Guidelines and Guiding Principles: Perspectives from the National Diabetes Education Program (NDEP), Veterans Health Administration (VHA), and National Heart, Lung, and Blood Institute (NHLBI)
Welcome and Goals of the Meeting—Judith Fradkin, M.D., DMICC Chair
Dr. Judith Fradkin provided an update on the Special Statutory Funding Program for Type 1 Diabetes Research and efforts by patient advocacy groups to extend the funding, which currently is set to expire at the end of Fiscal Year 2013.  If the renewal efforts are successful, planning for utilization of the funds will be similar to the approach followed after the most recent renewal, in 2011. DMICC representatives will be contacted regarding the opportunity to propose projects for the Program. Dr. Fradkin also solicited suggestions from DMICC members for names of experts to form an evaluation panel to provide input on proposed projects and develop priorities for the use of the special funds. If the funding is renewed, the evaluation panel will meet in the spring/early summer. Dr. Beena Akolkar (NIDDK) is coordinating the planning effort.
Dr. Fradkin reminded members that the NIH and Centers for Disease Control and Prevention (CDC) are jointly responsible for the National Diabetes Education Program (NDEP). The NDEP was recommended in the 1970s by the National Diabetes Advisory Board, subsequently discussed at DMICC meetings, and implemented by NIH and CDC as a joint effort. Legal counsel for the Department of Health and Human Services has ruled that, as a consultative body, the DMICC cannot oversee projects like the NDEP. Rather, DMICC members and member agencies provide valuable input to—and support for—NDEP initiatives.
The NDEP Guiding Principles—Judith Fradkin, M.D., Director of the Division of Diabetes, Endocrinology, and Metabolism, NIDDK, NIH
The NDEP’s Guiding Principles are developed as a resource for health care professionals in the management of diabetes. Unlike guideline processes that include ratings of evidence, the NDEP Guiding Principles are a distillation of guidelines developed by other organizations. The Guiding Principles are intended to help in clinical judgment and are designed to build on areas of agreement and identify common principles where consensus exists. A task group, including representatives from organizations that have developed guidelines, was created and charged with updating the Guiding Principles. NDEP partners and federal agencies will be asked to review the draft, provide comments, and will be given the opportunity to co-brand the document after it is finalized. NDEP’s revised Guiding Principles document is expected to be released this summer.
Dr. Fradkin briefly presented the updated NDEP Guiding Principles. Principle 1 is “to identify people with undiagnosed diabetes and prediabetes,” and uses current American Diabetes Association (ADA) guidelines for diagnosis of diabetes and prediabetes. The NDEP language notes that risk is a continuum, and addresses considerations regarding when and how often to test an individual within various risk categories. Principle 2, “to manage prediabetes to prevent or delay the onset of type 2 diabetes,” can be accomplished through lifestyle changes or the use of metformin, as demonstrated by NIDDK’s Diabetes Prevention Program. The language highlights the importance of weight loss, and emphasizes that people with prediabetes might be at increased risk for cardiovascular disease (CVD). Principle 3 is “to provide ongoing self-management education and support for people with or at risk for diabetes.” The Guiding Principles underline key elements of self-management, including tips for providers on how to provide support and referrals to diabetes educators. Principle 4 is “to provide individualized nutrition therapy for people with or at risk for diabetes.” The focus of this principle is on individualizing and incorporating patient preferences into recommendations, and emphasizing behaviors such as portion control and consuming healthier versions of foods. Principle 5, “to encourage regular physical activity for people with or at risk for diabetes,” reviews benefits of regular physical activity, recommendations for minimum amounts of physical activity, considerations for individuals with arthritis and other physical limitations, and goal setting with patients.
Principle 6, “To control blood glucose to prevent or delay the onset of diabetes complications and avert symptoms of hyperglycemia,” focuses on factors for providers to consider when individualizing blood glucose control goals, such as age, duration of disease, and comorbidities. The document also provides a link to materials that describe the risks and benefits of various medications, and discusses current data limitations of studies of bariatric surgery. Principle 7, “to provide blood pressure and cholesterol control, tobacco cessation, and other therapies to reduce CVD risk,” suggests movement toward the use of moderate-potency statins instead of targeting a particular low-density lipoprotein goal, and includes discussion of multiple risk factor reduction. Principle 8, “to detect and monitor diabetes microvascular complications to slow the progression of the disease,” addresses assessment and management of complications and refers to specific guidelines developed by subspecialty groups. Principle 9, “to provide patient-centered care,” provides a discussion of the myriad comorbid conditions that exist in individuals with diabetes. Principle 10 is “to address the needs of special populations”—children and adolescents, women of childbearing age, older adults, and high-risk racial and ethnic groups. The language in this principle provides an overview of issues specific to each of these special populations.
