The New England Journal of Medicine

Numéro : Volume 368(17), 25 April 2013, p 1613-1624
Copyright : Copyright (C) 2013 Massachusetts Medical Society. All rights reserved.
Type de publication : [Special Article]
DOI : 10.1056/NEJMsa1213829
ISSN : 0028-4793
Accès : 00006024-201304250-00013

Achievement of Goals in U.S. Diabetes Care, 1999-2010

Ali, Mohammed K. M.B., Ch.B., M.B.A.; Bullard, Kai McKeever M.P.H., Ph.D.; Saaddine, Jinan B. M.D., M.P.H.; Cowie, Catherine C. M.P.H., Ph.D.; Imperatore, Giuseppina M.D., Ph.D.; Gregg, Edward W. Ph.D.
Informations sur l'auteur
From the Division of Diabetes Translation, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention (M.K.A., K.M.B., J.B.S., G.I., E.W.G.), and the Rollins School of Public Health, Emory University (M.K.A.), Atlanta; and the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD (C.C.C.).
Address reprint requests to Dr. Ali at the Division of Diabetes Translation, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Mailstop K10, 4770 Buford Hwy. NE, Atlanta, GA 30341, or at [email protected].
The findings and conclusions in this report are those of the authors and do not necessarily represent the official positions of the Centers for Disease Control and Prevention or the National Institutes of Health.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

ABSTRACT

BACKGROUND: Tracking national progress in diabetes care may aid in the evaluation of past efforts and identify residual gaps in care.

METHODS: We analyzed data for adults with self-reported diabetes from the National Health and Nutrition Examination Survey and the Behavioral Risk Factor Surveillance System to examine risk-factor control, preventive practices, and risk scores for coronary heart disease over the 1999-2010 period.

RESULTS: From 1999 through 2010, the weighted proportion of survey participants who met recommended goals for diabetes care increased, by 7.9 percentage points (95% confidence interval [CI], 0.8 to 15.0) for glycemic control (glycated hemoglobin level <7.0%), 9.4 percentage points (95% CI, 3.0 to 15.8) for individualized glycemic targets, 11.7 percentage points (95% CI, 5.7 to 17.7) for blood pressure (target, <130/80 mm Hg), and 20.8 percentage points (95% CI, 11.6 to 30.0) for lipid levels (target level of low-density lipoprotein [LDL] cholesterol, <100 mg per deciliter [2.6 mmol per liter]). Tobacco use did not change significantly, but the 10-year probability of coronary heart disease decreased by 2.8 to 3.7 percentage points. However, 33.4 to 48.7% of persons with diabetes still did not meet the targets for glycemic control, blood pressure, or LDL cholesterol level. Only 14.3% met the targets for all three of these measures and for tobacco use. Adherence to the recommendations for annual eye and dental examinations was unchanged, but annual lipid-level measurement and foot examination increased by 5.5 percentage points (95% CI, 1.6 to 9.4) and 6.8 percentage points (95% CI, 4.8 to 8.8), respectively. Annual vaccination for influenza and receipt of pneumococcal vaccination for participants 65 years of age or older rose by 4.5 percentage points (95% CI, 0.8 to 8.2) and 6.9 percentage points (95% CI, 3.4 to 10.4), respectively, and daily glucose monitoring increased by 12.7 percentage points (95% CI, 10.3 to 15.1).

CONCLUSIONS: Although there were improvements in risk-factor control and adherence to preventive practices from 1999 to 2010, tobacco use remained high, and almost half of U.S. adults with diabetes did not meet the recommended goals for diabetes care.



