Kelly M. Strait

Sex Differences in Reperfusion in Young Patients With ST-Segment–Elevation Myocardial Infarction Results From the VIRGO Study

Background— Sex disparities in reperfusion therapy for patients with acute ST-segment–elevation myocardial infarction have been documented. However, little is known about whether these patterns exist in the comparison of young women with men. Methods and Results— We examined sex differences in rates, types of reperfusion therapy, and proportion of patients exceeding American Heart Association reperfusion time guidelines for ST-segment–elevation myocardial infarction in a prospective observational cohort study (2008–2012) of 1465 patients 18 to 55 years of age, as part of the US Variations in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study at 103 hospitals enrolling in a 2:1 ratio of women to men. Of the 1238 patients eligible for reperfusion, women were more likely to be untreated than men (9% versus 4%, P=0.002). There was no difference in reperfusion strategy for the 695 women and 458 men treated. Women were more likely to exceed in-hospital and transfer time guidelines for percutaneous coronary intervention than men (41% versus 29%; odds ratio, 1.65; 95% confidence interval, 1.27–2.16), more so when transferred (67% versus 44%; odds ratio, 2.63; 95% confidence interval, 1.17–4.07); and more likely to exceed door-to-needle times (67% versus 37%; odds ratio, 2.62; 95% confidence interval, 1.23–2.18). After adjustment for sociodemographic, clinical, and organizational factors, sex remained an important factor in exceeding reperfusion guidelines (odds ratio, 1.72; 95% confidence interval, 1.28–2.33). Conclusions— Young women with ST-segment–elevation myocardial infarction are less likely to receive reperfusion therapy and more likely to have reperfusion delays than similarly aged men. Sex disparities are more pronounced among patients transferred to percutaneous coronary intervention institutions or who received fibrinolytic therapy.

Hospital Variation in the Use of Noninvasive Cardiac Imaging and Its Association With Downstream Testing, Interventions, and Outcomes

IMPORTANCE Current guidelines allow substantial discretion in use of noninvasive cardiac imaging for patients without acute myocardial infarction (AMI) who are being evaluated for ischemia. Imaging use may affect downstream testing and outcomes. OBJECTIVE To characterize hospital variation in use of noninvasive cardiac imaging and the association of imaging use with downstream testing, interventions, and outcomes. DESIGN, SETTING, AND PARTICIPANTS Cross-sectional study of hospitals using 2010 administrative data from Premier, Inc, including patients with suspected ischemia on initial evaluation who were seen in the emergency department, observation unit, or inpatient ward; received at least 1 cardiac biomarker test on day 0 or 1; and had a principal discharge diagnosis for a common cause of chest discomfort, a sign or symptom of cardiac ischemia, and/or a comorbidity associated with coronary disease. We excluded patients with AMI. MAIN OUTCOMES AND MEASURES At each hospital, the proportion of patients who received noninvasive imaging to identify cardiac ischemia and the subsequent rates of admission, coronary angiography, and revascularization procedures. RESULTS We identified 549,078 patients at 224 hospitals. The median (interquartile range) hospital noninvasive imaging rate was 19.8% (10.9%-27.7%); range, 0.2% to 55.7%. Median hospital imaging rates by quartile were Q1, 6.0%; Q2, 15.9%; Q3, 23.5%; Q4, 34.8%. Compared with Q1, Q4 hospitals had higher rates of admission (Q1, 32.1% vs Q4, 40.0%), downstream coronary angiogram (Q1, 1.2% vs Q4, 4.9%), and revascularization procedures (Q1, 0.5% vs Q4, 1.9%). Hospitals in Q4 had a lower yield of revascularization for noninvasive imaging (Q1, 7.6% vs Q4, 5.4%) and for angiograms (Q1, 41.2% vs Q4, 38.8%). P <.001 for all comparisons. Readmission rates to the same hospital for AMI within 2 months were not different by quartiles (P = .51). Approximately 23% of variation in imaging use was attributable to the behavior of individual hospitals. CONCLUSIONS AND RELEVANCE Hospitals vary in their use of noninvasive cardiac imaging in patients with suspected ischemia who do not have AMI. Hospitals with higher imaging rates did not have substantially different rates of therapeutic interventions or lower readmission rates for AMI but were more likely to admit patients and perform angiography.