Update on VHA Guidelines and Performance for Diabetes, Blood Pressure, and Lipids—Leonard Pogach, M.D., M.B.A., F.A.C.P., VHA
Dr. Pogach noted that VHA guidelines (http://www.healthquality.va.gov/Diabetes_Mellitus.asp) are shared with DoD, but differ from those of other organizations. The VHA recommends that given issues of the precision and accuracy of the A1c test in clinical practice, and issues of age and ethnicity discussed at the March 11, 2011 DMICC meeting, an A1c test between 6.5 and 7 percent needs to be confirmed with a fasting blood glucose test. The VA-DoD guidelines, since 1997 (revised 2000, 2003, 2010) have always recommended a risk-stratified approach based upon life expectancy, comorbid status, and side effects of medications, especially hypoglycemia. For example, if A1c targets can be achieved easily and the patient has a longer life expectancy, an A1c threshold less than 7 percent may be appropriate; 7 to 8 percent A1c may be appropriate for diabetes of longer duration or comorbid conditions; and 8 to 9 percent A1c may be appropriate for those with advanced microvascular complications and other major comorbidities or a life expectancy less than 5 years. Due to the variability of the A1c test a range is appropriate. Dr. Pogach noted that shared decision making between providers and patients has always been an emphasis of the VA-DoD Guidelines.
The VHA’s patient-centered performance measurement procedure targets patients most likely to benefit, helps providers to give appropriate guidance, is driven by tools that guide informed decisions, and explicitly integrates patient goals and preferences. As an example, the VHA performance measure for lipid management enables the measure to be met if patients with diabetes or ischemic heart disease are on moderate dose statins, or if their low density lipoprotein (LDL) is below 100 mg/dL. This change was based on a recent analysis of cardiovascular prevention studies that raised concerns about performance measures for lipid management based solely on achieving target values of LDL.
Dr. Pogach also highlighted the current VHA blood pressure performance measure, which utilizes a clinical action measure. This measure can be met if the achieved systolic BP is <140 mm Hg or if there is appropriate clinical action within 90 days; that is, if within 90 days, pressure has fallen below 140/90, or medication dosage has increased, or a new medicine has been added. Additionally, the measure can be met if the systolic pressure is less than 150 and the diastolic pressure is <65 mmHg, or if the patient is already on at least 3 moderate dose antihypertensive drugs.
Dr. Pogach noted that from his perspective measures promoted by other organizations may result in providers over-treating patients, which could result in potential harms. To illustrate this point, he presented a VHA study of glycemic management in older individuals. It evaluated 286,000 patients treated with oral hypoglycemic agents and/or insulin in 2009 who were over 70, had a serum creatinine over 1.7 mg/dl and/or had a coded diagnosis of cognitive impairment or dementia. Nearly half of the patients had been treated to an A1c of less than 7 percent and over one-fourth were under 6.5 percent, indicating potential overtreatment These results suggest the need for new approaches to performance measurement, such as clinical action measures or a patient safety measure. Treating each patient based upon clinical indications and shared decision making, rather than an arbitrary A1c value, is key to patient safety especially in the elderly population.
Cardiovascular Disease Prevention Guidelines and the National Program to Reduce Cardiovascular Disease Risk—Denise Simons-Morton, M.D., Ph.D., NHLBI
Dr. Simons-Morton noted that the NHLBI has partnered with organizations to move science from research studies into practice and thus improve public health by developing and disseminating evidence-based guidelines, messages, and tools. She described NHLBI’s efforts in sponsoring updates of CVD prevention guidelines in five key areas: blood pressure, cholesterol, obesity, lifestyle, and risk assessment. Expert panels developed “critical questions” for each of these subject areas, and identified criteria for determining what types of studies should be utilized for answering those questions in a systematic review. Contractors completed those reviews by performing literature searches, identified qualifying studies, and evaluating evidence quality. Graded evidence statements were developed by the expert panels and used to generate draft recommendations for practice. As the expert panels, working in parallel, complete this process, the drafts are then reviewed by federal and external experts, the NHLBI Advisory Council, the public, and HHS, to develop rigorous and integrated recommendations.
The three expert panels conducting this work (one each for blood pressure, cholesterol, and obesity) and two cross-cutting work groups (on lifestyle and risk assessment), involve more than 70 experts who are exploring a total of 16 critical questions. Importantly, these questions are not being addressed as though the answers are uniform across the population, but rather considered in view of the unique needs of multiple subgroups, such as elderly populations, racial and ethnic subgroups, and people with diabetes. In reviewing the scientific studies, experts searched for strong evidence of causality to identify associations of risk factors and CVD. Therefore, the systematic reviews for blood pressure and cholesterol considered data only from randomized clinical trials; however, the other topics included data from high-quality observational epidemiological studies because not all the key questions have been addressed through randomized trials.