An estimated 18.8 million adults in the United States have diagnosed diabetes mellitus.1 Diabetes increases the risk of disabling and life-threatening complications from microvascular disease (affecting the kidneys, eyes, and limbs) and macrovascular disease (involving the coronary vascular, cerebrovascular, and peripheral vascular systems). Two decades ago, the Diabetes Control and Complications Trial (DCCT)2 and the United Kingdom Prospective Diabetes Study (UKPDS)3 showed that improved glycemic control is associated with reduced microvascular complications and long-term reductions (at the least) in macrovascular disease.4,5 Subsequent trials showed that lowering blood pressure, reducing cholesterol levels, and avoiding tobacco decreases the incidence of vascular diseases and mortality.6-8 Therefore, guidelines for diabetes care 9 recommend risk-factor control and regular screening for complications in order to treat conditions related to diabetes in their early stages.

Diabetes is one of the first conditions for which disease-specific indicators based on practice guidelines have been used to "score" the quality of care and preventive services.10,11 Previous studies have shown that diabetes care improved between 1988 and 2002.12 An assessment of the changes in care over the past two decades is particularly important because this period has been characterized by increased public awareness and quality-improvement initiatives and by large trials comparing alternative treatment targets for diabetes.13-17 These studies showed that there were no incremental cardiovascular benefits of aggressive control and led to a renewed emphasis on individualized glycemic targets based on age, coexisting conditions, and time since the diagnosis of diabetes.18,19 For this study, we have used national surveillance data from 1999 through 2010 to assess trends in risk-factor control and adherence to preventive practices among U.S. adults with diabetes, to evaluate care based on individualized performance measures, and to assess variation in these trends across different clinical and sociodemographic groups.

METHODS

STUDY DESIGN

We analyzed data from the National Health and Nutrition Examination Survey (NHANES) (1999 through 2002, 2003 through 2006, and 2007 through 2010) and from the Behavioral Risk Factor Surveillance System (BRFSS) survey (2000, 2004, and 2008). The NHANES uses stratified, multistage, probability-cluster techniques to ensure that sample populations are representative of the nation's noninstitutionalized civilians. Data are collected from household interviews and from standardized medical examinations and blood-sample collections performed in mobile examination centers. Response rates for the NHANES cycles between 1999 and 2010 ranged from 75.4 to 80.0%. The BRFSS is an annual state-based survey, conducted over landline telephone networks, that collects self-reported data on health-related behavior from approximately 350,000 adults. The median BRFSS response rates across the years surveyed were 48.9% in 2000, 52.7% in 2004, and 53.3% in 2008. Further details about the study design, the survey instruments, and data-collection methods are available elsewhere.20,21

This analysis included 3355 adults from the NHANES who reported having received a diagnosis of diabetes from a health professional and 97,310 adults from the BRFSS who reported having diabetes. As in previous studies,12 we evaluated the control of single or combined risk factors for microvascular and macrovascular complications of diabetes (glycemia, blood pressure, cholesterol level, and tobacco use) and adherence to preventive practices (screenings, glucose monitoring, and vaccinations). Analyzing each survey cycle independently over the study period, we benchmarked these results against a combination of performance measures from the National Quality Forum 22 and the American Diabetes Association (Table 1).9

Table 1 Table 1 Opens a popup window Opens a popup window Opens a popup window

INDICATOR and COVARIATE DEFINITIONS

We used interview responses to classify participants in terms of age, race or ethnic group, educational level, income, and insurance status. Interview responses and examination data were used to obtain data on weight, duration of diabetes, receipt of glucose-lowering treatments, and the presence of coexisting conditions. Detailed definitions of self-reported, anthropometric, and biochemical indicators are described in the Methods section in the Supplementary Appendix, available with the full text of this article at NEJM.org.

We calculated the weighted proportions of survey participants with glycemia that was poorly controlled (glycated hemoglobin level, >9.0%), moderately controlled (<8.0%), or well controlled (<7.0%), as defined by recommended standards. On the basis of recent reports,18,19,23 we also used individualized glycated hemoglobin targets according to risk profile: participants younger than 45 years of age without complications (glycated hemoglobin level, <=6.5%) or with complications (<=7.0%); those 45 to 64 years of age without complications (glycated hemoglobin level, <=7.0%) or with complications (<=8.0%); and those 65 years of age or older without complications (glycated hemoglobin level, <=7.0% or <=7.5%) or with complications (<=8.0%). The target for blood-pressure control was a level below 130/80 mm Hg, and the targets for lipid control were a low-density lipoprotein (LDL) cholesterol level of less than 100 mg per deciliter (2.6 mmol per liter), with a target of less than 70 mg per deciliter (1.8 mmol per liter) for those with preexisting cardiovascular disease.

