Abstract
Background
Performance measures that emphasize only a treat-to-target approach may motivate overtreatment with high dose statins, potentially leading to adverse events and unnecessary costs. We developed a clinical action performance measure for lipid management in patients with diabetes that is designed to encourage appropriate treatment with moderate dose statins while minimizing overtreatment.
Methods and Results
We examined data from July 2010 to June 2011 for 964,818 active VA primary care patients >=18 years with diabetes. We defined 3 conditions as successfully meeting the clinical action measure for patients 50-75 years old: 1) LDL < 100 mg/dL; 2) On a moderate dose statin, regardless of LDL level or measurement; or 3) If LDL > 100 mg/dL, received appropriate clinical action (starting, switching or intensifying statin therapy). We examined possible overtreatment for patients 18 and older by examining the proportion of patients without ischemic heart disease who were on a high dose statin. We then examined variability in measure attainment across 881 facilities using two level hierarchical multivariable logistic models. Of 668,209 patients with diabetes aged 50-75 years, 84.6% passed the clinical action measure: 67.2% with LDL <100 mg/dL; 13.0% with LDL >=100 mg/dL and on either a moderate dose statin (7.5%) or with appropriate clinical action (5.5%); and 4.4% with no index LDL on at least a moderate dose statin. Of the entire cohort aged >=18 years, 13.7% were potentially overtreated. Facilities with higher rates of meeting the current threshold measure (LDL <100 mg/dL) had higher rates of potential overtreatment (p <0.001).
Conclusions
Use of a performance measure that credits appropriate clinical action indicates that almost 85% of diabetic Veterans aged 50-75 are receiving appropriate dyslipidemia management. However, many patients are potentially overtreated with high dose statins.
Keywords: Cholesterol, Performance Measures, Quality of Care, Diabetes Mellitus, Lipids
Background
Extensive research has demonstrated that statins reduce the risk of macrovascular complications in patients with diabetes.1-3 While the mantra of “lower is better” for LDL levels is commonly quoted and is the basis of much of our quality measurement, there are reasons to question this belief. First, most available evidence of benefit in reduction of cardiovascular events as a result of lipid therapy focuses on treatment with fixed dose statins, not treatment to achieve particular LDL targets or progressive intensification of therapy to meet targets.2-15 Second, existing experimental evidence of cardiovascular event reduction is strongest for use of moderate dose statins in patients with diabetes.2, 3, 11, 16 Despite the design of the studies and the evidence pointing to the benefit of moderate dose statins, however, most national guidelines and performance measures stress achievement of a dichotomous, threshold LDL target (e.g., LDL <100 mg/dL [<2.59 mmol/L]),17-21 and more patients are being treated and achieving these LDL targets than ever before.22-26
Recent analyses of cardiovascular prevention studies,6 as well as recognition that high dose statins have significant toxicities, raise concerns about the appropriateness of focusing on LDL targets rather than on appropriate treatment. Indeed, beyond the design of the statin studies, striving for low LDL values in all patients may not be an appropriate goal. While higher doses of statins are associated with greater absolute LDL reductions,9 higher doses also are more likely to cause adverse events, including myopathy and rhabdomyolysis.27-32 The significance of these adverse events was underscored by the recent Food and Drug Administration Drug Safety Communication limiting use of the highest simvastatin dose (80mg) because of increased risk of muscle damage.33 Yet, the treat-to-target approach promotes the use of high dose statins in all patients who do not achieve targets with lower doses. Further, attempting to achieve stated targets will often require the use of non-statin LDL-lowering therapy (e.g., fibrates, ezetimibe, or niacin) that have not been shown to benefit outcomes, particularly when combined with statins.34-36
If the ultimate goal of performance measurement is to improve the quality of patient care, then quality measures for dyslipidemia should focus on motivating evidence-based strategies for reducing cardiovascular risk. Indeed, professional societies, including the American College of Cardiology and American Heart Association, now recommend that the adequacy of lipid management be judged by the appropriateness of the therapy and not solely by LDL value.37 We have previously described and validated such measures, termed clinical action measures, which give credit for clinical processes that are strongly associated with important outcomes, such as prescription of moderate dose statins, even when thresholds are not met.38-42 Clinical action performance measures are increasingly being recommended to help make performance measurement more clinically meaningful.37, 40, 43
As part of an effort to refine performance measurement for patients with diabetes, we collaborated with Department of Veterans Affairs (VA) clinical and measurement experts to develop a clinical action performance measure for lipid management in patients with diabetes focused on measuring and promoting appropriate use of statins. We examined performance on this proposed measure among patients with diabetes receiving primary care in the VA during 2010-2011 to assess what proportion would have been receiving appropriate lipid management according to this new clinical action measure versus the treat-to-target measure of LDL<100 mg/dL performance measure that was then in place. In addition, we examined the use of high dose statins for patients without documented ischemic heart disease (IHD) to assess the degree of potential overtreatment. Finally, we examined whether achievement of current treat-to-target thresholds was associated with potential overtreatment.