Among the critical questions investigated are: LDL goals for primary and secondary prevention, as well as the impact of specific lipid management drugs; optimal thresholds to initiate antihypertensive drug treatment, goals for such treatment, and the comparative benefits and harms of specific medications; the effects of weight loss on health outcomes; associations between body mass index, waist circumference, and CVD; effects of diet and lifestyle intervention programs on weight loss or maintenance; effects of bariatric surgery; effects of dietary patterns (macro- and micronutrient composition) and physical activity on blood pressure, cholesterol, and CVD events; long-term risk prediction models for adults; assessing the effects of adding new factors to traditional risk scores; and developing a new risk equation with a CVD outcome. For the current status of the CVD guidelines, see http://www.nhlbi.nih.gov/guidelines/indevelop.htm.
Dr. Simons-Morton also presented a new, NHLBI-sponsored national educational partnership program, known as the National Program to Reduce Cardiovascular Risk (NPRCR). The NPRCR uses an integrated approach and replaces the efforts of three previous NHLBI programs (the National High Blood Pressure Education Program, the National Cholesterol Education Program, and the NHLBI Obesity Education Initiative). It will engage partners to promote use of evidence-based approaches to control or manage CVD risk factors and coordinate clinical services and community outreach. The NPRCR Coordinating Committee includes more than 30 professional organizations, federal agencies, and quality care organizations. The NPRCR is crafting a strategic plan to integrate clinical and public health approaches, and will develop common messages, materials, and tools that address the range of efforts to reduce CVD risk.
Closing Comments—Judith Fradkin, M.D., DMICC Chair
Dr. Fradkin expressed appreciation to the speakers and DMICC members for the thoughtful discussion. She noted that the DMICC meeting on gestational diabetes will be rescheduled after the NIH consensus conference, which was cancelled due to Hurricane Sandy. Dr. Fradkin pointed out that the National Institute on Aging (NIA) will hold a meeting on diabetes and CVD in the elderly, and a summary of the conference will be presented at a future DMICC meeting. Additionally, an NIDDK conference on bariatric surgery is planned for May 2013, and a DMICC meeting on bariatric surgery is planned to immediately follow. Dr. Fradkin invited suggestions of topics for future meetings from DMICC members and then adjourned the meeting. DMICC members are invited to send additional ideas for meetings to Drs. Fradkin or Roberts.
For general information about the history, goals, membership, and activities of the DMICC, please see the DMICC web page or the publication, “DMICC: Coordinating the Federal Investment in Diabetes Programs To Improve the Health of Americans.”
Dr. Fradkin, DMICC Chair, NIDDK
Dr. Pogach, VHA
Dr. Simons-Morton, NHLBI
DMICC Members Participating
Dr. Alekel, NCCAM
Dr. Atkinson, NIDCR
Dr. Avilés-Santa, NHLBI
Dr. Fradkin, DMICC Chair, NIDDK
Ms. Frant, NLM
Dr. Gao, NIAAA
Dr. Grave, NICHD
Dr. Graves, CSR
Dr. Heindel, NIEHS
Dr. Koller (for Dr. Roman), CMS
Dr. Krosnick (for Dr. Conroy), NIBIB
Dr. Pogach, VHA
Ms. Quisenberry (for Dr. Kugler), DOD
Dr. Roberts, DMICC Executive Secretary, NIDDK
Dr. Saydah (for Dr. Albright), CDC
DMICC Members Not Attending
Dr. Bartman, AHRQ
Dr. Bourcier, NIAID
Dr. Bullock, IHS
Dr. Calvo, HRSA
Dr. Chavez, NIMH
Dr. Dankwa-Mullan, NIMHD
Dr. Dutta, NIA
Dr. Eberhardt, CDC
Dr. Graham, HHS OMH
Dr. Gwinn, NINDS
Dr. Khalsa, NIDA
Dr. Krasnewich, NIGMS
Dr. Kugler, DOD
Dr. Li, NHGRI
Dr. Parks, FDA
Dr. Penn, NINDS
Dr. Peyman, NIAID
Dr. Post, USDA
Dr. Rosenblum, NCATS
Dr. Shen, NEI
Dr. Siegel, NLM
Dr. Srinivasan, HHS
Dr. Valdez, IHS
Dr. Wasserman, NINR
Dr. Wong, NIDCD
Dr. Wu, HRSA
Update: Both the Special Statutory Funding Program for Type 1 Diabetes Research and the Special Diabetes Program for Indians were renewed in January 2013 at 150 million for 1 year.