To convey the benefits of optimizing diabetes care, at each time period, we reported the proportion of participants without microalbuminuria (albumin:creatinine ratio, <30 mg of albumin per gram of creatinine) and calculated the 10-year risk of coronary heart disease with the use of a diabetes-specific score (as calculated in the UKPDS) and a general score (as calculated in the Framingham Heart Study).24,25

Indicators that participants were adhering to preventive practices included annual measurement of lipid levels and eye, foot, and dental examinations; receipt of recommended vaccinations (annual influenza vaccination and >=1 lifetime pneumococcal vaccination, especially for patients 65 years of age or older); receipt of diabetes education at diagnosis; and monitoring of glucose levels (one or more times per day). For participants with an albumin:creatinine ratio of 30 mg of albumin per gram of creatinine or higher, another indicator was the receipt of an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB).

STATISTICAL ANALYSIS

We conducted the statistical analysis with the use of SAS software, version 9.2 (SAS Institute) and SUDAAN software, version 10.0 (Research Triangle Institute), adjusting for complex survey designs and nonresponse. Sample sizes varied according to the primary outcome analyzed. The proportion of study participants with missing data ranged from 0.2% (educational level) to 12.0% (annual measurement of lipid levels). We determined the distribution of risk factors (glycated hemoglobin level, blood pressure, LDL cholesterol level, and status with respect to tobacco use) among participants and tested for distributional differences at successive time points, using adjusted Wald F tests. We calculated the proportions of participants who met single and combined targets in two categories: risk-factor control (control of glycated hemoglobin level, blood pressure, LDL cholesterol level, and tobacco use) and adherence to recommended schedules (eye examinations, foot examinations, and influenza vaccinations). We calculated the predicted change in proportions of participants meeting targets between each period by using an interaction term for survey years in models and standardizing to the covariate distribution for the entire sample. We used nonoverlapping 95% confidence intervals as an indicator of significance and did not adjust for multiple testing because this could have led to misinterpretation of the data.26 To determine which variables were associated with changes in risk-factor control and preventive practices over time, we used logistic-regression models adjusted for age, sex, race or ethnic group, educational level, health insurance status, and use or nonuse of insulin.

RESULTS

CHANGES IN U.S. POPULATION WITH DIABETES

Among the population surveyed with diabetes, the distribution of age and sex, the proportion without health insurance, and the time since diagnosis remained fairly constant across survey years (Table 2). Increasing proportions of adult patients with diabetes identified themselves as Hispanic or Mexican American or as members of a race or ethnic group other than non-Hispanic white, non-Hispanic black, Hispanic, or Mexican American.

Table 2 Table 2 Opens a popup window Opens a popup window Opens a popup window

As compared with the population with diabetes covered in NHANES from 1999 through 2002 and in the BRFSS survey in 2000, the population covered in later surveys had larger proportions of participants reporting at least some college education and an income of $20,000 or higher. The proportion of overweight participants decreased, whereas the proportions that were obese increased, as did the proportion of participants taking medications to lower glucose levels (in the NHANES) and the proportion using insulin (in the BRFSS).

