The association of cognitive and somatic depressive symptoms with depression recognition and outcomes after myocardial infarction

BACKGROUND: Among patients with acute myocardial infarction (AMI), depression is both common and under-recognized. The association of different manifestations of depression, somatic and cognitive, with depression recognition and long-term prognosis is poorly understood. METHODS AND RESULTS: Depression was confirmed in 481 AMI patients enrolled from 21 sites during their index hospitalization with a Patient Health Questionnaire (PHQ-9) score ≥10. Within the PHQ-9, separate somatic and cognitive symptom scores were derived and the independent association between these domains and the clinical recognition of depression, as documented in the medical records, was evaluated. In a separate multisite AMI registry of 2,347 patients, the association between somatic and cognitive depressive symptoms and 4-year all-cause mortality and 1-year all-cause rehospitalization was evaluated. Depression was clinically recognized in 29% (n=140) of patients. Cognitive depressive symptoms (Relative Risk [RR] per Standard Deviation [SD] increase=1.14; 95% confidence interval [CI] 1.03–1.26; p=0.01) were independently associated with depression recognition, while the association for somatic symptoms and recognition (RR=1.04; 95% CI 0.87–1.26; p=0.66) was not significant. However, unadjusted Cox regression analyses found that only somatic depressive symptoms were associated with 4-year mortality (Hazard Ratio [HR] per SD increase=1.22; 95% confidence interval [CI] 1.08–1.39) or 1-year rehospitalization (HR=1.22; 95%CI 1.11–1.33) while cognitive manifestations were not (HR for mortality=1.01; 95%CI 0.89–1.14; HR for rehospitalization=1.01; 95%CI 0.93–1.11). After multivariable adjustment, the association between somatic symptoms and rehospitalization persisted (HR=1.16; 95% CI:1.06–1.27; p=0.01) but was attenuated for mortality (HR=1.07; 95% CI:0.94–1.21; p=0.30). CONCLUSIONS: Depression after AMI was recognized in fewer than 1 in 3 patients. Although cognitive symptoms were associated with recognition of depression, somatic symptoms were associated with long-term outcomes. Comprehensive screening and treatment of both somatic and cognitive symptoms may be necessary to optimize depression recognition and treatment in AMI patients

Financial stress and outcomes after acute myocardial infarction

Little is known about the association between financial stress and health care outcomes. Our objective was to examine the association between self-reported financial stress during initial hospitalization and long-term outcomes after acute myocardial infarction (AMI).We used prospective registry evaluating myocardial infarction: Event and Recovery (PREMIER) data, an observational, multicenter US study of AMI patients discharged between January 2003 and June 2004. Primary outcomes were disease-specific and generic health status outcomes at 1 year (symptoms, function, and quality of life (QoL)), assessed by the Seattle Angina Questionnaire [SAQ] and Short Form [SF]-12. Secondary outcomes included 1-year rehospitalization and 4-year mortality. Hierarchical regression models accounted for patient socio-demographic, clinical, and quality of care characteristics, and access and barriers to care.Among 2344 AMI patients, 1241 (52.9%) reported no financial stress, 735 (31.4%) reported low financial stress, and 368 (15.7%) reported high financial stress. When comparing individuals reporting low financial stress to no financial stress, there were no significant differences in post-AMI outcomes. In contrast, individuals reporting high financial stress were more likely to have worse physical health (SF-12 PCS mean difference -3.24, 95% Confidence Interval [CI]: -4.82, -1.66), mental health (SF-12 MCS mean difference: -2.44, 95% CI: -3.83, -1.05), disease-specific QoL (SAQ QoL mean difference: -6.99, 95% CI: -9.59, -4.40), and be experiencing angina (SAQ Angina Relative Risk = 1.66, 95%CI: 1.19, 2.32) at 1 year post-AMI. While 1-year readmission rates were increased (Hazard Ratio = 1.50; 95%CI: 1.20, 1.86), 4-year mortality was no different.High financial stress is common and an important risk factor for worse long-term outcomes post-AMI, independent of access and barriers to care.Sachin J. Shah, Harlan M. Krumholz, Kimberly J. Reid, Saif S. Rathore, Aditya Mandawat, John A. Spertus, Joseph S. Ros

