Ella E. Lyons

Laboratory monitoring of drugs at initiation of therapy in ambulatory care.

BACKGROUND AND OBJECTIVES: Product labeling and published guidelines reflect the importance of monitoring laboratory parameters for drugs with a risk of organ system toxicity or electrolyte imbalance. Limited information exists about adherence to laboratory monitoring recommendations. The objective of this study was to describe laboratory monitoring among ambulatory patients dispensed medications for which laboratory testing is recommended at therapy initiation.DESIGN AND SUBJECTS: We conducted a retrospective cross-sectional analysis of patients in 10 geographically distributed health maintenance organizations who were newly prescribed medications with recommended laboratory test monitoring. The main outcome measure was the proportion of initial drug dispensing without recommended baseline laboratory monitoring for 35 newly initiated drugs or drug classes.RESULTS: One hundred seven thousand, seven hundred sixty-three of 279,354 (39%) initial drug dispensings occurred without recommended laboratory monitoring. Patients without monitoring were younger than patients who had monitoring (median 57 vs 61 years, P<.001). Thirty-two percent of dispensings where a serum creatinine was indicated did not have it evaluated (range across drugs, 12% to 61%); 39% did not have liver function testing (range 10% to 75%); 32% did not have hematologic monitoring (range 9% to 51%); and 34% did not have electrolyte monitoring (range 20% to 62%) (P<.001).CONCLUSIONS: Substantial opportunity exists to improve laboratory monitoring of drugs for which such monitoring is recommended. This study emphasizes the need for research to identify the clinical implications of not conducting recommended laboratory monitoring, existing barriers to monitoring, and methods to improve practice.

Association of Exercise Capacity on Treadmill With Future Cardiac Events in Patients Referred for Exercise Testing

BACKGROUND Little is known about the association between exercise capacity and nonfatal cardiac events in patients referred for exercise treadmill testing (ETT). Our objective was to determine the prognostic importance of exercise capacity for nonfatal cardiac events in a clinical population. METHODS A cohort study was performed of 9191 patients referred for ETT. Median follow-up was 2.7 years. Exercise capacity was quantified as the proportion of age- and sex-predicted metabolic equivalents achieved and categorized as less than 85%, 85% to 100%, and greater than 100%. Individual primary outcomes were myocardial infarction, unstable angina, and coronary revascularization. All-cause mortality was a secondary outcome. RESULTS Patients with lower exercise capacity were more likely to be female (55.38% vs 42.62%); to have comorbidities such as diabetes (23.16% vs 9.61%) and hypertension (59.43% vs 44.05%); and to have abnormal ETT findings such as chest pain on the treadmill (12.09% vs 7.63%), abnormal heart rate recovery (82.74% vs 64.13%), and abnormal chronotropic index (32.89% vs 12.20%). In multivariable analysis, including other ETT variables, lower exercise capacity (<85% of predicted) was associated with increased risk of myocardial infarction (hazard ratio [HR], 2.36; 95% confidence interval [CI], 1.55-3.60), unstable angina (HR, 2.39; 95% CI, 1.78-3.21), coronary revascularization (HR, 1.75; 95% CI, 1.46- 2.08), and all-cause mortality (HR, 2.90; 95% CI, 1.88-4.47) compared with exercise capacity greater than 100% of predicted. CONCLUSION Adjusting for patient characteristics and other ETT variables, reduced exercise capacity was associated with both nonfatal cardiovascular events and mortality in patients referred for ETT.

A Pharmacist-Led, American Heart Association Heart360 Web-Enabled Home Blood Pressure Monitoring Program

Background—To determine whether a pharmacist-led, Heart360-enabled, home blood pressure monitoring (HBPM) intervention improves blood pressure (BP) control compared with usual care (UC). Methods and Results—This randomized, controlled trial was conducted in 10 Kaiser Permanente Colorado clinics. Overall, 348 patients with BP above recommended levels were randomized to the HBPM (n=175) or UC (n=173) groups. There were no statistically significant differences in baseline characteristics between the groups; however, there was a trend toward a higher baseline BP for the HBPM group compared with the UC group (148.8 versus 145.5 mm Hg for systolic BP; 89.6 versus 88.0 mm Hg for diastolic BP). At 6 months, the proportion of patients achieving BP goal was significantly higher in the HBPM group (54.1%) than in the UC group (35.4%; P<0.001). Compared with the UC group, the HBPM group experienced a −12.4-mm Hg larger (95% confidence interval, −16.3 to −8.6) reduction in systolic BP and a −5.7-mm Hg larger (95% confidence interval, −7.8 to −3.6) reduction in diastolic BP. The impact of the intervention on BP reduction was even larger for the subgroup of patients with diabetes mellitus or chronic kidney disease. The HBPM group had more e-mail and telephone contacts and greater medication regimen intensification. The proportion of patients reporting high satisfaction with hypertension care was significantly greater in the HBPM group (58%) than in the UC group (42%), P<0.001. Conclusions—A pharmacist-led, Heart360-supported, home BP monitoring intervention led to greater BP reductions, superior BP control, and higher patient satisfaction than UC. Clinical Trial Registration—URL: http://www.clinicaltrials.gov/ct2/show/NCT01162759. Unique identifier: NCT01162759.

