Quality improvement strategies for type 2 diabetes.
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Diabetes Mellitus, Type 2↗
Biomedical subjects
Rodney A Hayward
Publications and source records attributed to Rodney A Hayward.
Effectiveness of implantable cardioverter-defibrillators in patients with ischemic heart disease and left ventricular dysfunction.
BACKGROUND: Implantable cardioverter-defibrillators (ICDs) have been shown in primary prevention efficacy trials to reduce mortality in patients with ischemic heart disease and left ventricular dysfunction. To investigate the generalizabilty of this mortality reduction, we examined the effectiveness of ICDs in clinical practice. METHODS: We developed a prospective multicenter cohort of 770 patients with ischemic left ventricular dysfunction (ejection fraction < or =35%) and without a history of ventricular arrhythmia, of whom 395 (52%) received ICDs. Mean +/- SD follow-up was 27 +/- 12 months. We assessed the degree to which ICDs decreased mortality risk using Cox proportional hazards analyses that controlled for clinical predictors of death, receipt of ICD (a propensity score analysis), and predictors of arrhythmic death (including electrophysiologic variables). RESULTS: Multivariate Cox analyses showed that those with ICDs had significantly lower all-cause mortality (hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.33-0.86). This mortality reduction was mediated through dramatically lower arrhythmia-related mortality (HR, 0.35; 95% CI, 0.17-0.73), with no significant effect on cardiovascular nonarrhythmic (HR, 0.81; 95% CI, 0.34-1.96) and noncardiovascular (HR, 0.76; 95% CI, 0.29-2.05) mortality. No differences were found between the ICD and non-ICD groups for a composite outcome of all-cause mortality, appropriate ICD shocks, or documented symptomatic ventricular arrhythmia, which suggests that the 2 groups had similar baseline risk for life-threatening arrhythmic events (HR, 0.96; 95% CI, 0.63-1.45). CONCLUSION: In clinical practice, ICDs appear to reduce all-cause and arrhythmic rates of mortality at levels similar to those found in primary prevention trials.
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Patients, privacy and trust: patients' willingness to allow researchers to access their medical records.
The federal Privacy Rule, implemented in the United States in 2003, as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), created new restrictions on the release of medical information for research. Many believe that its restrictions have fallen disproportionately on researchers prompting some to call for changes to the Rule. Here we ask what patients think about researchers' access to medical records, and what influences these opinions. A sample of 217 patients from 4 Veteran Affairs (VA) facilities deliberated in small groups at each location with the opportunity to question experts and inform themselves about privacy issues related to medical records research. After extensive deliberation, these patients were united in their inclination to share their medical records for research. Yet they were also united in their recommendations to institute procedures that would give them more control over whether and how their medical records are used for research. We integrated qualitative and quantitative results to derive a better understanding of this apparent paradox. Our findings can best be presented as answers to questions related to five dimensions of trust: Patients' trust in VA researchers was the most powerful determinant of the kind of control they want over their medical records. More specifically, those who had lower trust in VA researchers were more likely to recommend a more stringent process for obtaining individual consent. Insights on the critical role of trust suggest actions that researchers and others can take to more fully engage patients in research.
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Narrative review: lack of evidence for recommended low-density lipoprotein treatment targets: a solvable problem.
Recent national recommendations have proposed that physicians should titrate lipid therapy to achieve low-density lipoprotein (LDL) cholesterol levels less than 1.81 mmol/L (<70 mg/dL) for patients at very high cardiovascular risk and less than 2.59 mmol/L (<100 mg/dL) for patients at high cardiovascular risk. To examine the clinical evidence for these recommendations, the authors sought to review all controlled trials, cohort studies, and case-control studies that examined the independent relationship between LDL cholesterol and major cardiovascular outcomes in patients with LDL cholesterol levels less than 3.36 mmol/L (<130 mg/dL). For those with LDL cholesterol levels less than 3.36 mmol/L (<130 mg/dL), the authors found no clinical trial subgroup analyses or valid cohort or case-control analyses suggesting that the degree to which LDL cholesterol responds to a statin independently predicts the degree of cardiovascular risk reduction. Published studies had avoidable limitations, such as a reliance on ecological (aggregate) analyses, use of analyses that ignore statins' other proposed mechanisms of action, and failure to account for known confounders (especially healthy volunteer effects). Clear, compelling evidence supports near-universal empirical statin therapy in patients at high cardiovascular risk (regardless of their natural LDL cholesterol values), but current clinical evidence does not demonstrate that titrating lipid therapy to achieve proposed low LDL cholesterol levels is beneficial or safe.