"I'm not just a heart, I'm a whole person here": a qualitative study to improve sexual outcomes in women with myocardial infarction

Background: Little is known about recovery of female sexual function following an acute myocardial infarction (MI). Interventions to improve sexual outcomes in women are limited. Methods and Results: Semistructured, qualitative telephone interviews were conducted with 17 partnered women (aged 43 to 75 years) purposively selected from the Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients’ Health Status Registry to deepen knowledge of recovery of female sexual function following an acute myocardial infarction (MI) and to improve sexual outcomes in women. Sixteen women had a monogamous relationship with a male spouse; 1 had a long‐term female partner. Most women resumed sexual activity within 4 weeks of their MI. Sexual problems and concerns were prevalent, including patient and/or partner fear of “causing another heart attack.” Few women received counseling about sexual concerns or the safety of returning to sex. Most women who discussed sex with a physician initiated the discussion themselves. Inquiry about strategies to improve sexual outcomes elicited key themes: need for privacy, patient‐centeredness, and information about the timing and safe resumption of sexual activity. In addition, respondents felt that counseling should be initiated by the treating cardiologist, who “knows whether your heart is safe,” and then reinforced by the care team throughout the rehabilitation period. Conclusions: Partnered women commonly resume sexual activity soon after an MI with fear but without directed counseling from their physicians. Proactive attention to women's concerns related to sexual function and the safety of sexual activity following an MI could improve post‐MI outcomes for women and their partners.Emily M. Abramsohn, Carole Decker, Brian Garavalia, Linda Garavalia, Kensey Gosch, Harlan M. Krumholz, John A. Spertus and Stacy Tessler Linda

Factors associated with return to work after acute myocardial infarction in China

Importance: Return to work is an important indicator of recovery after acute myocardial infarction. Little is known, however, about the rate of returning to work within the year after an acute myocardial infarction in China, as well as the factors associated with returning to work after an acute myocardial infarction. Objectives: To determine the rate of return to work within 12 months after acute myocardial infarction, classify the reasons why patients did not return to work, and identify patient factors associated with returning to work. Design, Setting, and Participants: This prospective cohort study, conducted in 53 hospitals across 21 provinces in China, identified 1566 patients who were employed at the time of the index acute myocardial infarction hospitalization and participating in the China Patient-centered Evaluative Assessment of Cardiac Events Prospective Study of Acute Myocardial Infarction. Data collected included patients' baseline characteristics; employment status at 12 months after acute myocardial infarction; and, for those who were not employed at 12 months, potential reasons for not returning to work. A logistic regression model was fitted to identify factors associated with returning to work at 12 months. Data were collected from January 1, 2013, through July 17, 2014, and statistical analysis was conducted from August 9, 2016, to August 15, 2018. Main Outcomes and Measures: Return to work, defined as rejoining the workforce within 12 months after discharge from hospitalization for the index acute myocardial infarction. Results: Of 1566 patients (130 women and 1436 men; mean [SD] age, 52.2 [9.7] years), 875 patients (55.9%; 95% CI, 53.4%-58.3%) returned to work by 12 months after acute myocardial infarction. Among the 691 patients who did not return to work, 287 (41.5%) were unable to work and/or preferred not to work because of acute myocardial infarction and 131 (19.0%) retired early owing to the acute myocardial infarction. Female sex (relative risk, 0.65; 95% CI, 0.41-0.88), a history of smoking (relative risk, 0.82; 95% CI, 0.65-0.98), and in-hospital complications during the index acute myocardial infarction (relative risk, 0.96; 95% CI, 0.93-0.99) were associated with a lower likelihood of returning to work. Conclusions and Relevance: Almost half of the previously employed Chinese patients did not return to work within 12 months after acute myocardial infarction. Female sex, history of smoking, and in-hospital complications were associated with a lower likelihood of returning to work.Zihan Jiang, Rachel P. Dreyer, John A. Spertus, Frederick A. Masoudi, Jing Li, Xin Zheng, Xi Li, Chaoqun Wu, Xueke Bai, Shuang Hu, Yun Wang, Harlan M. Krumholz, Hong Chen [for the China Patient-centered Evaluative Assessment of Cardiac Events (PEACE) Collaborative Group

