The objectives of this study were to determine concordance of emergency department (ED) management of acute myocardial infarction (AMI) with guideline recommendations and to identify ED and patient characteristics predictive of higher guideline concordance.
The authors conducted a chart review study of ED AMI care as part of the National Emergency Department Safety Study (NEDSS). Using a primary hospital discharge diagnosis of AMI (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM], codes 410.XX), a random sample of ED visits for AMI in 58 urban EDs across 20 U.S. states between 2003 and 2006 were identified. Concordance with American College of Cardiology/American Heart Association (ACC/AHA) guideline recommendations was evaluated using five individual quality measures and a composite concordance score. Concordance scores were calculated as the percentage of eligible patients who received guidelines-recommended care. These percentage scores were rescaled from 0 to 100, with 100 indicating perfect concordance.
The cohort consisted of 3,819 subjects; their median age was 65 years, and 62% were men. The mean (± standard deviation [SD]) ED composite concordance score was 61 ± 8), with a broad range of values (42 to 84). Except for aspirin use (mean concordance, 82), ED concordance scores were low (beta-blocker use, 56; timely electrocardiogram [ECG], 41; timely fibrinolytic therapy, 26; timely ED disposition for primary percutaneous coronary intervention [PCI] candidates, 43). In multivariable analyses, older age (beta-coefficient per 10-year increase, −1.5; 95% confidence interval [CI] = −2.4 to −0.5) and southern EDs (beta-coefficient, −5.2; 95% CI = −9.6 to −0.9) were associated with lower guideline concordance, whereas ST-segment elevation on initial ED ECG was associated with higher guideline concordance (beta-coefficient, 3.6; 95% CI = 1.5 to 5.7).
Overall ED concordance with guideline-recommended processes of care was low to moderate. Emergency physicians should continue to work with other stakeholders in AMI care, such as emergency medical services (EMS) and cardiologists, to develop strategies to improve care processes.
acute myocardial infarction; emergency department; guidelines; quality of care
Workplace violence is a concerning issue. Healthcare workers represent a significant portion of the victims, especially those who work in the emergency department (ED). The objective of this study was to examine ED workplace violence and staff perceptions of physical safety.
Data were obtained from the National Emergency Department Safety Study (NEDSS), which surveyed staff across 69 U.S. EDs including physicians, residents, nurses, nurse practitioners, and physician assistants. The authors also conducted surveys of key informants (one from each site) including ED chairs, medical directors, nurse managers, and administrators. The main outcome measures included physical attacks against staff, frequency of guns or knives in the ED, and staff perceptions of physical safety.
A total of 5,695 staff surveys were distributed, and 3,518 surveys from 65 sites were included in the final analysis. One-fourth of surveyed ED staff reported feeling safe sometimes, rarely, or never. Key informants at the sampled EDs reported a total of 3,461 physical attacks (median of 11 attacks per ED) over the 5-year period. Key informants at 20% of EDs reported that guns or knives were brought to the ED on a daily or weekly basis. In multivariate analysis, nurses were less likely to feel safe “most of the time” or “always” when compared to other surveyed staff.
This study showed that violence and weapons in the ED are common, and nurses were less likely to feel safe than other ED staff.
emergency department; violence; weapons; safety; workplace
Trials comparing hypertension monotherapies have found either no difference or modest differences in blood pressure (BP) and cardiovascular (CV) events. However, no trial has assessed the comparative effectiveness of second-line therapy in patients whose BP was not controlled on a thiazide diuretic.
Methods and Results
Observational study conducted using a hypertension registry of adults enrolled in 3 large integrated healthcare delivery systems from 2002-2007. Patients newly started on thiazide monotherapy whose BP remained uncontrolled were observed following addition of either an ACE inhibitor or beta-blocker for subsequent BP control and CV events. Patients for whom either add-on drug was indicated or contraindicated were excluded.
