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Background Depression after acute coronary syndrome (ACS) is common and increases risks of adverse outcomes, but it remains unclear which depression features are most associated with major adverse cardiac events (MACE) and all-cause mortality (ACM). Purpose To examine whether a subtype of depression characterized by anhedonia and major depressive disorder (MDD) predicts 1-year MACE/ACM occurrence in ACS patients compared to no MDD history. We also consider other depression features in the literature as predictors. Methods Patients (N = 1,087) presenting to a hospital with ACS completed a self-report measure of current depressive symptoms in-hospital and a diagnostic interview assessing MDD within 1 week post-hospitalization. MACE/ACM events were assessed at 1-, 6-, and 12-month follow-ups. Cox regression models were used to examine the association of the anhedonic depression subtype and MDD without anhedonia with time to MACE/ACM, adjusting for sociodemographic and clinical covariates. Results There were 142 MACE/ACM events over the 12-month follow-up. The 1-year MACE/ACM in patients with anhedonic depression, compared to those with no MDD, was somewhat higher in an age-adjusted model (hazard ratio [HR] = 1.63, p = .08), but was not significant after further covariate adjustment (HR = 1.24, p = .47). Of the additional depression features, moderate-to-severe self-reported depressive symptoms significantly predicted the risk of MACE/ACM, even in covariate-adjusted models (HR = 1.72, p = .04), but the continuous measure of self-reported depressive symptoms did not. Conclusion The anhedonic depression subtype did not uniquely predict MACE/ACM as hypothesized. Moderate-to-severe levels of total self-reported depressive symptoms, however, may be associated with increased MACE/ACM risk, even after accounting for potential sociodemographic and clinical confounders.

BACKGROUND Being physically active is critical to successful aging, but most older adults don’t move enough. Research has shown that even small increases in activity can have a significant impact on risk reduction and improve quality of life. Behavior Change Techniques (BCTs) associated with increases in activity have been identified, but prior studies on their effectiveness have primarily looked at their use in between-subjects trials and in aggregate. These approaches, while robust, fail to identify those BCTs most influential for a given individual. A personalized, or N-of-1, trial design can address this by assessing a person’s response to each specific intervention. OBJECTIVE This study is designed to test the feasibility, acceptability, and preliminary effectiveness of a virtually delivered personalized behavioral intervention to increase low-intensity physical activity (i.e., walking) in adults 45 to 75 years old. METHODS The study will be administered over 10 weeks with a 2-week baseline period followed by 4 BCTs delivered one at a time, each for 2 weeks. Physical activity will be continuously measured by a wearable activity tracker, and intervention components and outcome measures will be delivered and collected by email, text messages, and surveys. Participant satisfaction with the personalized trial will be measured at the intervention's RESULTS Examining the effect of each BCT in isolation will allow for the unique impact to be assessed. CONCLUSIONS Assessing the feasibility and acceptability of delivering a remote physical activity intervention for older adults is needed if implementation of successful behavior change can be attained. Finally, in using a personalized trial design, heterogeneity of individual responses for each BCT can be quantified and inform later National Institutes of Health (NIH) Stages of Intervention development trials.

Lay abstract Commonly, research studies seek to enroll large groups of individuals to test a new product or medication. However, the personalized trial/N-of-1 trial has a different goal. This is to focus on a single person and study their response to different treatments. Our focus group-based study of medical providers and racial and ethnic minority patients, sought to learn how personalized trials can be designed to include the life experiences and cultural considerations of members of minority populations. Participants noted factors such as the role of family, including educational programming or lifestyle changes in the trial, and the use of natural remedies (not prescribed by a physician) as specific cultural considerations. N-of-1 trials have the potential to change the way we deliver primary care and improve disparities, but we must design them to address the concerns of importance to minority populations.