Between the 1999-2002 period and the 2007-2010 period (Table 3), the proportion of patients with poor glycemic control decreased (-5.8 percentage points; 95% confidence interval [CI], -10.5 to -1.1). There were significant increases in the proportions of participants who met the recommended targets for glycated hemoglobin level (7.9 percentage points; 95% CI, 0.8 to 15.0), blood pressure (11.7 percentage points; 95% CI, 5.7 to 17.7), and LDL cholesterol level (20.8 percentage points; 95% CI, 11.6 to 30.0). The proportion of participants using tobacco did not change significantly (-1.7 percentage points; 95% CI, -6.2 to 2.8). The population distributions of glycated hemoglobin and LDL cholesterol levels both improved significantly over time (the fraction of participants with poor control became smaller) (Figure 1). From 1999 to 2010, the mean glycated hemoglobin level decreased by 0.4 percentage points, to 7.2%; the mean LDL cholesterol level decreased by 17.7 mg per deciliter (0.5 mmol per liter), to 99.5 mg per deciliter (2.6 mmol per liter); and the mean blood pressure decreased by 4/2 mm Hg, to 130/68 mm Hg (data not shown). Improvements in the control of glycated hemoglobin levels occurred between the first two survey periods, whereas the improvements in blood pressure and LDL cholesterol levels occurred gradually over the entire 12-year period.

Table 3 Table 3 Opens a popup window Figure 1 Figure 1 Opens a popup window Opens a popup window

The proportion of U.S. adults with diabetes who were free of microalbuminuria increased by 4.0 percentage points (95% CI, 0.0 to 8.0), and the 10-year risk of coronary heart disease decreased significantly (-2.8 percentage points [UKPDS] and -3.7 percentage points [Framingham Heart Study]). Nevertheless, one third to one half of participants were not meeting the targets for glycated hemoglobin level, blood pressure, or LDL cholesterol level by 2010; 22.3% still smoked; and only 14.3% met the targets for all four risk factors.

A comparison of the data from 2000 and 2008 showed nonsignificant reductions in the percentage of adults with diabetes who were receiving annual eye examinations (-1.7 percentage points; 95% CI, -3.7 to 0.3) or dental examinations (-1.8 percentage points; 95% CI, -6.8 to 3.2). Increases were noted in annual checks of lipid levels (5.5 percentage points; 95% CI, 1.6 to 9.4), annual foot examinations (6.8 percentage points; 95% CI, 4.8 to 8.8), annual influenza vaccinations (4.5 percentage points; 95% CI, 0.8 to 8.2), and receipt of one pneumococcal vaccination (6.9 percentage points; 95% CI, 3.4 to 10.4), as well as at least daily self-monitoring of glucose levels (12.7 percentage points; 95% CI, 10.3 to 15.1), the receipt of diabetes education at diagnosis (5.3 percentage points; 95% CI, 3.0 to 7.6), and the use of ACE inhibitors or ARBs among those eligible for prescriptions (19.0 percentage points; 95% CI, 10.0 to 28.0). In the 2007-2010 surveys, more than 70% of participants reported undergoing annual eye examinations (73.4%), foot examinations (71.4%), and lipid checks (88.2%) and performing self-monitoring of glucose levels (70.9%), whereas 49 to 60% reported receiving vaccinations and 54.6% reported receiving diabetes education. Despite a marked increase (10.9 percentage points; 95% CI, 9.3 to 12.5) over the decade in the proportion of adults with diabetes who underwent annual influenza vaccination and eye and foot examinations, overall, only 22.4% of adults with diabetes met all three criteria in 2008.

CHANGES ACCORDING to RISK GROUP

When individualized, risk-specific targets were used for glycated hemoglobin (Table 4), improvement in glycemic control was observed in every subgroup except younger adults with complications (i.e., persons 18 to 44 years of age with self-reported cardiovascular disease or retinopathy or with an albumin:creatinine ratio of 30 mg of albumin per gram of creatinine or higher [dropping from 39.4% in the 1999-2002 period to 28.2% in the 2007-2010 period]). Cumulatively, across all risk groups, individualized glycemic control improved by 9.4 percentage points (95% CI, 3.0 to 15.8) (data not shown). In the 2007-2010 period, up to three quarters of adults with diabetes who were 45 years of age or older were meeting their glycemic targets.