Anticholesteremic Agents↗
Keeping apples and oranges separate: reassessing clinical trials that use composite end points as their primary outcome.
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Cardiovascular Diseases↗
High-dose statins and the IDEAL study.
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Clinical Trials as Topic↗
Multivariable risk prediction can greatly enhance the statistical power of clinical trial subgroup analysis.
BACKGROUND: When subgroup analyses of a positive clinical trial are unrevealing, such findings are commonly used to argue that the treatment's benefits apply to the entire study population; however, such analyses are often limited by poor statistical power. Multivariable risk-stratified analysis has been proposed as an important advance in investigating heterogeneity in treatment benefits, yet no one has conducted a systematic statistical examination of circumstances influencing the relative merits of this approach vs. conventional subgroup analysis. METHODS: Using simulated clinical trials in which the probability of outcomes in individual patients was stochastically determined by the presence of risk factors and the effects of treatment, we examined the relative merits of a conventional vs. a "risk-stratified" subgroup analysis under a variety of circumstances in which there is a small amount of uniformly distributed treatment-related harm. The statistical power to detect treatment-effect heterogeneity was calculated for risk-stratified and conventional subgroup analysis while varying: 1) the number, prevalence and odds ratios of individual risk factors for risk in the absence of treatment, 2) the predictiveness of the multivariable risk model (including the accuracy of its weights), 3) the degree of treatment-related harm, and 5) the average untreated risk of the study population. RESULTS: Conventional subgroup analysis (in which single patient attributes are evaluated "one-at-a-time") had at best moderate statistical power (30% to 45%) to detect variation in a treatment's net relative risk reduction resulting from treatment-related harm, even under optimal circumstances (overall statistical power of the study was good and treatment-effect heterogeneity was evaluated across a major risk factor [OR = 3]). In some instances a multi-variable risk-stratified approach also had low to moderate statistical power (especially when the multivariable risk prediction tool had low discrimination). However, a multivariable risk-stratified approach can have excellent statistical power to detect heterogeneity in net treatment benefit under a wide variety of circumstances, instances under which conventional subgroup analysis has poor statistical power. CONCLUSION: These results suggest that under many likely scenarios, a multivariable risk-stratified approach will have substantially greater statistical power than conventional subgroup analysis for detecting heterogeneity in treatment benefits and safety related to previously unidentified treatment-related harm. Subgroup analyses must always be well-justified and interpreted with care, and conventional subgroup analyses can be useful under some circumstances; however, clinical trial reporting should include a multivariable risk-stratified analysis when an adequate externally-developed risk prediction tool is available.
Clinical Trials as Topic↗
What effect does physician "profiling" have on inpatient physician satisfaction and hospital length of stay?
BACKGROUND: 2002 marked the first time that the rate of hospital spending in the United States out-paced the overall health care spending rate of growth since 1991. As hospital spending continues to grow and as reimbursement for hospital expenses has moved towards the prospective payment system, there is still increasing pressure to reduce costs. Hospitals have a major incentive to decrease resource utilization, including hospital length of stay. We evaluated whether physician profiling affects physician satisfaction and hospital length of stay, and assessed physicians' views concerning hospital cost containment and the quality of care they provide. METHODS: To determine if physician profiling affects hospital length of stay and/or physician satisfaction, we used quasi-experimental with before-versus-after and intervention-versus-control comparisons of length of stay data collected at an intervention and six control hospitals. Intervention hospital physicians were informed their length of stay would be compared to their peers and were given a questionnaire assessing their experience. RESULTS: Nearly half of attending pre-profiled physicians felt negative about the possibility of being profiled, while less than one-third of profiled physicians reported feeling negative about having been profiled. Nearly all physicians greatly enjoyed their ward month. Length of stay at the profiled site decreased by an additional 1/3 of a day in the profiling year, compared to the non-profiled sites (p < 0.001). CONCLUSION: A relatively non-instrusive profiling intervention modestly reduced length of stay without adversely affecting physician satisfaction.