OBJECTIVE Personalized trials have the potential to improve the precision of treatment selection and foster patient involvement in clinical decision making. Little is known about the attitudes of patients with multimorbidities. To address this, stakeholders designed and conducted a national survey that determined general attitudes and features of personalized trials that may increase their use among patients with multimorbidities in clinical and research practice. METHOD A multistakeholder collaboratory of patients, clinicians, scientists, methodologists, statisticians, and research disseminators designed a survey to determine the conditions, symptoms, and design attributes most applicable to personalized trials according to patients. A sample of U.S. patients with two or more prespecified personalized-trial-amenable chronic conditions completed the online survey. RESULTS Multimorbid participants (N = 501; M age = 56.1 years) showed that some conditions, symptoms or use cases for personalized trials include pain (57.6%), hypertension (38.8%), diabetes (28.8%), sleep problems (27.4%), and depression (23.0%). Overall, 82.0% of the participants with multimorbidities were interested in participating in personalized trials. The percentage that were interested varied by trial attributes, including physician involvement (86.4%), patient-driven treatment selection (88.0%), clinician blinding (59.2%), placebo treatment options (57.5%), and out-of-pocket costs (41.8%). CONCLUSION Participants with multimorbidities identified prevalent use cases that are suited to personalized trials. Participants also identified design features of such trials, including patient-driven treatment selection, active comparators, and nonblinding. This study demonstrates that eliciting input from a collaboratory and patients with multimorbidities can inform research priorities for this rapidly growing patient population and increase adoption by researchers and clinicians alike. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Addressing gender and racial-ethnic disparities at all career stages is a priority for the research community. In this article, we focus on efforts to encourage mid-career women, particularly women of color, to move into leadership positions in science and science policy. We highlight the need to strengthen leadership skills for the critical period immediately following promotion to associate/tenured professor – when formal career development efforts taper off while institutional demands escalate – and describe a program called MAVEN that has been designed to teach leadership skills to mid-career women scientists, particularly those from underrepresented groups.

Background Elevated depressive symptoms among survivors of acute coronary syndromes (ACS) confer recurrent cardiovascular events and mortality, worse quality of life, and higher healthcare costs. While multiple scientific groups advise routine depression screening for ACS survivors, no randomized trials exist to inform this screening recommendation. We aimed to assess the effect of screening for depression on change in quality of life over 18 months among ACS patients. Methods The Comparison of Depression Identification after Acute Coronary Syndrome on Quality of Life and Cost Outcomes (CODIACS-QoL) trial is a pragmatic, 3-arm trial that randomized ACS patients to 1) systematic depression screening using the 8-item Patient Health Questionnaire (PHQ-8) and if positive screen (PHQ-8 ≥ 10), notification of primary care providers (PCPs) and invitation to participate in centralized, patient-preference, stepped depression care (Screen, Notify, and Treat, N = 499); 2) systematic depression screening and PCP notification only (Screen and Notify, N = 501); and 3) usual care (No Screen, N = 500). Adults hospitalized for ACS in the previous 2–12 months without prior history of depression were eligible for participation. Key outcomes will be quality-adjusted life years (primary), cost of health care utilization, and depression-free days across 18 months. Results A total of 1500 patients were randomized in the CODIACS-QOL trial (28.3% women; 16.3% Hispanic; mean age 65.9 (11.5) years). Only 7% of ACS survivors had elevated depressive symptoms. Conclusions Using a novel randomization schema and pragmatic design principles, the CODIACS-QoL trial achieved its enrollment target. Eventual results of this trial will inform future depression screening recommendations in cardiac patients. Trial registration: ClinicalTrials.gov (NCT 01993017).