Qingdao port cardiovascular health study: a prospective cohort study

PURPOSE:In China, efforts are underway to respond to rapidly increasing rates of heart disease and stroke. Yet the epidemiology of cardiovascular disease in China may be different from that of other populations. Thus, there is a critical need for population-based studies that provide insight into the risk factors, incidence and outcomes of cardiovascular disease in China. The Qingdao Port Cardiovascular Health Study is designed to investigate the burden of cardiovascular disease and the sociodemographic, biological, environmental and clinical risk factors associated with disease onset and outcomes. PARTICIPANTS:For this study, from 2000 through 2013, 32,404 employees aged 18 years or older were recruited from the Qingdao Port Group in China, contributing 221,923 annual health assessments. The mean age at recruitment was 43.4 (SD=12.9); 79% were male. In this ongoing study, annual health assessments, governed by extensive quality control mechanisms, include a questionnaire (capturing demographic and employment information, medical history, medication use, health behaviours and health outcomes), physical examination, ECG, and blood and urine analysis. Additional non-annual assessments include an X-ray, echocardiogram and carotid ultrasound; bio-samples will be collected for future genetic and proteomic analyses. Cardiovascular outcomes are accessed via self-report and are actively being verified with medical insurance claims; efforts are underway to adjudicate outcomes with hospital medical records. FINDINGS TO DATE:Early findings reveal a significant increase in cardiovascular risk factors from 2000 to 2010 (hypertension: 26.4-39.4%; diabetes: 3.3-8.9%; hyperlipidaemia: 5.0-33.6%; body mass index >28 m/kg(2): 14.1-18.6%). FUTURE PLANS:We aim to generate novel insights about the epidemiology and outcomes of cardiovascular disease in China, with specific emphasis on the potentially unique risk factor profiles of this Chinese population. Knowledge generated will be disseminated in the peer-reviewed literature, and will inform population-based strategies to improve cardiovascular health in China. TRIAL REGISTRATION NUMBER:NCT02329886.Erica S Spatz, Xianyan Jiang, Jiapeng Lu, Frederick A Masoudi, John A Spertus, Yongfei Wang ... et al

Design and rationale of the Cardiovascular Health and Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study: two randomised controlled trials of text messaging to improve secondary prevention for coronary heart disease and diabetes

INTRODUCTION:Mobile health interventions have the potential to promote risk factor management and lifestyle modification, and are a particularly attractive approach for scaling across healthcare systems with limited resources. We are conducting two randomised trials to evaluate the efficacy of text message-based health messages in improving secondary coronary heart disease (CHD) prevention among patients with or without diabetes. METHODS AND ANALYSIS:The Cardiovascular Health And Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study are multicentre, single-blind, randomised controlled trials of text messaging versus standard treatment with 6 months of follow-up conducted in 37 hospitals throughout 17 provinces in China. The intervention group receives six text messages per week which target blood pressure control, medication adherence, physical activity, smoking cessation (when appropriate), glucose monitoring and lifestyle recommendations including diet (in CHAT-DM). The text messages were developed based on behavioural change techniques, using models such as the information-motivation-behavioural skills model, goal setting and provision of social support. A total sample size of 800 patients would be adequate for CHAT Study and sample size of 500 patients would be adequate for the CHAT-DM Study. In CHAT, the primary outcome is the change in systolic blood pressure (SBP) at 6 months. Secondary outcomes include a change in proportion of patients achieving a SBP <140 mm Hg, low-density lipoprotein cholesterol (LDL-C), physical activity, medication adherence, body mass index (BMI) and smoking cessation. In CHAT-DM, the primary outcome is the change in glycaemic haemoglobin (HbA1C) at 6 months. Secondary outcomes include a change in the proportion of patients achieving HbA1C<7%, fasting blood glucose, SBP, LDL-C, BMI, physical activity and medication adherence. ETHICS AND DISSEMINATION:The central ethics committee at the China National Center for Cardiovascular Disease and the Yale University Institutional Review Board approved the CHAT and CHAT-DM studies. Results will be disseminated via usual scientific forums including peer-reviewed publications. TRIAL REGISTRATION NUMBER:CHAT (NCT02888769) and CHAT-DM (NCT02883842); Pre-results.Xiqian Huo, Erica S Spatz, Qinglan Ding, Paul Horak, Xin Zheng, Claire Masters ... et al