Adult↗
Can school income and racial/ethnic composition explain the racial/ethnic disparity in adolescent physical activity participation?
OBJECTIVE: Our goal was to determine if racial/ethnic disparities in adolescent boys' and girls' physical activity participation exist and persist once the school attended is considered. METHODS: We performed a cross-sectional analysis of 17,007 teens in the National Longitudinal Study of Adolescent Health. Using multivariate linear regression, we examined the association between adolescent self-reported physical activity and individual race/ethnicity stratified by gender, controlling for a wide range of sociodemographic, attitudinal, behavioral, and health factors. We used multilevel analyses to determine if the relationship between race/ethnicity and physical activity varied by the school attended. RESULTS: Participants attended racially segregated schools; approximately 80% of Hispanic and black adolescent boys and girls attended schools with student populations that were <66% white, whereas nearly 40% of the white adolescents attended schools that were >94% white. Black and Hispanic adolescent girls reported lower levels of physical activity than white adolescent girls. There were more similar levels of physical activity reported in adolescent boys, with black boys reporting slightly more activities. Although black and Hispanic adolescent girls were more likely to attend poorer schools with overall lower levels of physical activity in girls; there was no difference within schools between black, white, and Hispanic adolescent girls' physical activity levels. Within the same schools, both black and Hispanic adolescent boys had higher rates of physical activity when compared with white adolescent boys. CONCLUSIONS: In this nationally representative sample, lower physical activity levels in Hispanic and black adolescent girls were largely attributable to the schools they attended. In contrast, black and Hispanic males had higher activity levels than white males when attending the same schools. Future research is needed to determine the mechanisms through which school environments contribute to racial/ethnic disparities in adolescent physical activity and will need to consider gender differences in these racial/ethnic disparities.
Adolescent↗
Mortality reduction by implantable cardioverter-defibrillators in high-risk patients with heart failure, ischemic heart disease, and new-onset ventricular arrhythmia: an effectiveness study.
OBJECTIVES: To investigate the generalizability of the reduction in mortality posed by implantable cardioverter-defibrillators, we examined the effectiveness of defibrillators as applied in routine medical practice. BACKGROUND: Implantable cardioverter-defibrillators have been shown to be efficacious in the primary and secondary prevention of overall and cardiovascular mortality in clinical trials. METHODS: Using the National Veterans Administration database, we identified a cohort of 6,996 patients from 1995 to 1999 with new-onset ventricular arrhythmia and pre-existing ischemic heart disease and congestive heart failure, of which 1,442 received a defibrillator, and followed them for three years to determine rates of mortality. With multivariate logistic regression analyses that adjusted for demographics, illness severity, and comorbidity, we assessed overall, cardiovascular, and noncardiovascular rates of mortality. To further address potential confounding, we also stratified the cohort by quintiles using a multivariable propensity score for each patient and determined mortality rates. RESULTS: For the overall cohort, multivariate regression showed that those who received defibrillators had significantly lower all-cause (odds ratio [OR] 0.52; 95% confidence interval [CI] 0.45 to 0.60) and cardiovascular (OR 0.56; 95% CI 0.49 to 0.65)] rates of mortality at three years. No significant differences were noted between groups in their rates of noncardiovascular mortality (OR 0.92; 95% CI 0.77 to 1.10). Propensity score analysis demonstrated similar mortality reduction benefits at three years: risk ratio (RR) 0.72 (95% CI 0.69 to 0.79) for all-cause; RR 0.70 (95% CI 0.63 to 0.78) for cardiovascular; and RR 0.95 (95% CI 0.83 to 1.08) for noncardiovascular rates of mortality. These results suggest that one death is prevented in this patient population for every four to five patients receiving a defibrillator for three years. CONCLUSIONS: Implantable cardioverter-defibrillators in routine medical practice significantly reduce cardiovascular and all-cause rates of mortality at levels similar to secondary prevention trials.