After adjustment for patient characteristics and study year, BP control during the subsequent 6-18 months was comparable for the two agents (70.5% ACE, 69.0% Beta-blockers; p=0.09). Rates of incident myocardial infarction (HR 1.05, 95% CI 0.69 – 1.58) and stroke (1.01. 95% CI 0.68 – 1.52) were also similar for the ACE inhibitor and beta-blocker groups during an average of 2. 3 years of follow-up. There were also no differences in heart failure or renal function.
ACE inhibitors and beta-blockers are equally effective in lowering blood pressure and preventing cardiovascular events for patients whose blood pressure is not controlled on a thiazide diuretic alone and who have no compelling indication for a specific second-line agent.
hypertension; comparative effectiveness; diuretics; cardiovascular diseases
Little is known about the quality of acute asthma care in the emergency department (ED).
We sought to determine the concordance of ED management of acute asthma with National Institutes of Health asthma guidelines, to identify ED characteristics predictive of higher guideline concordance, and to assess whether guideline concordance was associated with hospital admission.
We conducted a retrospective chart review study of acute asthma as part of the National Emergency Department Safety Study. Using a principal diagnosis of asthma, we identified ED visits for acute asthma in 63 urban EDs in 23 US states between 2003 and 2006. Concordance with guideline recommendations was evaluated by using item-by-item quality measures and composite concordance scores both at the patient and ED level. These scores ranged from 0 to 100, with 100 indicating perfect concordance.
The cohort consisted of 4,053 subjects; their median age was 34 years, and 64% were women. The overall patient guideline concordance score was 67 (interquartile range, 63–83), and the ED concordance score was 71 (SD, 7). Multivariable analysis showed southern EDs were associated with lower ED concordance scores (β-coefficient, −8.2; 95% CI, −13.8 to −2.7) compared with northeastern EDs. After adjustment for the severity on ED presentation, patients who received all recommended treatments had a 46% reduction in the risk of hospital admission compared with others.
Concordance with treatment recommendations in the National Institutes of Health asthma guidelines was moderate. Significant variations in ED quality of asthma care were found, and geographic differences existed. Greater concordance with guideline-recommended treatments might reduce hospitalizations.
Acute asthma; emergency department; guidelines; quality of care
In response to the short-term negative inotropic and chronotropic effects of β-blockers, heart failure (HF) guidelines recommend initiating β-blockers at low dose with gradual uptitration as tolerated to doses used in clinical trials. However, patterns and safety of β-blocker intensification in routine practice are poorly described.
We described β-blocker intensification among Kaiser Colorado enrollees with a primary discharge diagnosis of HF between 2001–2009. We then assessed β-blocker intensification in the 30 days prior to first hospital readmission for cases compared to the same time period following index hospitalization for non-rehospitalized matched controls. In separate analysis of the subgroup initiated on β-blocker after index hospital discharge, we compared adjusted rates of 30-day hospitalization following initiation of high versus low dose β-blocker.
Among 3,227 patients, median age was 76 years and 37% had ejection fraction ≤40% (LVSD). During a median follow up of 669 days, 14% were never on β-blocker, 21% were initiated on β-blocker, 43% were discharged on β-blocker but never uptitrated, and 22% had discharge β-blocker uptitrated; 63% were readmitted and 49% died. β-blocker intensification occurred in the 30 days preceding readmission for 39 of 1,674 (2.3%) readmitted cases compared to 27 (1.6%) of matched controls (adjusted OR 1.36, 95% CI 0.81-2.27). Among patients initiated on therapy, readmission over the subsequent 30 days occurred in 6 of 155 (3.9%) prescribed high dose and 9 of 513 (1.8%) prescribed low dose β-blocker (adjusted OR 3.10, 95% CI 1.02-9.40). For the subgroup with LVSD, findings were not significantly different.
While β-blockers were intensified in nearly half of patients following hospital discharge and high starting dose was associated with increased readmission risk, the prevailing finding was that readmission events were rarely preceded by β-blocker intensification. These data suggest that β-blocker intensification is not a major precipitant of hospitalization, provided recommended dosing is followed.