ObjectiveTo describe individual patient preferences for Personalised Trials and to identify factors and conditions associated with patient preferences.DesignEach participant was presented with 18 conjoint questions via an online survey. Each question provided two choices of Personalised Trials that were defined by up to eight attributes, including treatment types, clinician involvement, study logistics and trial burden on a patient.SettingOnline survey of adults with at least two common chronic conditions in the USA.ParticipantsA nationally representative sample of 501 individuals were recruited from the Chronic Illness Panel by Harris Poll Online. Participants were recruited from several sources, including emails, social media and telephone recruitment of the target population.Main outcome measuresThe choice of Personalised Trial design that the participant preferred with each conjoint question.ResultsThere was large variability in participants’ preferences for the design of Personalised Trials. On average, they preferred certain attributes, such as a short time commitment and no cost. Notably, a population-level analysis correctly predicted 62% of the conjoint responses. An empirical Bayesian analysis of the conjoint data, which supported the estimation of individual-level preferences, improved the accuracy to 86%. Based on estimates of individual-level preferences, patients with chronic pain preferred a long study duration (p≤0.001). Asthma patients were less averse to participation burden in terms of data-collection frequency than patients with other conditions (p=0.002). Patients with hypertension were more cost-sensitive (pConclusionThese analyses provide a framework for elucidating individual-level preferences when implementing novel patient-centred interventions. The data showed that patient preference in Personalised Trials is highly variable, suggesting that individual differences must be accounted for when marketing Personalised Trials. These results have implications for advancing precise interventions in Personalised Trials by indicating when rigorous scientific principles, such as frequent monitoring, is feasible in a substantial subset of patients.

Importance There is limited information describing the presenting characteristics and outcomes of US patients requiring hospitalization for coronavirus disease 2019 (COVID-19). Objective To describe the clinical characteristics and outcomes of patients with COVID-19 hospitalized in a US health care system. Design, Setting, and Participants Case series of patients with COVID-19 admitted to 12 hospitals in New York City, Long Island, and Westchester County, New York, within the Northwell Health system. The study included all sequentially hospitalized patients between March 1, 2020, and April 4, 2020, inclusive of these dates. Exposures Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by positive result on polymerase chain reaction testing of a nasopharyngeal sample among patients requiring admission. Main Outcomes and Measures Clinical outcomes during hospitalization, such as invasive mechanical ventilation, kidney replacement therapy, and death. Demographics, baseline comorbidities, presenting vital signs, and test results were also collected. Results A total of 5700 patients were included (median age, 63 years [interquartile range {IQR}, 52-75; range, 0-107 years]; 39.7% female). The most common comorbidities were hypertension (3026; 56.6%), obesity (1737; 41.7%), and diabetes (1808; 33.8%). At triage, 30.7% of patients were febrile, 17.3% had a respiratory rate greater than 24 breaths/min, and 27.8% received supplemental oxygen. The rate of respiratory virus co-infection was 2.1%. Outcomes were assessed for 2634 patients who were discharged or had died at the study end point. During hospitalization, 373 patients (14.2%) (median age, 68 years [IQR, 56-78]; 33.5% female) were treated in the intensive care unit care, 320 (12.2%) received invasive mechanical ventilation, 81 (3.2%) were treated with kidney replacement therapy, and 553 (21%) died. As of April 4, 2020, for patients requiring mechanical ventilation (n = 1151, 20.2%), 38 (3.3%) were discharged alive, 282 (24.5%) died, and 831 (72.2%) remained in hospital. The median postdischarge follow-up time was 4.4 days (IQR, 2.2-9.3). A total of 45 patients (2.2%) were readmitted during the study period. The median time to readmission was 3 days (IQR, 1.0-4.5) for readmitted patients. Among the 3066 patients who remained hospitalized at the final study follow-up date (median age, 65 years [IQR, 54-75]), the median follow-up at time of censoring was 4.5 days (IQR, 2.4-8.1). Conclusions and Relevance This case series provides characteristics and early outcomes of sequentially hospitalized patients with confirmed COVID-19 in the New York City area.