Implications of the Failure to Identify High-Risk Electrocardiogram Findings for the Quality of Care of Patients With Acute Myocardial Infarction Results of the Emergency Department Quality in Myocardial Infarction (EDQMI) Study

Background— The impact of misinterpretation of the ECG in patients with acute myocardial infarction (AMI) in the emergency department (ED) setting is not well known. Our goal was to assess the prevalence of the failure to identify high-risk ECG findings in ED patients with AMI and to determine whether this failure is associated with lower-quality care. Methods and Results— In a retrospective cohort study of consecutive patients presenting to 5 EDs in California and Colorado from July 1, 2000, through June 30, 2002, with confirmed AMI (n=1684), we determined the frequency of the failure by the treating provider to identify significant ST-segment depressions, ST-segment elevations, or T-wave inversions on the presenting ECG. In multivariable models, we assessed the relationship between missed high-risk ECG findings and evidence-based therapy in the ED after adjustment for patient characteristics and site of care. High-risk ECG findings were not documented in 201 patients (12%). The failure to identify high-risk findings was independently associated with a higher odds of not receiving treatment among ideal candidates for aspirin (odds ratio [OR], 2.13; 95% confidence interval [CI], 1.51 to 2.94), β-blockers (OR, 1.85; 95% CI, 1.14 to 3.03), and reperfusion therapy (OR, 7.69; 95% CI, 3.57 to 16.67). Among patients with missed high-risk ECG findings, in-hospital mortality was 7.9% compared with 4.9% among those without missed findings (P=0.1). Conclusions— The failure to identify high-risk ECG findings in patients with AMI results in lower-quality care in the ED. Systematic processes to improve ECG interpretation may have important implications for patient treatment and outcomes.

Randomized trial to improve laboratory safety monitoring of ongoing drug therapy in ambulatory patients.

Study Objective. To determine whether an electronic tool effectively increases the percentage of patients receiving laboratory monitoring during ongoing drug therapy.

Work-related Exacerbation of Asthma

Abstract Adults with asthma who had been enrolled in an HMO for at least a year were requested to complete a questionnaire about their health status. Approximately 25% of the 1,461 participants responded positively to “Does your current work environment make your asthma worse?” and were classified as having workplace exacerbation of asthma. Those with workplace exacerbation were more likely to have never attended college, be current or former smokers, have a history of other respiratory diseases, have missed work or usual activities at least one day in the past four weeks, and report their asthma was moderate, severe, or very severe. Percentages with workplace exacerbation of asthma were highest for mining and construction (36%), wholesale and retail trade (33%), and public administration (33%), and lowest for educational services (22%), finance, insurance, and real estate (22%), and non-medical and non-educational services (18%). Future studies are needed for objective validation of self-reported workplace exacerbation, and to follow subjects prospectively to clarify the temporal sequence of workplace exacerbation and asthma severity, and how other respiratory conditions and smoking might contribute to work-related worsening of asthma.

Blood Pressure Trajectories and Associations With Treatment Intensification, Medication Adherence, and Outcomes Among Newly Diagnosed Coronary Artery Disease Patients

Background— Blood pressure (BP) control among coronary artery disease patients remains suboptimal in clinical practice, potentially due to gaps in treatment intensification and medication adherence. However, longitudinal studies evaluating these relationships and outcomes are limited. Methods and Results— We assessed BP trajectories among health maintenance organization patients with hypertension and incident coronary artery disease. BP trajectories were modeled over the year after coronary artery disease diagnosis, stratified by target BP goal. Treatment intensification (increase in BP therapies in the setting of an elevated BP), medication adherence (percentage of days covered with BP therapies), and outcomes (all-cause mortality, myocardial infarction, and revascularization) were evaluated in multivariable models: 9569 patients had a <140/90 mm Hg BP target and 12 861 had a <130/80 mm Hg BP target. Within each group, 4 trajectories were identified: good, borderline, improved, and poor control. After adjustment, increasing BP treatment intensity was significantly associated with better BP trajectories in both groups. Medication adherence had inconsistent effects. There were no significant differences in combined outcomes by BP trajectory, but among the diabetes and renal disease cohort, borderline control patients were less likely to have myocardial infarction (odds ratio, 0.61; 95% confidence interval, 0.40–0.93), and good control patients were less likely to have myocardial infarction (odds ratio, 0.53; 95% confidence interval, 0.34–0.84) or a revascularization procedure (odds ratio, 0.66; 95% confidence interval, 0.47–0.93) compared with poor control patients. Conclusions— In this health maintenance organization population, treatment intensification but not medication adherence significantly affects BP trajectories in the year after coronary artery disease diagnosis. Better BP trajectories are associated with lower rates of myocardial infarction and revascularization.

