for selection of guideline and performance measures initiatives between reviewers working independently
Author Contributions: Drs Montori and Rodriguez-Gutierrez had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Rodriguez-Gutierrez, Singh Ospina, Lipska, Montori.
Acquisition, analysis, or interpretation of data: Rodriguez-Gutierrez, Singh Ospina, McCoy, Montori.
Drafting of the manuscript: Rodriguez-Gutierrez.
Critical revision of the manuscript for important intellectual content: Rodriguez-Gutierrez, Singh Ospina, McCoy, Lipska, Montori. Statistical analysis: Singh Ospina.
Obtaining funding: Rodriguez-Gutierrez.
Administrative, technical, or material support: Rodriguez-Gutierrez, Singh Ospina, Montori.
Study supervision: Rodriguez-Gutierrez.
Conflict of Interest Disclosures: Dr Lipska reported receiving support from the Centers for Medicare & Medicaid Services to develop and maintain publicly reported quality measures. No other disclosures were reported.
Group Members: The members of the Hypoglycemia as a Quality Measure in Diabetes Study Group are as follows: Yogish C. Kudva, MBBS, Kasia J. Lipska, MD, Rozalina G. McCoy, MD, MS, Victor M. Montori, MD, MSc, Rene Rodriguez-Gutierrez, MD, MSc, Nilay D. Shah, PhD, Naykky Singh Ospina, MD, MSc, and Henry H. Ting, MD, MBA.
Additional Contributions: Patricia Erwin, MLS, expert librarian from the Mayo Clinic, provided valuable assistance with the search strategy. She was not financially compensated for this service.
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was excellent (κ = 0.83 and κ = 0.91, respectively). Disagreements were resolved by consensus. Eligible guidelines and performance measures were the latest published full-text versions of systematically developed statements produced under the auspices of medical specialty or professional associations or public or private organizations at a federal, state, or local level. Neither institutional review board approval nor patient consent was required.
We identified 18 diabetes practice guidelines and 23 performance measures initiatives. All practice guidelines advocated for hypoglycemia ascertainment and treatment, although supported by evidence at varying risk of bias (Table 1). However, only 2 organizations, the National Institute of Health Excellence and the National Information Diabetes Service in the United Kingdom, had issued corresponding performance measures that addressed hypoglycemia. These measures addressed severe not mild hypoglycemia (Table 2), defined as hypoglycemic events that required assistance of others for treatment. The remaining 21 performance measures did not address hypoglycemia ascertainment, treatment, or prevention. In contrast, 80% to 90% of diabetes care performance measure initiatives included multiple surrogate outcome or process measures, such as hemoglobin A1c measurement and target level; low-density lipoprotein cholesterol target level; blood pressure control; nephropathy, retinopathy, and neuropathy screening; smoking cessation; and aspirin use for patients with atherosclerotic cardiovascular disease.
The goals of diabetes care are to increase the patients’ longevity, decrease the risk of acute and chronic complications, and increase the health-related quality of life. Considering the substantial morbidity, associated mortality, and decreased quality of life caused by hypoglycemia,3–6 its prevention is an integral part of patient-centered diabetes care along with hemoglobin A1c control, as reinforced by clinical practice guidelines. However, it remains surprising that less than 10% of the initiatives included a corresponding hypoglycemia performance measure. Efforts are under way to develop reliable, measurable, actionable, and meaningful hypoglycemia measures. These measures may include documentation of hypoglycemic events at each visit, hypoglycemia awareness and management education programs, prescription and patient use of diabetes medical alerts, or prescriptions of glucagon and/or glucose tablets. Engagement of patients to identify and address precipitating causes of hypoglycemia, including treatment regimen change, can also be recorded. When carefully constructed and implemented, a hypoglycemia-focused performance measure would serve as a counterbalance for the current measures. It would be a paradigm shift in the care for patients with diabetes because it would facilitate a holistic approach that prioritizes not only efficacy but also safety and patient-centeredness of diabetes care.