Heart failure; Pharmacology; Beta-blocker (β-blocker); Safety; Outcomes
Although exercise treadmill testing (ETT) is known to be less sensitive and specific for diagnosis of coronary disease in women, little is known about gender differences in the prognostic importance of ETT variables.
We studied9569 consecutive patients (46.8% women) referred for ETT between July 2001- June 2004 in a community-based system. We assessed the association between ETT variables (exercise capacity, symptoms, ST-segment deviations, heart rate recovery, and chronotropic response) and time to all-cause death and myocardial infarction adjusting for patient and stress test characteristics. Models were stratified by gender to determine the relationship between ETT variables and outcomes.
In the entire population, exercise capacity and heart rate recovery were significantly associated with all-cause death, whereas, exercise capacity, chest pain and ST-segment deviations were significantly associated with subsequent MI. The relationship between ETT variables and outcomes were similar between men and women except for abnormal exercise capacity, which was had a significantly stronger association with death in men (men: HR = 2.89, 95% CI 1.89–4.44; women: HR = 0.99, 95% CI 0.52–1.93; interaction
While many traditional ETT variables had similar prognostic value in both men and women, exercise capacity was more prognostically important in men and chronotropic incompetence was more important in women. Future studies should confirm these findings in additional populations.
gender differences; stress testing; prognosis
Despite gender neutral guidelines, prior studies suggest that women have lower rates of hypertension control and these differences may vary with age. Accordingly, we compared rates of hypertension control between women and men as a function of age.
Within 3 integrated healthcare systems in the Cardiovascular Research Network, we studied all patients seen from 2001–2007 with incident hypertension. Within 1-year of cohort entry, patient’s hypertension was categorized as: 1) controlled based upon achieving guideline-recommended BP levels, 2) recognized if hypertension was diagnosed or a hypertension medication dispensed, and 3) treated based on hypertension medications dispensed. Multivariable logistic regression models assessed the association between gender and 1-year hypertension outcomes, adjusted for patient characteristics.
Among the 152,561 patients with incident hypertension, 55.6% were women. Compared to men, women were older, had more kidney disease and more blood pressure measures during follow-up. Overall, men tended to have lower rates of hypertension control compared to women (41.2% vs. 45.7%, adjusted OR 0.93, 96% CI 0.91–0.95). A significant gender by age interaction was found with men aged 18–49 having 17% lower odds of hypertension control and men aged ≥ 65 having 12% higher odds of hypertension control compared to women of similar ages (p<0.001).
In this incident hypertension cohort, younger men and older women had lower rates of hypertension control compared to similarly aged peers. Future studies should investigate why gender differences vary by age in order to plan appropriate means of improving hypertension management regardless of gender or age.
Hypertension; gender; aging; treatment disparities
Younger women use both internal medicine and OBGYN clinics as primary sources of health care. However, the role of OBGYNs in cardiovascular disease (CVD) prevention is largely unexplored. The objective of this study is to examine rates of hypertension recognition in women under 50 who present with elevated blood pressures in family practice and internal medicine (Medicine) and OBGYN clinics, and to compare these rates across clinic type. The study’s population consisted of 34,627 non-pregnant women ages 18–49 with new-onset hypertension (defined as two consecutive visits with elevated blood pressures of SBP ≥140mmHg or DBP ≥90 mmHg with no prior hypertension history) from 2002–2006. Multivariate logistic regressions predicting the clinical recognition of hypertension (a recorded diagnosis of hypertension and/or an antihypertensive prescription by any provider within one year of the second elevated blood pressure) assessed the association between hypertension recognition and the clinic where the second elevated blood pressure was recorded. Analysis showed that hypertension was recognized in less than 33% of women with new-onset hypertension. Women whose second consecutive elevated blood pressure was recorded in OBGYN were less likely to be recognized as having hypertension within 12 months by any provider compared to women whose second consecutive elevated blood pressure was recorded in Medicine (OR=0.51;95% CI=(0.48, 0.54)). This study suggests that further attention be paid to identifying and treating CVD risk factors in women under 50 presenting in both Medicine and OBGYN, and that improved coordination across care settings has the potential to improve CVD prevention in young women.