Missed opportunities for reperfusion therapy for ST-segment elevation myocardial infarction: Results of the Emergency Department Quality in Myocardial Infarction (EDQMI) study

BACKGROUND Although it is known that reperfusion therapy for ST-elevation myocardial infarction (STEMI) is underused, the reasons for the failure to provide this potentially life-saving treatment are not well described. METHODS In a cohort of 2215 consecutive patients presenting with acute myocardial infarction to 5 emergency departments in Colorado and California between 2000 and 2002, patients with ischemic symptoms and ST-segment elevation on electrocardiogram without documented guideline-based contraindications to therapy were identified as eligible reperfusion candidates. Multivariable logistic models were constructed to identify factors associated with the failure to receive reperfusion. The emergency department records of patients not receiving reperfusion were reviewed to categorize the reasons therapy was not provided. RESULTS Of 460 eligible patients, 102 (22%) did not receive reperfusion therapy. Patient factors associated with failure to receive reperfusion therapy included older age, peripheral vascular disease, and absence of chest pain; patients seen by both resident and attending physicians were more likely to receive treatment than those seen by an attending alone. In cases where reperfusion was not provided, ST-segment elevation was not identified in 34% (n = 35), left bundle-branch block was not considered as an indication in 13% (n = 13), there was documentation of a reason for withholding therapy not supported by guidelines in 34% (n = 35), and there was no documentation of reasons for withholding reperfusion in 19% (n = 19). CONCLUSIONS Initiatives to improve electrocardiogram interpretation and evidence-based patient selection may reduce gaps in the delivery of reperfusion therapy to eligible candidates and thereby potentially improve STEMI outcomes.

Association of longitudinal measures of hemoglobin and outcomes after hospitalization for heart failure

BACKGROUND Cross-sectional assessments of hemoglobin (Hb) are associated with mortality in patients with heart failure (HF). Our objectives were to characterize patterns of change in Hb over time in patients with HF and to evaluate the relationship between longitudinal measures of Hb and adverse outcomes. METHODS The study included 2,478 patients with a primary discharge diagnosis of HF from January 2001 to December 2006. Outcomes included time to death and time to death or HF hospitalization. The association between baseline Hb and outcomes was evaluated using multivariable Cox regression. The longitudinal association was evaluated using a time-dependent Hb predictor variable and using anemia trajectory groups. RESULTS For a median of 475 days, baseline Hb was associated with a trend toward increased mortality (hazard ratio [HR] 1.02, 95% CI 0.99-1.06 per g/dL decline). With a time-dependent approach, the magnitude of the association was greater (HR 1.35, 95% CI 1.30-1.39 per g/dL decline). In trajectory analysis, 35% of the cohort had variable patterns of anemia. Persistently low Hb (HR 1.65, 95% CI 1.27-2.14) and a progressive decline in Hb (HR 1.54, 95% CI 1.16-2.05) were associated with increased mortality risk. Patients with recovery of anemia had similar outcomes as those patients who are persistently nonanemic. Results were similar for the composite of death or HF hospitalization. CONCLUSIONS Variability in Hb over time is common in patients with HF, and declining Hb is associated with a poor prognosis. Longitudinal characterization of Hb levels has greater prognostic significance than a single measurement. Systematic surveillance of Hb levels may help identify high-risk patients with heart failure.

Adherence to CDC STD guideline recommendations for the treatment of Chlamydia trachomatis infection in two managed care organizations.

Background The extent of adherence to the Centers for Disease Control and Prevention (CDC) STD guidelines by clinicians practicing in managed care settings is unknown. Goal The goal was to assess adherence to the CDC guideline recommendations for the treatment of genital chlamydial infection, by clinicians at two group model managed care organizations. Design Retrospective cohort study of men and women with laboratory-confirmed chlamydial infection. Patients were members of either the Kaiser Permanente Foundation Health Plan of Colorado or HealthPartners of Minneapolis/St. Paul who had tested positive for cervical or urethral chlamydial infection during the period from January 1, 1998, through June 30, 1999. Results During the study period, 1078 patients with positive tests for genital Chlamydia trachomatis were identified. More than 97% of men and nonpregnant women and more than 98% of pregnant women were prescribed treatment, consistent with current CDC guidelines. Conclusion Adherence to CDC-recommended therapy was high for patients with genital chlamydial infections at these two managed care organizations.