Sex Differences in Perceived Stress and Early Recovery in Young and Middle-Aged Patients With Acute Myocardial Infarction

Background— Younger age and female sex are both associated with greater mental stress in the general population, but limited data exist on the status of perceived stress in young and middle-aged patients presenting with acute myocardial infarction. Methods and Results— We examined sex difference in stress, contributing factors to this difference, and whether this difference helps explain sex-based disparities in 1-month recovery using data from 3572 patients with acute myocardial infarction (2397 women and 1175 men) 18 to 55 years of age. The average score of the 14-item Perceived Stress Scale at baseline was 23.4 for men and 27.0 for women (P<0.001). Higher stress in women was explained largely by sex differences in comorbidities, physical and mental health status, intrafamily conflict, caregiving demands, and financial hardship. After adjustment for demographic and clinical characteristics, women had worse recovery than men at 1 month after acute myocardial infarction, with mean differences in improvement score between women and men ranging from −0.04 for EuroQol utility index to −3.96 for angina-related quality of life (P<0.05 for all). Further adjustment for baseline stress reduced these sex-based differences in recovery to −0.03 to −3.63, which, however, remained statistically significant (P<0.05 for all). High stress at baseline was associated with significantly worse recovery in angina-specific and overall quality of life, as well as mental health status. The effect of baseline stress on recovery did not vary between men and women. Conclusions— Among young and middle-aged patients, higher stress at baseline is associated with worse recovery in multiple health outcomes after acute myocardial infarction. Women perceive greater psychological stress than men at baseline, which partially explains women’s worse recovery.

Variation Exists in Rates of Admission to Intensive Care Units for Heart Failure Patients Across Hospitals in the United States

Background— Despite increasing attention on reducing relatively costly hospital practices while maintaining the quality of care, few studies have examined how hospitals use the intensive care unit (ICU), a high-cost setting, for patients admitted with heart failure (HF). We characterized hospital patterns of ICU admission for patients with HF and determined their association with the use of ICU-level therapies and patient outcomes. Methods and Results— We identified 166 224 HF discharges from 341 hospitals in the 2009–2010 Premier Perspective database. We excluded hospitals with <25 HF admissions, patients <18 years old, and transfers. We defined ICU as including medical ICU, coronary ICU, and surgical ICU. We calculated the percent of patients admitted directly to an ICU. We compared hospitals in the top quartile (high ICU admission) with the remaining quartiles. The median percentage of ICU admission was 10% (interquartile range, 6%–16%; range, 0%–88%). In top-quartile hospitals, treatments requiring an ICU were used less often; the percentage of ICU days receiving mechanical ventilation was 6% for the top quartile versus 15% for the others; noninvasive positive pressure ventilation, 8% versus 19%; vasopressors and/or inotropes, 9% versus 16%; vasodilators, 6% versus 12%; and any of these interventions, 26% versus 51%. Overall HF in-hospital risk-standardized mortality was similar (3.4% versus 3.5%; P=0.2). Conclusions— ICU admission rates for HF varied markedly across hospitals and lacked association with in-hospital risk-standardized mortality. Greater ICU use correlated with fewer patients receiving ICU interventions. Judicious ICU use could reduce resource consumption without diminishing patient outcomes.

Sharing of clinical trial data among trialists: a cross sectional survey

Objective To investigate clinical trialists’ opinions and experiences of sharing of clinical trial data with investigators who are not directly collaborating with the research team. Design and setting Cross sectional, web based survey. Participants Clinical trialists who were corresponding authors of clinical trials published in 2010 or 2011 in one of six general medical journals with the highest impact factor in 2011. Main outcome measures Support for and prevalence of data sharing through data repositories and in response to individual requests, concerns with data sharing through repositories, and reasons for granting or denying requests. Results Of 683 potential respondents, 317 completed the survey (response rate 46%). In principle, 236 (74%) thought that sharing de-identified data through data repositories should be required, and 229 (72%) thought that investigators should be required to share de-identified data in response to individual requests. In practice, only 56 (18%) indicated that they were required by the trial funder to deposit the trial data in a repository; of these 32 (57%) had done so. In all, 149 respondents (47%) had received an individual request to share their clinical trial data; of these, 115 (77%) had granted and 56 (38%) had denied at least one request. Respondents’ most common concerns about data sharing were related to appropriate data use, investigator or funder interests, and protection of research subjects. Conclusions We found strong support for sharing clinical trial data among corresponding authors of recently published trials in high impact general medical journals who responded to our survey, including a willingness to share data, although several practical concerns were identified.