Importance Patients with acute coronary syndrome (ACS) and elevated depressive symptoms are at increased risk for recurrent cardiovascular events and mortality, worse quality of life, and higher health care costs. These observational findings prompted multiple scientific panels to advise universal depression screening in survivors of ACS prior to evidence from randomized screening trials. Objective To determine whether systematically screening for depression in survivors of ACS improves quality of life and depression compared with usual care. Design, Setting, and Participants A 3-group multisite randomized trial enrolled 1500 patients with ACS from 4 health care systems between November 1, 2013, and March 31, 2017, with follow-up ending July 31, 2018. Patients were eligible if they had been hospitalized for ACS in the previous 2 to 12 months and had no prior history of depression. All analyses were performed on an intention-to-treat basis. Interventions Patients with ACS were randomly assigned 1:1:1 to receive (1) systematic depression screening using the 8-item Patient Health Questionnaire, with notification of primary care clinicians and provision of centralized, patient-preference, stepped depression care for those with positive screening results (8-item Patient Health Questionnaire score ≥10; screen, notify, and treat, n = 499); (2) systematic depression screening, with notification of primary care clinicians for those with positive screening results (screen and notify, n = 501); and (3) usual care (no screening, n = 500). Main Outcomes and Measures The primary outcome was change in quality-adjusted life-years. The secondary outcome was depression-free days. Adverse effects and mortality were assessed by patient interview and hospital records. Results A total of 1500 patients (424 women and 1076 men; mean [SD] age, 65.9 [11.5] years) were randomized in the 18-month trial. Only 71 of 1000 eligible survivors of ACS (7.1%) had elevated 8-item Patient Health Questionnaire scores indicating depressive symptoms at screening. There were no differences in mean (SD) change in quality-adjusted life-years (screen, notify and treat, –0.06 [0.20]; screen and notify, −0.06 [0.20]; no screen, −0.06 [0.18];P = .98) or cumulative mean (SD) depression-free days (screen, notify and treat, 343.1 [179.0] days; screen and notify, 351.3 [175.0] days; no screen, 339.0 [176.6] days;P = .63). Harms including death, bleeding, or sleep difficulties did not differ among groups. Conclusions and Relevance In patients with ACS without a history of depression, systematic depression screening with or without providing depression treatment did not alter quality-adjusted life-years, depression-free days, or harms. Trial Registration ClinicalTrials.gov identifier:NCT01993017

OBJECTIVE: Despite their promise for increasing treatment precision, Personalized Trials (i.e., N-of-1 trials) have not been widely adopted. We aimed to ascertain patient preferences for Personalized Trials. STUDY DESIGN AND SETTING: We recruited 501 adults with ≥2 common chronic conditions from Harris Poll Online. We used Sawtooth Software to generate 45 plausible Personalized Trial designs comprised of combinations of 8 key attributes (treatment selection, treatment type, clinician involvement, blinding, time commitment, self-monitoring frequency, duration, cost) at different levels. Conditional logistic regression was used to assess relative importance of different attributes using a random utility maximization model. RESULTS: Overall, participants preferred Personalized Trials with no costs vs. $100 cost (utility difference 1.52 [standard error 0.07], p

Psychosocial stress contributes to heart disease in part by adversely affecting maintenance of health behaviors, while exercise can reduce stress. Assessing the bi-directional relationship between stress and exercise has been limited by lack of real-time data and theoretical and statistical models. This lack may hinder efforts to promote exercise maintenance. We test the bi-directional relationship between stress and exercise using real-time data for the average person and the variability—individual differences—in this relationship. An observational study was conducted within a single cohort randomized controlled experiment. Healthy young adults, (n = 79) who reported only intermittent exercise, completed 12 months of stress monitoring by ecological momentary assessment (at the beginning of, end of, and during the day) and continuous activity monitoring by Fitbit. A random coefficients linear mixed model was used to predict end-of-day stress from the occurrence/non-occurrence of exercise that day; a logistic mixed model was used to predict the occurrence/non-occurrence of exercise from ratings of anticipated stress. Separate regression analyses were also performed for each participant. Sensitivity analysis tested all models, restricted to the first 180 days of observation (prior to randomization). We found a significant average inverse (i.e., negative) effect of exercise on stress and of stress on exercise. There was significant between-person variability. Of N = 69, exercise was associated with a stress reduction for 15, a stress increase for 2, and no change for the remainder. We also found that an increase in anticipated stress reported the previous night or that morning was associated with a significant 20–22% decrease (OR = 0.78–0.80) in the odds of exercising that day. Of N = 69, this increase in stress reduced the likelihood of exercise for 17, increased the odds for 1, and had no effect for the remainder. We were unable to identify psychosocial factors that moderate the individual differences in these effects. The relationship of stress to exercise can be uni- or bi-directional and varies from person to person. A precision medicine approach may improve exercise uptake.