Methods
Measure Development and Construction
In consultation with clinical and measurement experts, we specified a clinical action performance measure for lipid management in patients with diabetes (Figure 1a). The performance measure focused only on patients age 50-75 because cardiovascular disease risk for both men and women with diabetes increases rapidly beyond age 5044, 45 and limited favorable patient centered clinical outcome evidence (e.g., reduced myocardial infarction (MI), reduced stroke) is available in patients with diabetes under age 50 and over age 75. While some guidelines have considered diabetes an ischemic heart disease equivalent,19 suggesting that all patients with diabetes should be treated with a statin regardless of risk, intervention trial data is lacking except in the 50-75 age range.2, 3 Indeed, a 40-year old woman with diabetes but no other risk factors has a cardiovascular risk lower than 4%. However, by age 50, even most women without other risk factors will have cardiovascular risk above 5%. We specified that the clinical action measure could be met either by achieving the target threshold of LDL <100 mg/dL (either at baseline or, because of measurement variation, a repeat measure within 90 days),17, 19, 20 or by appropriate treatment with at least moderate dose statins when LDL was >=100 mg/dL or not tested (see Figure 1a for measure specification). Moderate dose statins were defined as statin daily doses capable of producing a 30-40% reduction in LDL. The following were considered moderate dose statins (mg/day): atorvastatin [≥10 to <40]; fluvastatin [≥80]; lovastatin and pravastatin [≥40]; rosuvastatin [≥ 5 to <10]; and, simvastatin [≥20 to ≤40] (Supplemental Methods 1). Additionally, the measure gave credit for “appropriate action” (i.e., starting, switching or intensifying statin therapy) even when the statin dose did not yet reach moderate dosing criteria, in order to focus on moving toward moderate doses among patients who might not tolerate higher doses.
Figure 1.
The Clinical Action Measure and the Marker of Potential Overtreatment among Patients with Diabetes
1a - THE CLINICAL ACTION MEASURE IS MET FOR PATIENTS WITH DIABETES, 50-75 YEARS OLD, WHEN:
1b - THE MARKER OF POTENTIAL OVERTREATMENT IS MET FOR PATIENTS WITH DIABETES, 18+ YEARS OLD, WHEN:
We also specified a marker of potential overtreatment that assessed the use of high dose statins among diabetic patients >=18 years old without diagnosed ischemic heart disease (IHD) (see Figure 1b). The following were considered high dose statins (mg/day): atorvastatin [≥40]; rosuvastatin [≥10]; and, simvastatin [>40]. Routine high dose statin use may be appropriate among patients with acute coronary syndrome (ACS).46-50 Although we had complete data on diagnoses of ACS and other IHD related inpatient and outpatient diagnoses within the VA system, we did not have data on acute hospitalizations outside VA. When patients hospitalized outside VA for an acute event are seen back in VA primary or specialty clinics, their IHD diagnosis is captured, but not necessarily the diagnosis of their acute event. To be conservative, therefore, we assumed that all patients with any diagnosis related to IHD (and not just those with ACS) may be appropriately treated with high dose statins.