Table 4 Table 4 Opens a popup window Opens a popup window Opens a popup window

In logistic-regression models adjusted for age, race or ethnic group, educational level, and use or nonuse of insulin (Tables S2 and S3 in the Supplementary Appendix), persons 45 years of age or older had improved care profiles. Also, only those persons with health insurance began with generally better status in the 1999-2002 surveys than uninsured persons and were also more likely to improve with regard to meeting most recommended targets for care.

DISCUSSION

Adults with diabetes in the United States had substantial improvements in the control of risk factors for microvascular and macrovascular disease and in adherence to preventive practices during the period from 1999 to 2010. However, important gaps in care and prevention remain - 30 to 50% did not meet individualized targets for glycemic control, blood pressure, or lipid control, and more than 20% remained smokers. These gaps were particularly noteworthy because tobacco use and hypertension remain the leading modifiable risk factors for death in the United States.27 Adults with diabetes also did not meet goals for preventive practices: 40 to 50% did not receive diabetes education, vaccinations, or annual dental examinations.

We noted that younger adults were less likely than older adults to meet goals for treatment and preventive practices; furthermore, younger adults had no significant improvements in these areas over time. It is unclear whether physician inattentiveness, poor access to health care, or other factors account for these gaps. Because early control of the risk factors for microvascular and macrovascular disease may confer benefits, these results suggest that younger adults with diabetes need further attention.4,5

Historically, 44% of the reduction in U.S. mortality from coronary heart disease has been associated with preventive interventions that reduced the population distribution of risk factors (e.g., reduced tobacco exposure), with the remaining improvements attributed to better treatments (e.g., care provided in coronary care units and the use of revascularization procedures).28 We observed that the proportions of U.S adults with diabetes who monitored glucose levels and met glycemic targets, in particular, increased a few years after the results of the DCCT and UKPDS were published.2,3 Improvements in control of blood pressure and LDL cholesterol levels accrued more gradually from 1999 to 2010. The more recent improvements in preventive practices may be related to the use of quality-of-care measures in comparing provider performance or the use of performance incentives.10,11 However, the benefits of adherence to preventive practices are unclear. Some assessments have shown weak links between adherence to preventive practices and health outcomes,29 whereas others have shown cost savings 30 and longer-term benefits.31 Nonetheless, national surveillance data have shown parallel improvements in risk factors and preventive practices from the 1988-1994 period to the 1999-2002 period 12 and declining rates of amputation, end-stage renal disease, hospitalizations related to cardiovascular disease, hyperglycemic crises, and death since the mid-1990s.32,33

With regard to preventive practices, especially, we noted that once a high level of adherence is achieved, subsequent improvement tends to be marginal.29 For example, increases in the proportion of participants who had their lipid levels checked annually (from 82.7% in the 1999-2002 period to 88.8% in the 2007-2010 period) and the proportion of participants who had annual eye examinations (from 75.1% to 73.4% during the respective periods) appeared to flatten over time. Consequently, our data point to the importance, challenges, and costs of closing residual gaps in care and preventive practices. Similarly, although only 12.6% of participants had glycated hemoglobin levels that were higher than 9.0% in the 2007-2010 period, this is the group at highest risk for the development of microvascular and macrovascular complications and may also have disease that is the most refractory to treatment, as suggested by the findings in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.34

With the evolving evidence, debates over how to optimize care guidelines and performance indicators continue. However, we echo cautions that any revision of quality indicators should be evidence-based, patient-centered, and free of conflicts of interest, and should avoid the simplicity of dichotomous performance measures, which have the potential to harm patients.11,29

There has been renewed support for the individualization of glycemic targets, with the selection of targets based on the risks and benefits given the patient's clinical and socioeconomic profiles.18,19 However, the very nature of individualization makes it a challenge to evaluate the achievement of goals of care in the entire adult population with diabetes. Therefore, we segmented the population into mutually exclusive subgroups based on age and presence or absence of preexisting complications. We found that when targets for glycated hemoglobin level were tailored to the profile of each subgroup, there was greater achievement of the targets than when generic targets were assigned. The probable reason is that individualized targets are generally less intensive. However, further data are needed, especially longitudinal data that allow comparisons across different levels of glycemic control within each risk stratum.