Aims: As many as 1 in 8 acute coronary syndrome (ACS) patients develop posttraumatic stress disorder (PTSD) due to the ACS, and ACS-induced PTSD may increase secondary cardiovascular disease (CVD) risk. However, prior studies have been small and underpowered to test plausible behavioral or biological mechanisms of the hypothesized PTSD-secondary CVD risk association. In this paper, we describe the design and methods of a large prospective observational cohort study to estimate the prognostic significance of ACS-induced PTSD, mechanisms for its association with CVD risk, and emergency department (ED) factors that may increase PTSD risk, in a cohort of patients evaluated for acute coronary syndrome (ACS) in the ED of a large, urban academic medical center. Methods: The Reactions to Acute Care and Hospitalization (ReACH) study follows 1,741 racially, ethnically, and socioeconomically diverse patients initially presenting to the ED with ACS symptoms. Psychosocial factors are assessed at baseline. Medication adherence is monitored by electronic pill bottle (eCAP). Participants are contacted by phone at 1-, 6-, and 12-months post-hospitalization to assess PTSD symptoms, hospital readmission, and recurrent CVD events/mortality (proactively searched and confirmed by medical records). Conclusion: This study will provide the most accurate estimates to date of PTSD’s association with recurrent CVD events and mortality and will test whether medication adherence mediates that association. Further, it will provide estimates of the contribution of ED and hospital factors to PTSD risk in ACS patients. If our hypotheses are supported, we will have identified PTSD as a novel target for secondary risk reduction.

This paper describes the rationale and design of the vanguard for the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS), a multicenter, randomized, controlled trial of a patient preference‐based, stepped care protocol for persistent depressive symptoms after acute coronary syndrome (ACS). The overall aim of the vanguard phase was to determine whether the patient-preference, stepped care protocol, which is based on the intervention used in the recent Coronary Psychosocial Evaluation Studies (COPES) trial, was feasible in patients with recent ACS who were recruited from 5 geographically diverse sites. Innovative design features of this trial include randomization to either initial patient-preference of treatment or to a referred care arm in which the primary care provider decided upon care. Additionally, delivery of psychotherapy was accomplished by telephone, or webcam, depending upon patient preference. The vanguard phase provides estimates of eligibility and screening/enrollment ratios, patient acceptance of screening, and retention. In this report, we describe the innovative features and the baseline results of the vanguard phase of CODIACS. The data from this vanguard study will be used to finalize planning for a large, phase III clinical trial designed to evaluate the effect of treatment on depressive symptoms, coronary events, and death.

Importance Controversy remains about whether depression can be successfully managed after acute coronary syndrome (ACS) and the costs and benefits of doing so. Objective To determine the effects of providing post-ACS depression care on depressive symptoms and health care costs. Design Multicenter randomized controlled trial. Setting Patients were recruited from 2 private and 5 academic ambulatory centers across the United States. Participants A total of 150 patients with elevated depressive symptoms (Beck Depression Inventory [BDI] score ≥10) 2 to 6 months after an ACS, recruited between March 18, 2010, and January 9, 2012. Interventions Patients were randomized to 6 months of centralized depression care (patient preference for problem-solving treatment given via telephone or the Internet, pharmacotherapy, both, or neither), stepped every 6 to 8 weeks (active treatment group; n = 73), or to locally determined depression care after physician notification about the patient's depressive symptoms (usual care group; n = 77). Main Outcome Measures Change in depressive symptoms during 6 months and total health care costs. Results Depressive symptoms decreased significantly more in the active treatment group than in the usual care group (differential change between groups, −3.5 BDI points; 95% CI, −6.1 to −0.7; P = .01). Although mental health care estimated costs were higher for active treatment than for usual care, overall health care estimated costs were not significantly different (difference adjusting for confounding, −$325; 95% CI, −$2639 to $1989; P = .78). Conclusions For patients with post-ACS depression, active treatment had a substantial beneficial effect on depressive symptoms. This kind of depression care is feasible, effective, and may be cost-neutral within 6 months; therefore, it should be tested in a large phase 3 pragmatic trial. Trial Registration clinicaltrials.gov Identifier: NCT01032018