We looked at potential overtreatment among all patients with diabetes, not only those 50-75, because there is no age threshold for toxicity from statins. Therefore, the marker of potential overtreatment examined the proportion of patients with diabetes but without IHD who were on high dose statins during the measurement period and were therefore exposed to additional risk of treatment side-effects without strong evidence for benefit beyond that received from moderate dose statins.
Cohort Construction and Setting
We performed a retrospective cohort study in the 12-month period from July 1, 2010 to June 30, 2011 (the measurement period) of active VA primary care patients aged 18 and over with an established diagnosis of diabetes mellitus in the 24 months prior to the measurement period (Supplemental Methods 2). The index LDL was defined as the last LDL value recorded in the measurement period. All VA clinics where primary care type services are delivered were included. Only prescriptions filled in the VA were assessed. Data came from 881 facilities (medical centers or freestanding community based outpatient clinics (CBOCs)) in the VA National Corporate Data Warehouse (CDW). During this assessment period, VA’s performance measure for lipid management among patients with diabetes was a treat-to-target measure of LDL < 100 mg/dL.
Statistical Analysis
We determined the number of patients (50-75 years old) who passed the clinical action performance measure and identified the reasons for meeting the measure. We also examined use of high dose statins among the full diabetes cohort and among the potentially overtreated subgroup without IHD. We used two multilevel models in the analysis, one predicting meeting the performance measure and the second predicting overtreatment. A random intercept for facility was used in both models. An empty model with no other covariates was used to calculate the probability of meeting the performance measure and the probability of overtreatment. To assess the potential relationship of cardiovascular risk and intensive treatment we also estimated a model including age and systolic blood pressure as fixed effects. The predicted rates are empirical Bayes estimates which account for the instability of the estimates for small facilities.51 For illustrative purposes, we calculated the predicted rate of overtreatment in the entire diabetes cohort for a 40 year old with a systolic blood pressure (SBP) of 130 (low CV risk) and a 60 year old with a SBP of 150 (high CV risk).
Finally, we calculated the correlation between the predicted facility proportion of meeting the LDL<100 mg/dL measure (the current threshold performance measure in VA) and the proportion meeting the overtreatment marker. To further illustrate the relationship between these two measures, we divided the 881 facilities into quartiles based on meeting the currently employed dichotomous threshold measure of LDL <100 mg/dL. We then examined the association between facility quartile of meeting the current LDL <100 mg/dL measure and overtreatment using a multilevel logistic regression model.
All analyses were conducted using Stata, version 11.2 (Stata, College Station, Texas). The VA Ann Arbor Healthcare System’s Subcommittee on Human Studies approved this study.
Results
There were 964,818 patients in the full diabetes cohort. 668,209 were between 50-75 years of age and thus eligible for the clinical action measure. Table 1 details baseline characteristics and statin use. In the cohort examined for the clinical action measure, the mean LDL in the year prior to the measurement period was 89.3 mg/dL and 27.2% had a diagnosis of IHD. During the 120 days prior to the start of the measurement period, 24.9% patients were on a high dose statin, 32.3% on a moderate dose statin, 7.3% on a low dose stain, and 35.4% not on any statin.
Table1.