Improved diabetes outcomes result from complex interactions among factors at the patient level (e.g., motivation), the provider level (e.g., therapy intensification), and the system level (e.g., organization of and patient access to care). Although it is possible that more widespread screening for diabetes over the study period has led to earlier detection and therefore may have made targets more achievable for a younger population with less severe diabetes, national surveillance data show that the mean and median age at diagnosis have not varied since 1980, and our data show a stable distribution for time since diagnosis over the 12-year study period.33 In addition, during the past 15 to 20 years, U.S. adults with diabetes have been receiving prescriptions for more, increasingly complex, and costlier medications.35 Last, limited access to care and lower socioeconomic status continue to be related to suboptimal control of risk factors.36 Our findings concur with previous reports: health insurance coverage was significantly and consistently associated with better, more improved risk-factor profiles and preventive practices during the 12 years examined in our study.37,38 Unfortunately, the proportion of persons with diabetes who do not have health insurance has remained the same, despite increases in mean income and educational level over the study period.

Relevant but nonrepresentative trend data from specific third-party payers (commercial plans, Medicaid, and Medicare) provide an important source of comparison with our data. For the 2007-2010 period in our study, 79.1% of survey participants had glycated hemoglobin levels that were lower than 8.0%, 72.2% had blood pressure that was lower than 140/90 mm Hg, 56.8% had LDL cholesterol levels that were lower than 100 mg per deciliter, and 73.4% underwent annual eye examinations; the respective percentages for those covered by commercial plans and Medicare from 2009 through 2011 ranged from 48.0 to 65.6%, 46.3 to 65.8%, 36.8 to 52.5%, and 42.6 to 66.0%.39 These differences probably represent differences in the severity of disease among the populations surveyed.

This study has some limitations. First, our analyses were confined to persons with a self-reported diagnosis of diabetes. Although persons with undiagnosed diabetes constitute a quarter of all those affected by diabetes,1 the inclusion of such persons in our study would have resulted in different risk-factor and adherence profiles, since awareness of disease status is a key aspect of achieving goals for care. Second, recall and social-desirability bias are inherent limitations of self-reported data. Third, data for LDL cholesterol were available only for participants who fasted before testing (e.g., participants taking insulin were excluded). Fourth, we used updated guidelines with more stringent targets than previously recommended (e.g., LDL cholesterol level <100 mg per deciliter) and different, contemporary practices (e.g., not including aspirin use as a standard performance indicator, since aspirin is now recommended only for those with an intermediate risk of cardiovascular disease and a low risk of bleeding).9 However, our definitions of targets were applied consistently throughout the survey periods. Finally, because we used cross-sectional surveys, the changes observed reflect only the risk profiles of the diabetes population at the time of the individual surveys.

Our study has several strengths. We used data from successive, nationally representative surveys to illustrate trends in the U.S. population with diabetes, and we used a combination of established and nontraditional performance indicators and thresholds. In particular, we applied an innovative segmentation approach to estimate the achievement of individualized glycemic targets.

In conclusion, our findings provide nationally representative snapshots of risk-factor control and preventive practices between 1999 and 2010 among U.S. adults with diabetes, identify residual gaps in the quality of care, and reveal the factors influencing these gaps. Preventive practices, glycemic control, and lipid control all improved during this period, but little progress was made in addressing the problems of tobacco use, blood pressure, and the flattening of improvements in preventive practices. Furthermore, continued increases in the incidence of diabetes suggest that the absolute numbers of affected persons and those with poor control of risk factors continue to grow. Continued nationwide evaluation of diabetes control will be important to sustain improvements in care and to evaluate the effects of upcoming legislative changes, new insurance products (e.g., reduced copayments for essential treatments),38,40 and the increased integration of care management models into systems of care.

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