Developing validated tools to identify pulmonary embolism in electronic databases: rationale and design of the PE-EHR plus study

Background Contemporary pulmonary embolism (PE) research, in many cases, relies on data from electronic health records (EHRs) and administrative databases that use International Classification of Diseases (ICD) codes. Natural language processing (NLP) tools can be used for automated chart review and patient identification. However, there remains uncertainty with the validity of ICD-10 codes or NLP algorithms for patient identification.Methods The PE-EHR+ study has been designed to validate ICD-10 codes as Principal Discharge Diagnosis, or Secondary Discharge Diagnoses, as well as NLP tools set out in prior studies to identify patients with PE within EHRs. Manual chart review by two independent abstractors by predefined criteria will be the reference standard. Sensitivity, specificity, and positive and negative predictive values will be determined. We will assess the discriminatory function of code subgroups for intermediate- and high-risk PE. In addition, accuracy of NLP algorithms to identify PE from radiology reports will be assessed.Results A total of 1,734 patients from the Mass General Brigham health system have been identified. These include 578 with ICD-10 Principal Discharge Diagnosis codes for PE, 578 with codes in the secondary position, and 578 without PE codes during the index hospitalization. Patients within each group were selected randomly from the entire pool of patients at the Mass General Brigham health system. A smaller subset of patients will also be identified from the Yale-New Haven Health System. Data validation and analyses will be forthcoming.Conclusions The PE-EHR+ study will help validate efficient tools for identification of patients with PE in EHRs, improving the reliability of efficient observational studies or randomized trials of patients with PE using electronic databases.Thrombosis and Hemostasi

Recent Randomized Trials of Antithrombotic Therapy for Patients With COVID-19: JACC State-of-the-Art Review

Endothelial injury and microvascular/macrovascular thrombosis are common pathophysiological features of coronavirus disease-2019 (COVID-19). However, the optimal thromboprophylactic regimens remain unknown across the spectrum of illness severity of COVID-19. A variety of antithrombotic agents, doses, and durations of therapy are being assessed in ongoing randomized controlled trials (RCTs) that focus on outpatients, hospitalized patients in medical wards, and patients critically ill with COVID-19. This paper provides a perspective of the ongoing or completed RCTs related to antithrombotic strategies used in COVID-19, the opportunities and challenges for the clinical trial enterprise, and areas of existing knowledge, as well as data gaps that may motivate the design of future RCTs. © 2021 American College of Cardiology Foundatio

Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo in critically-ill patients with COVID-19: Rationale and design of the INSPIRATION/INSPIRATION-S studies

Background: Microvascular and macrovascular thrombotic events are among the hallmarks of coronavirus disease 2019 (COVID-19). Furthermore, the exuberant immune response is considered an important driver of pulmonary and extrapulmonary manifestations of COVID-19. The optimal management strategy to prevent thrombosis in critically-ill patients with COVID-19 remains unknown. Methods: The Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) and INSPIRATION-statin (INSPIRATION-S) studies test two independent hypotheses within a randomized controlled trial with 2 � 2 factorial design. Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation. The 600 patients undergoing this randomization will be screened and if meeting the eligibility criteria, will undergo an additional double-blind stratified randomization to atorvastatin 20 mg daily versus matching placebo. The primary endpoint, for both hypotheses will be tested for superiority and includes a composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death within 30 days from enrollment. Key secondary endpoints include all-cause mortality, adjudicated VTE, and ventilator-free days. Key safety endpoints include major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count 3 times upper normal limit and clinically-diagnosed myopathy. The primary analyses will be performed in the modified intention-to-treat population. Results will be tested in exploratory analyses across key subgroups and in the intention-to-treat and per-protocol cohorts. Conclusions: INSPIRATION and INSPIRATON-S studies will help address clinically-relevant questions for antithrombotic therapy and thromboinflammatory therapy in critically-ill patients with COVID-19. © 2020 Elsevier Lt