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Physician perceptions of upper extremity reconstruction for the person with tetraplegia.
PURPOSE: Upper extremity reconstruction for people with tetraplegia can improve upper-limb function substantially and enhance independence; however, these surgical procedures rarely are performed. This study attempted to identify barriers preventing appropriate candidates from receiving these procedures. METHODS: A questionnaire was mailed to a national sample of 379 hand surgeons and 384 physiatrists with an interest in spinal cord medicine. The statistical model assessed 2 main outcomes of the physician survey: (1) whether the provider had been involved in at least one of these procedures in the past year and (2) whether the provider desired to be more involved. We hypothesized that these outcomes were associated with provider attitudes and beliefs and failures of the health care system referral networks. RESULTS: Most hand surgeons and physiatrists believed that these procedures were beneficial; however, few had either performed or referred even one case over the past year. Multivariable models suggested that a predominant factor in whether these procedures were being performed was the presence of a relationship between the surgeon and physiatrist. CONCLUSIONS: A lack of coordinated cross-specialty relationships appears to present the largest barrier to the appropriate use of upper extremity reconstruction for people with tetraplegia.
Attitude of Health Personnel↗
CKD progression and mortality among older patients with diabetes.
BACKGROUND: Chronic kidney disease (CKD) is clearly associated with an increased risk for adverse outcomes; however, the cumulative impact of renal and cardiac complications in high-risk populations is not known. In addition, little is known about patterns of nephrology care in patients with CKD. METHODS: We conducted a retrospective longitudinal cohort study assessing CKD prevalence and progression, associations with all-cause mortality, and variations in patterns of nephrology consultation in older patients with diabetes in a vertically integrated health care system. RESULTS: A total of 12,570 patients within a 7-Veterans Affairs hospital service network in 1998 to 1999 were identified by means of computerized records. Nearly half (48%) were affected with CKD; most had mild to moderate CKD. After an observation period of 3 years, mortality rates in those unaffected with CKD were high (4.7 deaths/100 person-years) and increased substantially with progressive CKD (eg, 20.1 deaths/100 person-years with an estimated glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2 [0.25 to 0.48 mL/s/1.73 m2]). Only 7.2% of patients with CKD had a nephrology visit during the entire 5-year study period. Although visits increased with more advanced CKD, only 32% of patients with an estimated GFR of 15 to 29 mL/min/1.73 m2 had been seen in a nephrology clinic. We also found that nephrology referrals were driven preferentially by elevations in serum creatinine levels, rather than low GFRs. CONCLUSION: Many in this cohort of older patients with diabetes are affected with CKD. Mortality rates are high, and mortality risks associated with CKD amplify those of other risk factors. Nephrology visits are low and may represent an unexploited resource for improving CKD management. Underrecognition of CKD likely is related to overestimation of kidney function by relying on serum creatinine level in elderly patients.
Age Factors↗
Brief report: the burden of diabetes therapy: implications for the design of effective patient-centered treatment regimens.
BACKGROUND: Management of diabetes, and in particular blood glucose, can be complex and burdensome. OBJECTIVE: To evaluate patient views of the burdens of therapy and its impact on self-management. PATIENTS: Veteran patients with type 2 diabetes. DESIGN: Mailed survey. MEASUREMENTS: Patients described their views of the burden of diabetes treatments, adherence, and clinical and demographic status. Factors associated with ratings of burden and adherence to therapy were examined using multivariate regression methods. RESULTS: The response rate was 67% (n=1,653). Patients viewed pills as the least burdensome treatment and insulin as the most burdensome. Ratings of the burden of insulin were lower if a patient had prior experience with therapy. Adherence to prescribed therapy varied substantially; for example, patients followed medication recommendations more closely than other areas of self-management. Multivariate analyses showed that the main predictor of adherence was patients' ratings of the burden of therapy. CONCLUSIONS: Injected insulin regimens are viewed as highly burdensome by patients, although this burden is attenuated by experience. Adherence to self-management is strongly and independently correlated with views of treatment burden. The burden of diabetes-related treatments may be a source of suboptimal glucose control seen in many care settings. Providers should consider the burden of treatment for a particular patient and its impact on adherence as part of a decision-making process to design effective treatment regimens.