Gender Differences in the Trajectory of Recovery in Health Status Among Young Patients With Acute Myocardial Infarction Results From the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) Study

Background— Despite the excess risk of mortality in young women (⩽55 years of age) after acute myocardial infarction (AMI), little is known about young women’s health status (symptoms, functioning, quality of life) during the first year of recovery after an AMI. We examined gender differences in health status over time from baseline to 12 months after AMI. Methods and Results— A total of 3501 AMI patients (67% women) 18 to 55 years of age were enrolled from 103 US and 24 Spanish hospitals. Data were obtained by medical record abstraction and patient interviews at baseline hospitalization and 1 and 12 months after AMI. Health status was measured by generic (Short Form-12) and disease-specific (Seattle Angina Questionnaire) measures. We compared health status scores at all 3 time points and used longitudinal linear mixed-effects analyses to examine the independent effect of gender, adjusting for time and selected covariates. Women had significantly lower health status scores than men at each assessment (all P values <0.0001). After adjustment for time and all covariates, women had Short Form-12 physical/mental summary scores that were −0.96 (95% confidence interval [CI], −1.59 to −0.32) and −2.36 points (95% CI, −2.99 to −1.73) lower than those of men, as well as worse Seattle Angina Questionnaire physical limitations (−2.44 points lower; 95% CI, −3.53 to −1.34), more angina (−1.03 points lower; 95% CI, −1.98 to −0.07), and poorer quality of life (−3.51 points lower; 95% CI, −4.80 to −2.22). Conclusion— Although both genders recover similarly after AMI, women have poorer scores than men on all health status measures, a difference that persisted throughout the entire year after discharge.

Effect of Low Perceived Social Support on Health Outcomes in Young Patients With Acute Myocardial Infarction: Results From the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) Study

Background Social support is an important predictor of health outcomes after acute myocardial infarction (AMI), but social support varies by sex and age. Differences in social support could account for sex differences in outcomes of young patients with AMI. Methods and Results Data from the Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study, an observational study of AMI patients aged ≤55 years in the United States and Spain, were used for this study. Patients were categorized as having low versus moderate/high perceived social support using the ENRICHD Social Support Inventory. Outcomes included health status (Short Form‐12 physical and mental component scores), depressive symptoms (Patient Health Questionnaire), and angina‐related quality of life (Seattle Angina Questionnaire) evaluated at baseline and 12 months. Among 3432 patients, 21.2% were classified as having low social support. Men and women had comparable levels of social support at baseline. On average, patients with low social support reported lower functional status and quality of life and more depressive symptoms at baseline and 12 months post‐AMI. After multivariable adjustment, including baseline health status, low social support was associated with lower mental functioning, lower quality of life, and more depressive symptoms at 12 months (all P<0.001). The relationship between low social support and worse physical functioning was nonsignificant after adjustment (P=0.6). No interactions were observed between social support, sex, or country. Conclusion Lower social support is associated with worse health status and more depressive symptoms 12 months after AMI in both young men and women. Sex did not modify the effect of social support.

Hospital Patterns of Use of Positive Inotropic Agents in Patients with Heart Failure