Characteristics of the cohort examined for the lipid management clinical action performance measure (age 50-75) and for the marker of potential overtreatment (age 18 and older)
| Clinical Action Performance Measure (50-75 years old only) |
Marker of Potential Overtreatment (18 years and older) |
|||||
|---|---|---|---|---|---|---|
| Characteristic | Value | Sample, n |
Value | Sample, n |
||
| N | 668,209 | 964,818 | ||||
| Age, mean (SD) | 63.8 | (6.1) | 668,209 | 67.4 | (10.8) | 964,818 |
| Male, % | 96.7 | 646,429 | 96.9 | 934,431 | ||
| Most recent hemoglobin A1c (%), mean (SD)1 |
7.3 | (1.4) | 597,364 | 7.2 | (1.4) | 844,999 |
| Systolic blood pressure (mm Hg), mean (SD)1 |
132.1 | (13.6) | 632,492 | 132.2 | (13.8) | 911,098 |
| Diastolic blood pressure (mm Hg), mean (SD)1 |
74.7 | (9.0) | 632,492 | 73.3 | (9.5) | 911,098 |
| Low-density lipoprotein (mg/dL), mean (SD)1 |
89.3 | (29.3) | 591,802 | 88.4 | (29.1) | 834,862 |
| Ischemic heart disease, %1 | 27.2 | 181,937 | 29.3 | 282,538 | ||
| On a moderate dose statin at start of measurement period, %2 |
32.3 | 216,117 | 33.0 | 318,691 | ||
| On a high dose statin at start of measurement period, %2 |
24.9 | 166,366 | 22.7 | 218,807 | ||
Time period examined: 365 days prior to the start of the measurement period
A patient was considered to be on a moderate or high dose statin (see Table 1 in Supplemental Methods 1 for dose ranges defined as moderate or high) if they had a medication fill within the 120 days prior to the start of the measurement period. The highest dose filled during that time period was considered the medication dose.
Clinical Action Performance Measure
Among diabetic patients 50-75 years old, 67.2% had an LDL < 100 mg/dL and thus met both the standard treat-to-target performance measure and the clinical action performance measure. (Of those with an LDL < 100 mg/dL, 22.9% were not on any statin, 8.2% were on a low dose statin, 38.0% were on a moderate dose statin, and 30.8% were on a high dose statin.) Another 17.4% met the clinical action measure because of appropriate actions, for a total of 84.6% (N=564,998) (Figure 2a and Table 2). Of this latter group, 11.9% had an LDL > 100 mg/dL but were on a moderate dose statin at the time of the index LDL measurement or within 90 days; 1.0% had a statin started or increased; 0.1% had a repeat LDL < 100 mg/dL within 90 days; and 4.4% had no LDL measured, but were on a moderate dose statin.
Figure 2a.
Quality of Care by the Linked Action Measure is Met in 84.6% of Patients
Table 2.
Reasons for passing the clinical action performance measure for lipid management among diabetic patients age 50-75 (N=668,209)
| Hierarchical* | Total** | |||
|---|---|---|---|---|
| Reason | N | % | N | % |
| Index LDL < 100 mg/dL | 448,738 | 67.2 | 448,738 | 67.2 |
| On at least a moderate dose statin at the time of the index LDL1 |
50,032 | 7.5 | 317,736 | 47.6 |
| Appropriate clinical action within 90 days following the index LDL (includes index LDL date) |
||||
| On at least a moderate dose statin | 29,571 | 4.4 | 70,627 | 10.6 |
| Increase of statin dose (at a dose lower than moderate dose) |
481 | 0.1 | 4,953 | 0.7 |
| Start or change statin (at a dose lower than moderate dose) |
5,727 | 0.9 | 86,355 | 12.9 |
| Repeat LDL value < 100 mg/dL | 775 | 0.1 | 19,099 | 2.9 |
| No Index LDL, but received a fill for a moderate dose statin or higher during at end of measurement period2 |
29,674 | 4.4 | 29,674 | 4.4 |
| MEETS THE CLINICAL ACTION MEASURE | 564,998 | 84.6 | 564,998 | 84.6 |
| DOES NOT MEET THE MEASURE | 103,211 | 15.4 | 103,211 | 15.4 |
Patient can meet the measure based on only one reason, in the order listed
Patient can meet the measure based on all reasons for which they qualify
Patients were considered to already be on a statin if they had a medication fill within 100 days prior to the Index LDL;
During the last 120 days of the measurement period.
Of note, overall 62.6% of patients 50-75 years old (N=418,375) were on at least a moderate dose statin (28.5% of these (N=190,616) were on a high dose) during the measurement period. Of the remaining patients, 7.7% were on a low dose statin and 29.7% were not on any statin. Of those not on a statin, 51.9% had an index LDL < 100. There was substantial variation across the facilities in predicted probability of meeting the clinical action measure, ranging from 72.2% to 90.2% for a facility at the 5th percentile to the 95th percentile in pass rates (Chi-squared=9454.64, p<0.001 for the likelihood ratio test of the effect of facility on probability of meeting the test).