Hypertension; gender; CVD prevention; primary care; OBGYN
An increasing number of parents are choosing to decline immunizations for their children. This study examined the association between the parental decision to decline pneumococcal conjugate (PCV7) vaccinations and the risk of hospitalization due to pneumococcal disease or lobar pneumonia in children.
We conducted a case-control study nested within a cohort of children enrolled in the Kaiser Permanente Colorado (KPCO) health plan between 2004 and 2009. Each child hospitalized with pneumococcal disease or lobar pneumonia (n=106) was matched to 4 randomly selected controls (n=401). Cases were matched to controls by age, sex, high-risk status, calendar time, and length of enrollment in KPCO. Disease status and parental vaccination decisions were validated with medical record review. Cases and controls were classified as vaccine decliners or vaccine acceptors.
Among 106 cases, there were 6 (6%) PCV7 vaccine decliners; among 401 controls, there were 4 (1%) vaccine decliners. Children of parents who declined PCV7 immunization were 6.5 times (OR=6.5; 95% CI=1.7, 24.5) more likely to be hospitalized for invasive pneumococcal disease or lobar pneumonia than vaccinated children.
Parental decline of pneumococcal vaccination apparently increases the risk for hospitalization due to pneumococcal disease or lobar pneumonia in children. Providers can use this information when helping parents weigh the benefits and risks of immunizing their children.
case control study; pneumococcal vaccine; vaccine decliner; lobar pneumonia; invasive pneumococcal disease
Achieving full benefits of blood pressure control in populations requires prompt recognition of previously undetected hypertension. In 2003, JNC VII provided definitions of hypertension and recommended that single elevated readings be confirmed within 1–2 months. We sought to determine whether the time required to confirm and recognize (i.e., diagnose and/or treat) new-onset hypertension decreased from 2002 to 2006 for adult members of two large integrated health care delivery systems, Kaiser Permanente Northern California and Colorado. Using electronically stored office blood pressure readings, physician diagnoses and pharmacy prescriptions, we identified 200,587 patients with new-onset hypertension (2002–2006) marked by two consecutive elevated blood pressure readings in previously undiagnosed, untreated members.
Mean confirmation intervals (time from the first to second consecutive elevated reading) declined steadily from 103 to 89 days during this period. For persons recognized within 12 months following confirmation, the mean interval to recognition declined from 78 to 61 days. However, only 33% of individuals were recognized within 12 months. One third were never recognized during observed follow-up. For these patients, most subsequent blood pressure recordings were not elevated. Higher initial blood pressure levels, history of previous cardiovascular disease, and older age were associated with shorter times to recognition.
Times to confirmation and recognition of new-onset hypertension have become shorter in recent years, especially for patients with higher cardiovascular disease risk. Variability in office-based blood pressure readings suggests that further improvements in recognition and treatment may be achieved with more specific automated approaches to identifying hypertension.
hypertension; electronic health records; registries, early detection; screening
Blood pressure (BP) control among coronary artery disease (CAD) patients remains sub-optimal 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 (HMO) patients with hypertension and incident CAD. BP trajectories were modeled over the year following CAD 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, MI, and revascularization) were evaluated in multivariable models. 9,569 patients had a <140/90 BP target and 12,861 had a <130/80 BP target. Within each group, four 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 an MI (OR 0.61, 95% 0.40, 0.93), and good control patients were less likely to have an MI (OR 0.53, 95% CI 0.34, 0.84) or a revascularization procedure (OR 0.66, 95% CI 0.47, 0.93) compared to poor control patients.
In this HMO population, treatment intensification, but not medication adherence, significantly affects BP trajectories in the year following CAD diagnosis. Better BP trajectories are associated with lower rates of MI and revascularization.
hypertension; epidemiology; health services research; myocardial infarction; mortality
Patients with diabetes and ischemic heart disease (IHD) are at high risk for adverse cardiac outcomes. Clinical practice guidelines recommend multiple cardioprotective medications to reduce recurrent events. We evaluated the association between cardioprotective medication adherence and mortality among patients with diabetes and IHD.