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Sins of omission: getting too little medical care may be the greatest threat to patient safety.
BACKGROUND: Little is known about the relative incidence of serious errors of omission versus errors of commission. OBJECTIVE: To identify the most common substantive medical errors identified by medical record review. DESIGN: Retrospective cohort study. SETTING: Twelve Veterans Affairs health care systems in 2 regions. PARTICIPANTS: Stratified random sample of 621 patients receiving care over a 2-year period. MAIN OUTCOME MEASURE: Classification of reported quality problems. METHODS: Trained physicians reviewed the full inpatient and outpatient record and described quality problems, which were then classified as errors of omission versus commission. RESULTS: Eighty-two percent of patients had at least 1 error reported over a 13-month period. The average number of errors reported per case was 4.7 (95% confidence intervals [CI]: 4.4, 5.0). Overall, 95.7% (95% CI: 94.9%, 96.4%) of errors were identified as being problems with underuse. Inadequate care for people with chronic illnesses was particularly common. Among errors of omission, obtaining insufficient information from histories and physicals (25.3%), inadequacies in diagnostic testing (33.9%), and patients not receiving needed medications (20.7%) were all common. Out of the 2,917 errors identified, only 27 were rated as being highly serious, and 26 (96%) of these were errors of omission. CONCLUSIONS: While preventing iatrogenic injury resulting from medical errors is a critically important part of quality improvement, we found that the overwhelming majority of substantive medical errors identifiable from the medical record were related to people getting too little medical care, especially for those with chronic medical conditions.
Acute Disease↗
Causes of preventable visual loss in type 2 diabetes mellitus: an evaluation of suboptimally timed retinal photocoagulation.
To examine circumstances surrounding suboptimally timed retinal photocoagulation, we reviewed the medical records of 238 patients who had received photocoagulation for diabetic retinopathy at one of three large referral centers. Forty-three percent (95% confidence interval, 36% to 49%) of cases were rated as probably or definitely suboptimally timed (i.e., patient could have benefited from earlier photocoagulation). About one third of cases were due to patients going many years without screening (> 3 years), and two thirds were associated with surveillance problems (failures to achieve close follow-up for known retinopathy). We found that suboptimal timing of photocoagulation was common but was not due to patients going between 13 and 36 months between screening visits, suggesting that current performance measures, which focus on annual retinal examinations, may be requiring wasteful care while not addressing a major quality problem.
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Proactive case management of high-risk patients with type 2 diabetes mellitus by a clinical pharmacist: a randomized controlled trial.
OBJECTIVE: To evaluate the effect of case management by a clinical pharmacist on glycemic control and preventive measures in patients with type 2 diabetes mellitus. STUDY DESIGN: Randomized controlled trial in a university-affiliated primary care internal medicine clinic. METHODS: We recruited 80 patients with poorly controlled type 2 diabetes mellitus. A clinical pharmacist provided evaluation and modification of pharmacotherapy, self-management diabetes education, and reinforcement of diabetes complications screening processes through clinic visits and telephone follow-up. The main clinical outcome was hemoglobin A1C (HbA1C) level; process measures included HbA1C and low-density lipoprotein measurement, retinal examination, urine microalbumin testing (or use of angiotensin-converting enzyme inhibitors), and monofilament screening for diabetic neuropathy. RESULTS: Patients in the intervention and control groups were similar in age, sex, mean HbA1C levels (10.1% and 10.2%, respectively; P = .65), and current treatment regimens at baseline. Patients who received case management by the clinical pharmacist achieved greater reduction in HbA1C levels than those in the control group (2.1% vs 0.9%, P = .03). Three of the 5 process measures were conducted more frequently in the intervention group than the control group, including low-density lipoprotein measurement (100.0% vs 85.7%, P = .02), retinal examination (97.3% vs 74.3%), and monofilament foot screening (92.3% vs 62.9%). CONCLUSIONS: Proactive diabetes case management by a pharmacist substantially improved glycemic control and diabetes process-of-care measures. This approach, integrated with and based in the primary care setting, was an effective and efficient approach to improving care, especially for those with poor glycemic control at baseline.