Approximately 15.4% of the cohort did not meet the clinical action measure (N=103,211). 8.1% of the cohort (N=54,371) had an LDL>100 mg/dL but were not on any statin, 6.0% (N=40,360) had no LDL measurement and were not on a statin and 1.3% (N=8,480) were only on a low dose statin. Patients who did not meet the clinical action measure had fewer primary care visits, on average, during the measurement period than patients who did meet the measure (4.7 visits vs. 6.3 visits; p<.0001, two group mean comparison (t) test).
Use of High dose Statins and Potential Overtreatment
68.3% of diabetes patients 18 years and older were on statins during the measurement period, as compared to 70.3% of diabetes patients 50-75 years old. Among the 68.3% on statins (N=658,950), 37.7% were prescribed a high dose, 50.5% a moderate dose, and 11.8% a low dose. Simvastatin, the preferred formulary agent during the entire measurement period, was the most frequently prescribed statin (73.0%). Furthermore, 13.7% of all diabetic patients were on high dose statins but had no diagnosis of IHD either during or before the measurement period (N=131,772) and were potentially overtreated (Figure 2b). We conducted a sensitivity analysis, also excluding patients with cerebrovascular disease and peripheral vascular disease (in addition to patients with IHD), and the percentage of patients with potential overtreatment decreased from 13.7% to 11.5%.
Figure 2b.
13.7% of Patients with Diabetes have Potential Overtreatment
Facilities varied substantially in high dose statin use among patients without IHD, with predicted rates of potential overtreatment ranging from 8.5% to 18.4% (Chi-squared=6780.18, p<0.001 for the likelihood ratio test of the effect of facility on probability of meeting the test). Predicted probabilities using a two level model that included age and mean SBP in the year prior to the measurement period showed that, at a facility with median rates of overtreatment, the predicted probability of overtreatment for a 40 year old with a SBP 130 was 17.6% (CI:17.3%-18.0%) vs. 14.0% (CI:13.7%-14.3%) for a 60 year old with a SBP 150. The expected direction of these variables would be for higher levels of age and blood pressure (which confer a higher level of cardiovascular risk) to predict a higher probability of intensive treatment. Instead we found paradoxical inverse relationship between cardiovascular risk and likelihood of intensive treatment.
Association between current threshold performance measure and overtreatment
The facility-level correlation between the proportion of patients meeting the current official VA treat-to-target threshold performance measure (LDL <100 mg/dL) measure, and the proportion meeting the overtreatment measure was 0.33 (p<0.0001). Table 3 describes the relationship between facility quartile of meeting the current official VA treat-to-target threshold measure (LDL <100 mg/dL) and potential overtreatment. Facilities in the lowest quartile of meeting the VA quality measure had a predicted probability of overtreatment of 10.7% (CI:10.2%-11.1%) while those in the highest quartile of meeting the threshold measure had a predicted probability of overtreatment of 14.3% (CI:13.8%-14.8%).
Table 3.
Relationship between the proportion of patients per facility meeting the current LDL < 100 mg/dL threshold performance measure and potential overtreatment1
| Proportion of patients per facility meeting the LDL <100 threshold performance measure, by quartile |
Independent effect of current performance on predicted probability (CI) of potential overtreatment2 |
|---|---|
| Lowest quartile (8.4%-60.3%) | 10.7% (10.2-11.1) |
| Second (60.3%-66.5%) | 12.4% (11.9-12.8) |
| Third (66.5%-71.0%) | 13.7% (13.2-14.2) |
| Highest quartile (71.0%-84.0%) | 14.3% (13.8-14.8) |
Potential overtreatment defined as: among all diabetic patients, the proportion of patients without IHD who are prescribed high dose statins.