OBJECTIVES This study sought to determine hospital variation in the use of positive inotropic agents in patients with heart failure. BACKGROUND Clinical guidelines recommend targeted use of positive inotropic agents in highly selected patients, but data are limited and the recommendations are not specific. METHODS We analyzed data from 376 hospitals including 189,948 hospitalizations for heart failure from 2009 through 2010. We used hierarchical logistic regression models to estimate hospital-level risk-standardized rates of inotrope use and risk-standardized in-hospital mortality rates. RESULTS The risk-standardized rates of inotrope use ranged across hospitals from 0.9% to 44.6% (median: 6.3%, interquartile range: 4.3% to 9.2%). We identified various hospital patterns based on the type of agents: dobutamine-predominant (29% of hospitals), dopamine-predominant (25%), milrinone-predominant (1%), mixed dobutamine and dopamine pattern (32%), and mixed pattern including all 3 agents (13%). When studying the factors associated with interhospital variation, the best model performance was with the hierarchical generalized linear models that adjusted for patient case mix and an individual hospital effect (receiver operating characteristic curves from 0.77 to 0.88). The intraclass correlation coefficients of the hierarchical generalized linear models (0.113 for any inotrope) indicated that a noteworthy proportion of the observed variation was related to an individual institutional effect. Hospital rates or patterns of use were not associated with differences in length of stay or risk-standardized mortality rates. CONCLUSIONS We found marked differences in the use of inotropic agents for heart failure patients among a diverse group of hospitals. This variability, occurring in the context of little clinical evidence, indicates an urgent need to define the appropriate use of these medications.

Acute Decompensated Heart Failure Is Routinely Treated as a Cardiopulmonary Syndrome

Background Heart failure as recognized and treated in typical practice may represent a complex condition that defies discrete categorizations. To illuminate this complexity, we examined treatment strategies for patients hospitalized and treated for decompensated heart failure. We focused on the receipt of medications appropriate for other acute conditions associated with shortness of breath including acute asthma, pneumonia, and exacerbated chronic obstructive pulmonary disease. Methods and Results Using Premier Perspective®, we studied adults hospitalized with a principal discharge diagnosis of heart failure and evidence of acute heart failure treatment from 2009-2010 at 370 US hospitals. We determined treatment with acute respiratory therapies during the initial 2 days of hospitalization and daily during hospital days 3-5. We also calculated adjusted odds of in-hospital death, admission to the intensive care unit, and late intubation (intubation after hospital day 2). Among 164,494 heart failure hospitalizations, 53% received acute respiratory therapies during the first 2 hospital days: 37% received short-acting inhaled bronchodilators, 33% received antibiotics, and 10% received high-dose corticosteroids. Of these 87,319 hospitalizations, over 60% continued receiving respiratory therapies after hospital day 2. Respiratory treatment was more frequent among the 60,690 hospitalizations with chronic lung disease. Treatment with acute respiratory therapy during the first 2 hospital days was associated with higher adjusted odds of all adverse outcomes. Conclusions Acute respiratory therapy is administered to more than half of patients hospitalized with and treated for decompensated heart failure. Heart failure is therefore regularly treated as a broader cardiopulmonary syndrome rather than as a singular cardiac condition.

Depressive Symptoms in Younger Women and Men With Acute Myocardial Infarction: Insights From the VIRGO Study

Background Depression was recently recognized as a risk factor for adverse medical outcomes in patients with acute myocardial infarction (AMI). The degree to which depression is present among younger patients with an AMI, the patient profile associated with being a young AMI patient with depressive symptoms, and whether relevant sex differences exist are currently unknown. Methods and Results The Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients (VIRGO) study enrolled 3572 patients with AMI (67.1% women; 2:1 ratio for women to men) between 2008 and 2012 (at 103 hospitals in the United States, 24 in Spain, and 3 in Australia). Information about lifetime history of depression and depressive symptoms experienced over the past 2 weeks (Patient Health Questionnaire; a cutoff score ≥10 was used for depression screening) was collected during index AMI admission. Information on demographics, socioeconomic status, cardiovascular risk, AMI severity, perceived stress (14‐item Perceived Stress Scale), and health status (Seattle Angina Questionnaire, EuroQoL 5D) was obtained through interviews and chart abstraction. Nearly half (48%) of the women reported a lifetime history of depression versus 1 in 4 in men (24%; P<0.0001). At the time of admission for AMI, more women than men experienced depressive symptoms (39% versus 22%, P<0.0001; adjusted odds ratio 1.64; 95% CI 1.36 to 1.98). Patients with more depressive symptoms had higher levels of stress and worse quality of life (P<0.001). Depressive symptoms were more prevalent among patients with lower socioeconomic profiles (eg, lower education, uninsured) and with more cardiovascular risk factors (eg, diabetes, smoking). Conclusions A high rate of lifetime history of depression and depressive symptoms at the time of an AMI was observed among younger women compared with men. Depressive symptoms affected those with more vulnerable socioeconomic and clinical profiles.