In a retrospective cohort study of 3,998 patients with diabetes and IHD, we evaluated use of ACE inhibitors or angiotensin receptor blockers, β-blockers, and statin medications. Receipt of cardioprotective medications was based on filled prescriptions. Medication adherence was calculated as the proportion of days covered (PDC) for filled prescriptions. The primary outcome of interest was all-cause mortality.
The majority of patients (92.8%) received at least 1 cardioprotective medication. Patients receiving any medications had lower unadjusted mortality rates compared to patients not receiving any medications (7.9% vs. 11.5%; p = 0.03). In multivariable analysis, receipt of any cardioprotective medication remained associated with lower all-cause mortality (OR 0.65; 95% CI 0.43–0.99). Among patients receiving cardioprotective medications, the majority (80.3%) were adherent (PDC ≥ 0.80). Adherent patients had lower unadjusted mortality rates (6.7% vs. 12.1%; p < 0.01). In multivariable analysis, medication adherence remained associated with lower all-cause mortality (OR 0.52; 95% CI 0.39–0.69) compared to non-adherence. In contrast, there was no mortality difference between patients receiving cardioprotective medications who were non-adherent compared to patients not receiving any medications (OR 1.01; 95% CI 0.64–1.61).
In conclusion, medication adherence is associated with improved outcomes among patients with diabetes and IHD. Quality improvement interventions are needed to increase medication adherence in order for patients to maximize the benefit of cardioprotective medications.
Diabetes is an important predictor of mortality patients with ACS. However, little is known about the association between diabetes and health status after ACS. The objective of this study was to examine the association between diabetes and patients' health status outcomes one year after an acute coronary syndrome (ACS).
This was a prospective cohort study of patients hospitalized with ACS. Patients were evaluated at baseline and one year with the Seattle Angina Questionnaire (SAQ). Socio-demographic and clinical characteristics were ascertained during index ACS hospitalization. One year SAQ Angina Frequency, Physical Limitation, and Health-Related Quality of Life (HRQoL) scales were the primary outcomes of the study.
Of 1199 patients, 326 (37%) had diabetes. Patients with diabetes were more likely to present with unstable angina (52% vs. 40%; p < 0.001), less likely to present with STEMI (20% vs. 31%; p < 0.001), and less likely to undergo coronary angiography (68% vs. 82%; p < 0.001). In multivariable analyses, the presence of diabetes was associated with significantly more angina (OR 1.36; 95% CI 1.01–1.38), cardiac-related physical limitation (OR 1.94; 95% CI 1.57–3.24) and HRQoL deficits (OR 1.43; 95% CI 1.01–2.04) at one year.
Diabetes is associated with more angina, worse physical limitation, and worse HRQoL one year after an ACS. Future studies should assess whether health status outcomes of patients with diabetes could be improved through more aggressive ACS treatment or post-discharge surveillance and angina management.
Although many studies have identified patient characteristics or chronic diseases associated with medication adherence, the clinical utility of such predictors has rarely been assessed. We attempted to develop clinical prediction rules for adherence with antihypertensive medications in two health care delivery systems.
Methods and Results
Retrospective cohort studies of hypertension registries in an inner-city health care delivery system (N = 17176) and a health maintenance organization (N = 94297) in Denver, Colorado. Adherence was defined by acquisition of 80% or more of antihypertensive medications.
A multivariable model in the inner-city system found that adherent patients (36.3% of the total) were more likely than non-adherent patients to be older, white, married, and acculturated in US society, to have diabetes or cerebrovascular disease, not to abuse alcohol or controlled substances, and to be prescribed less than three antihypertensive medications. Although statistically significant, all multivariate odds ratios were 1.7 or less, and the model did not accurately discriminate adherent from non-adherent patients (C-statistic = 0.606). In the health maintenance organization, where 72.1% of patients were adherent, significant but weak associations existed between adherence and older age, white race, the lack of alcohol abuse, and fewer antihypertensive medications. The multivariate model again failed to accurately discriminate adherent from non-adherent individuals (C-statistic = 0.576).