Predicted probability of potential overtreatment per quartile of meeting the current threshold measures, based on multilevel logistic regression for facilities at the median rate of overtreatment (p<0.001). These estimates isolate the hypothetical effect of a facilities being in different quartiles of current performance if the propensity to overtreat at a sample of facilities was otherwise the same. Given that current performance and potential overtreatment are correlated, the observed probabilities would differ by much more.
Discussion
We developed and examined a clinical action performance measure for lipid management among patients age 50-75 in VHA. We found that 85% of patients met this performance measure, compared to 67% using the traditional metric of achieving an LDL < 100 mg/dL. Even the 67% of patients meeting the intermediate outcome measure of LDL <100 mg/dL is higher than prior published estimates of LDL attainment outside VHA, but it is certainly consistent with trends over time toward lower LDL levels, increasing use of statins (including potential overtreatment with high dose statins), as well as treatment guidelines and performance measures stressing achievement of LDL thresholds in VHA.19, 21, 23, 26
The clinical action measure we developed and which is now implemented in the VA recognizes not just LDL levels, but also the most definitive evidence-based treatment (moderate dose statins) and appropriate responses to LDL levels (starting or increasing statins). This has several effects. First, it represents a broader consensus, since there is ongoing debate about the appropriateness of LDL targets given that nearly all clinical trial evidence (particularly in primary prevention) is based on fixed, low to moderate doses of statin. Second, it limits the potential for overtreatment with higher doses of statins in those without IHD who do not achieve LDL targets. Third, it avoids providing incentives for combination therapy of statins with other lipid lowering agents that have been shown to be ineffective or have no clear evidence supporting their use.
For consistency with current threshold measures, meeting the LDL goal is presented first in the hierarchy (table 2). However, in the future, we may wish to present being on a moderate dose statin first in order to motivate clearly appropriate care. If we reversed the order of credit to focus first on moderate dose statin use, regardless of presence of LDL measurement, approximately 62.6% would currently meet the measure because they were on at least a moderate dose statin, 21.0% because of an LDL <100 mg/dL, and 1.1% because of appropriate clinical actions.
New performance measures for the management of coronary artery disease and hypertension suggested by the American College of Cardiology Foundation, American Heart Association, and others have also promoted giving credit for threshold assessment of LDL at 100 mg/dL or if statins are prescribed.37 These measures have not yet been specified so it is unclear whether they would provide credit for clinical actions such as statin prescription within 90 days and for statin use even when an LDL level is not obtained. Our results show that when these criteria are included an additional 10% of patients are receiving appropriate care. We have shown similar results for hypertension care using clinical action measures.52
We found that 13.7% of patients were being potentially overtreated with high dose statins despite not having IHD. This rate of potential overtreatment is likely conservative, as the evidence supporting use of high dose statins is mixed, particularly in those with stable IHD.27, 53, 54 Furthermore, in our analysis, there was no evidence that the use of high dose statins among those without IHD correlated with cardiovascular risk. A 40 year old without hypertension (a SBP of 130) was more likely to be prescribed high dose statins (17.6% (CI:17.3%-18.0%)) than a 60 year old with a SBP of 150 (14.0% (CI:13.7%-14.3%)).44, 55 This suggests to us that the use of high dose statins with the attendant risks may be more reflexive than based on calculated cardiovascular risk, such as can be obtained from the United Kingdom Prospective Diabetes Study Risk Engine.44
Our examination of use of high dose statins in patients without IHD is not intended as an assessment of performance but rather a marker of possible overtreatment among patients who may benefit from therapy de-intensification. Up to 1% of patients on high dose statins may experience complications like myopathy and rhabdomyolisis.27-31 Physicians and health systems have an obligation to prescribe medications at the doses which are likely to maximize benefit and minimize risk. To do otherwise promotes inefficient and potentially harmful care. Further, rates of potential overtreatment in patients without IHD varied widely among facilities and we found that facilities with high proportions of patients meeting the threshold measure of LDL <100 mg/dL had greater proportions of use of high dose statins. Taken in combination with other findings this suggests that facilities with high rates of meeting a treat-to-target measure of LDL control are more likely to use high dose statins, thus potentially putting patients at risk for harm from overtreatment. Such unintended consequences of performance measurement provide more impetus for implementing measures that focus on appropriate treatment rather than arbitrary threshold targets and which may prompt consideration of deintensification when appropriate. Future longitudinal studies should explicitly explore the link between statin overtreatment and adverse events in “real-world” practice to determine the frequency and importance of these events.