Blood Glucose↗
Comparison of quality of care for patients in the Veterans Health Administration and patients in a national sample.
BACKGROUND: The Veterans Health Administration (VHA) has introduced an integrated electronic medical record, performance measurement, and other system changes directed at improving care. Recent comparisons with other delivery systems have been limited to a small set of indicators. OBJECTIVE: To compare the quality of VHA care with that of care in a national sample by using a comprehensive quality-of-care measure. DESIGN: Cross-sectional comparison. SETTING: 12 VHA health care systems and 12 communities. PATIENTS: 596 VHA patients and 992 patients identified through random-digit dialing. All were men older than 35 years of age. MEASUREMENTS: Between 1997 and 2000, quality was measured by using a chart-based quality instrument consisting of 348 indicators targeting 26 conditions. Results were adjusted for clustering, age, number of visits, and medical conditions. RESULTS: Patients from the VHA scored significantly higher for adjusted overall quality (67% vs. 51%; difference, 16 percentage points [95% CI, 14 to 18 percentage points]), chronic disease care (72% vs. 59%; difference, 13 percentage points [CI, 10 to 17 percentage points]), and preventive care (64% vs. 44%; difference, 20 percentage points [CI, 12 to 28 percentage points]), but not for acute care. The VHA advantage was most prominent in processes targeted by VHA performance measurement (66% vs. 43%; difference, 23 percentage points [CI, 21 to 26 percentage points]) and least prominent in areas unrelated to VHA performance measurement (55% vs. 50%; difference, 5 percentage points [CI, 0 to 10 percentage points]). LIMITATIONS: Unmeasured residual differences in patient characteristics, a lower response rate in the national sample, and differences in documentation practices could have contributed to some of the observed differences. CONCLUSIONS: Patients from the VHA received higher-quality care according to a broad measure. Differences were greatest in areas where the VHA has established performance measures and actively monitors performance.
Cross-Sectional Studies↗
Case management for patients with poorly controlled diabetes: a randomized trial.
PURPOSE: To evaluate the effects of a collaborative case management intervention for patients with poorly controlled type 2 diabetes on glycemic control, intermediate cardiovascular outcomes, satisfaction with care, and resource utilization. METHODS: We conducted a randomized controlled trial at two Department of Veterans Affairs Medical Centers involving 246 veterans with diabetes and baseline hemoglobin A(1C) (HbA(1C)) levels >or=7.5%. Two nurse practitioner case managers worked with patients and their primary care providers, monitoring and coordinating care for the intervention group for 18 months through the use of telephone contacts, collaborative goal setting, and treatment algorithms. Control patients received educational materials and usual care from their primary care providers. RESULTS: At the conclusion of the study, both case management and control patients remained under poor glycemic control and there was little difference between groups in mean exit HbA(1C) level (9.3% vs. 9.2%; difference = 0.1%; 95% confidence interval: -0.4% to 0.7%; P = 0.65). There was also no evidence that the intervention resulted in improvements in low-density lipoprotein cholesterol level or blood pressure control or greater intensification in medication therapy. However, intervention patients were substantially more satisfied with their diabetes care, with 82% rating their providers as better than average compared with 64% of patients in the control group (P = 0.04). CONCLUSION: An intervention of collaborative case management did not improve key physiologic outcomes for high-risk patients with type 2 diabetes. The type of patients targeted for intervention, organizational factors, and program structure are likely critical determinants of the effectiveness of case management. Health systems must understand the potential limitations before expending substantial resources on case management, as the expected improvements in outcomes and downstream cost savings may not always be realized.
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