Although certain socio-demographic characteristics or clinical diagnoses are statistically associated with adherence to refills of antihypertensive medications, a combination of these characteristics is not sufficiently accurate to allow clinicians to predict whether their patients will be adherent with treatment.
drugs; hypertension; prevention
Hyperlipidemia and hypertension are well-established risk factors for recurrent cardiovascular events among patients with ischemic heart disease (IHD). Despite national recommendations, concordance with guidelines for LDL cholesterol and blood pressure remains inadequate. The objectives of this study were to 1) determine concordance rates with LDL cholesterol and BP recommendations; and 2) identify patient factors, processes and structures of care associated with guideline concordance among VA IHD patients.
This was a cross sectional study of veterans with IHD from 8 VA hospitals. Outcomes were concordance with LDL guideline recommendations (LDL<100 mg/dl), and BP recommendations (<140/90 mm Hg). Cumulative logit and hierarchical logistic regression analyses were performed to identify patient factors, processes, and structures of care independently associated with guideline concordance.
Of 14,114 veterans with IHD, 55.7% had hypertension, 71.5% had hyperlipidemia, and 41.6% had both conditions. Guideline concordance for LDL and BP were 38.9% and 53.4%, respectively. However, only 21.9% of the patients achieved both LDL <100 mg/dl and BP <140/90 mm Hg. In multivariable analyses, patient factors including older age and the presence of vascular disease were associated with worse guideline concordance. In contrast, diabetes was associated with better guideline concordance. Several process of care variables, including higher number of outpatient visits, higher number of prescribed medications, and a recent cardiac hospitalization were associated with better guideline concordance. Among structures of care, having on-site cardiology was associated with a trend towards better guideline concordance.
Guideline concordance with secondary prevention measures among IHD patients remains suboptimal. It is hoped that the findings of this study can serve as an impetus for quality improvement efforts to improve upon secondary prevention measures and reduce the morbidity and mortality of patients with known IHD.
Few studies report on the effect of organizational factors facilitating transfer between primary and tertiary care hospitals either within an integrated health care system or outside it. In this paper, we report on the relationship between degree of clinical integration of cardiology services and transfer rates of acute coronary syndrome (ACS) patients from primary to tertiary hospitals within and outside the Veterans Health Administration (VHA) system.
Prospective cohort study. Transfer rates were obtained for all patients with ACS diagnoses admitted to 12 primary VHA hospitals between 1998 and 1999. Binary variables measuring clinical integration were constructed for each primary VHA hospital reflecting: presence of on-site VHA cardiologist; referral coordinator at the associated tertiary VHA hospital; and/or referral coordinator at the primary VHA hospital. We assessed the association between the integration variables and overall transfer from primary to tertiary hospitals, using random effects logistic regression, controlling for clustering at two levels and adjusting for patient characteristics.
Three of twelve hospitals had a VHA cardiologist on site, six had a referral coordinator at the tertiary VHA hospital, and four had a referral coordinator at the primary hospital. Presence of a VHA staff cardiologist on site and a referral coordinator at the tertiary VHA hospital decreased the likelihood of any transfer (OR 0.45, 95% CI 0.27–0.77, and 0.46, p = 0.002, CI 0.27–0.78). Conversely, having a referral coordinator at the primary VHA hospital increased the likelihood of transfer (OR 6.28, CI 2.92–13.48).
Elements of clinical integration are associated with transfer, an important process in the care of ACS patients. In promoting optimal patient care, clinical integration factors should be considered in addition to patient characteristics.
The objective of this study was to demonstrate the use of the Heckman two-step method to assess and correct for bias due to missing health related quality of life (HRQL) surveys in a clinical study of acute coronary syndrome (ACS) patients.