Clinical action performance measures motivate appropriate treatment (and decrease potential overtreatment) by rewarding care processes beyond achievement of a target LDL value. The results of our study demonstrate the feasibility of clinical action performance measures using administrative data derived from electronic medical record data. While not all care systems or insurers have access to comprehensive electronic data that includes laboratory values and prescribing history, our findings suggest that continued use of threshold measures of performance for lipid management, particularly in high performing systems, may promote overtreatment.5, 7, 56 Use of the clinical action measure in this study was not without limitations, however. We were not able to account for medications prescribed outside VHA. We were also unable to assess patient contraindications to statins (such as prior adverse reactions), although we did exclude those with end stage liver and kidney disease. It is possible therefore that even more patients were receiving appropriate care than we were able to capture. Further refinements of the clinical action measure would examine receipt of medications from other sources and definite contraindications to statins.
Additionally, we limited the measure to patients age 50-75 because there is the greatest evidence of benefit in this age group and because all patients with diabetes in this age are at relatively high cardiovascular risk.44 In the meta-analysis of 18,686 diabetic patients in 14 trials of moderate dose statin therapy which showed reduced MIs, inclusion ages for individual trials placed most patients in the 50-75 age range.2 The purpose of a performance measure on lipid management is to highlight care that should definitely be provided base on level 1A evidence from multiple randomized controlled trials or meta-analysis.57 While guidelines might correctly urge providers to consider use of statins in otherwise high risk younger or older old patients with diabetes, performance measures are not intended to guide but rather to mandate care. In the future, an optimally designed performance measure for lipid treatment should define eligibility not only by diagnosis and age but by a measure of cardiovascular risk, such as that derived from a risk equation such as Framingham or UKPDS.44, 55, 58, 59
In summary, we demonstrated the design and use of a clinical action performance measure for lipid management among nearly 700,000 patients with diabetes seen in nearly 900 VHA facilities. High rates of passing the action measure are reflective both of the comprehensive structure of the clinical action measure and the high performing health care system. However, the pattern of use of high dose statins among patients without IHD indicates that providers may be over using high dose statins to achieve the current threshold LDL targets. Use of the clinical action measure has the potential to enhance more appropriate treatment over time by de-emphasizing the attainment of an LDL target and motivating moderate dose statin use. The VHA has committed to implementation and evaluation of the lipid management clinical action measure in 2012.
Supplementary Material
Acknowledgements
We thank Mary Hogan, PhD, RN for assistance with data management and for valuable contributions to an earlier draft of this manuscript. We also thank Drs. Varsha Vimalananda, Joseph Francis and Stephan Fihn for review of the manuscript.
Funding Sources This study was funded by VA QUERI RRP 09-111. Additional support was provided by the VA Diabetes Quality Enhancement Research Initiative (DIB 98-001) and the Measurement Core of the Michigan Diabetes Research & Training Center (NIDDK of The National Institutes of Health [P60 DK-20572]).
Kerr and Hofer - Research grants: This study was funded by VA QUERI RRP 09-111.
Footnotes
Members of the Diabetes Quality Enhancement Research Initiative (QUERI) Workgroup on Clinical Action Measures include: Eve Kerr, MD, MPH; Michelle Lucatorto, DNP; David Aron, MD; William Cushman, MD; John R Downs, MD; Leonard Pogach, MD, MBA; and Sandeep Vijan, MD, MS.
The views expressed in this paper are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the University of Michigan. Dr. Eve Kerr had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Disclosures Beard, Lucatorto, Downs, Klamerus, Holleman – None
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