We analyzed data from 2,733 veterans with a confirmed diagnosis of acute coronary syndromes (ACS), including either acute myocardial infarction or unstable angina. HRQL outcomes were assessed by the Short-Form 36 (SF-36) health status survey which was mailed to all patients who were alive 7 months following ACS discharge. We created multivariable models of 7-month post-ACS physical and mental health status using data only from the 1,660 survey respondents. Then, using the Heckman method, we modeled survey non-response and incorporated this into our initial models to assess and correct for potential bias. We used logistic and ordinary least squares regression to estimate the multivariable selection models.
We found that our model of 7-month mental health status was biased due to survey non-response, while the model for physical health status was not. A history of alcohol or substance abuse was no longer significantly associated with mental health status after controlling for bias due to non-response. Furthermore, the magnitude of the parameter estimates for several of the other predictor variables in the MCS model changed after accounting for bias due to survey non-response.
Recognition and correction of bias due to survey non-response changed the factors that we concluded were associated with HRQL seven months following hospital admission for ACS as well as the magnitude of some associations. We conclude that the Heckman two-step method may be a valuable tool in the assessment and correction of selection bias in clinical studies of HRQL.
Selection bias; cardiovascular disease; health-related quality of life
The objective of our study was to examine cardiologists’ and organizational leaders’ interest in clinical trial participation and perceived barriers and facilitators to participation within ten diverse non-profit healthcare delivery systems. Trials play a pivotal role in advancing knowledge about the safety and efficacy of cardiovascular interventions and tests. Although cardiovascular trials successfully enroll patients, recruitment challenges persist. Community-based health systems could be an important source of participants and investigators, but little is known about community cardiologists’ experiences with trials.
We interviewed 25 cardiology and administrative leaders and mailed questionnaires to all 280 cardiologists at 10 U.S. healthcare organizations.
The survey received a 73% response rate. While 60% of respondents had not participated in any trials in the past year, nearly 75% wanted greater participation. Cardiologists reported positive attitudes toward trial participation; more than half agreed that trials were their first choice of therapy for patients, if available. Almost all leaders described their organizations as valuing research but not necessarily trials. Major barriers to participation were lack of physician time and insufficient skilled research nurses.
Cardiologists have considerable interest in trial participation. Major obstacles to increased participation are lack of time and effective infrastructure to support trials. These results suggest that community-based health systems are a rich source for cardiovascular research but additional funding and infrastructure are needed to leverage this resource.
clinical trials; clinical trials recruitment; barriers to clinical trial participation; clinician participation in clinical trials
OBJECTIVES— To assess the association between impaired chronotropic response (CR) and adverse events among patients with diabetes referred for exercise treadmill testing (ETT).
RESEARCH DESIGN AND METHODS— Impaired CR was defined as achievement of <80% of a patient's heart rate reserve. We used multivariable Cox proportional hazards regression to assess the independent association between impaired CR and adverse outcomes adjusting for demographics, comorbidities, and treadmill variables including the Duke Treadmill score.
RESULTS— Of 1,341 patients with diabetes, 35.7% (n = 479) demonstrated impaired CR during ETT. Patients with impaired CR were at increased risk of all-cause mortality, myocardial infarction, or coronary revascularization procedures. In multivariable analyses, impaired CR remained significantly associated with adverse outcomes (hazard ratio 1.53 [95% CI 1.10–2.14]).
CONCLUSIONS— Among patients with diabetes, impaired CR is common during ETT and is associated with adverse outcomes. Impaired CR can be used as another noninvasive tool to risk-stratify patients with diabetes following ETT.
Fibrinolytic therapy remains the most common reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), particularly in smaller centers. Previous studies evaluated the relationship between time to treatment and outcomes when few patients were treated within 30 minutes of hospital arrival and many did not receive modern adjunctive medications. To quantify the impact of delay in door-to-needle time on mortality in a recent and representative cohort of STEMI patients, we analyzed a cohort of 62,470 STEMI patients treated with fibrinolytic therapy at 973 hospitals that participated in the National Registry of Myocardial Infarction from 1999–2002. We employed hierarchical models to evaluate the independent effect of door-to-needle time on in-hospital mortality. In-hospital mortality was lower with shorter door-to-needle times (2.9% for ≤30 minutes, 4.1% for 31–45 minutes, and 6.2% for >45 minutes; p< 0.001 for trend). Compared with those experiencing door-to-needle times ≤30 minutes, the adjusted odd ratios (OR) of dying were 1.17 (confidence interval (CI) 1.04–1.31) and 1.37 (CI 1.23–1.52; p for trend <0.001) for those patients with door-to-needle times of 31–45 minutes and >45 minutes, respectively. This relationship was particularly pronounced in those presenting within 1 hour of symptom onset to presentation time [OR: 1.25 (CI 1.01–1.54) and 1.54 (CI 1.27–1.87) respectively; p for trend <0.001]. In conclusion, timely administration of fibrinolytic therapy continues to significantly impact mortality in the modern era, particularly in patients presenting early after symptom onset.
myocardial infarction; mortality; reperfusion; fibrinolysis; thrombolysis
Patient satisfaction is increasingly recognized as a quality indicator and important outcome of care. Little is known about the clinical factors associated with satisfaction after myocardial infarction (MI).
To assess the hypothesis that angina after MI is independently associated with lower treatment satisfaction.
We evaluated 1,815 MI patients from 19 U.S. centers. Angina was measured at 1 and 6 months after MI using the Seattle Angina Questionnaire (SAQ). Treatment satisfaction was measured using the SAQ at 6 months. Multivariable regression was used to evaluate the association between 1- and 6-month angina and 6-month treatment satisfaction.
Sixty-two percent of patients had no angina at 1 and 6 months after MI, 14% had transient angina (angina at 1 month, no angina at 6 months), 11% had new angina (angina at 6 months only), and 13% had persistent angina (angina at both 1 and 6 months). In unadjusted analysis, the presence of angina at 6 months, whether new or persistent, was associated with lower treatment satisfaction (p < 0.001). In multivariable analysis, angina was associated with lower treatment satisfaction [relative risk (RR) 2.9, 95%confidence interval (CI) 2.4–3.5 patients with new angina; RR 3.1, 95%CI 2.5–3.9 patients with persistent angina, vs patients with no angina].
In conclusion, angina in the 6 months following MI is present in almost 1 in 4 patients and is strongly associated with lower treatment satisfaction. This suggests the importance of angina surveillance and management after MI as a possible target to improve treatment satisfaction and, thereby, quality of care.
angina; treatment satisfaction; myocardial infarction
This study sought to determine whether a computerized tool that alerted pharmacists when pregnant patients were prescribed U.S. Food and Drug Administration pregnancy risk category D or X medications was effective in decreasing dispensings of these medications.
Randomized trial. Pharmacy, diagnostic, and laboratory data were linked to identify pregnant patients prescribed targeted medications. Women (n = 11,100) were randomized to intervention or usual care. Physicians and pharmacists collaborated on the intervention.
The primary outcome was the proportion of pregnant women dispensed a category D or X medication. The secondary outcome was the total number of first dispensings of targeted medications.
A total of 2.9% of intervention (n = 177) and 5.5% of usual care (n = 276) patients were dispensed targeted medications (p < 0.001): 1.8% of intervention (n = 108) and 3.9% of usual care (n = 198) patients were dispensed only category D medication(s); 0.9% of intervention (n = 54) and 1.2% of usual care (n = 58) patients were dispensed only category X medication(s); 0.2% of intervention (n = 15) and 0.4% of usual care (n = 20) patients were dispensed both category D and X medications (p = 0.05). This resulted in intervention patients receiving 238 dispensings of unique targeted medications and usual care patients receiving 361 dispensings of unique targeted medications (p = 0.03). The study was stopped primarily due to 2 false-positive alert types: Misidentification of medications as contraindicated in pregnancy by the pharmacy information system and misidentification of pregnancy related to delayed transfer of diagnosis information.
Coupling data from information systems with knowledge and skills of physicians and pharmacists resulted in improved prescribing safety. Systems limitations contributed to project discontinuation. Linking ambulatory clinical, laboratory, and pharmacy information to provide safety alerts is not sufficient to ensure project success and sustainability.