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Abstract Exercise is a cornerstone of preventive medicine and a promising strategy to intervene on the biology of aging. Variation in the response to exercise is a widely accepted concept that dates back to the 1980s with classic genetic studies identifying sequence variations as modifiers of the VO2max response to training. Since that time, the literature of exercise response variance has been populated with retrospective analyses of existing datasets that are limited by a lack of statistical power from technical error of the measurements and small sample sizes, as well as diffuse outcomes, very few of which have included older adults. Prospective studies that are appropriately designed to interrogate exercise response variation in key outcomes identified a priori and inclusive of individuals over the age of 70 are long overdue. Understanding the underlying intrinsic (e.g., genetics and epigenetics) and extrinsic (e.g., medication use, diet, chronic disease) factors that determine robust versus poor responses to various exercise factors will be used to improve exercise prescription to target the pillars of aging and optimize the clinical efficacy of exercise training in older adults. This review summarizes the proceedings of the NIA-sponsored workshop entitled, “Understanding Heterogeneity of Responses to, and Optimizing Clinical Efficacy of, Exercise Training in Older Adults” and highlights the importance and current state of exercise response variation research, particularly in older adults, prevailing challenges, and future directions.

Purpose of Review To summarize evidence of impact of social determinants of health (SDOH) on diabetes risk, morbidity, and mortality and to illustrate this impact in a population context. Recent Findings Key findings from the American Diabetes Association’s scientific review of five SDOH domains (socioeconomic status, neighborhood and physical environment, food environment, health care, social context) are highlighted. Population-based data on Black/African American adults illustrate persisting diabetes disparities and inequities in the SDOH conditions in which this population is born, grows, lives, and ages, with historical contributors. SDOH recommendations from US national committees largely address a health sector response, including health professional education, SDOH measurement, and patient referral to services for social needs. Fewer recommendations address solutions for systemic racism and socioeconomic discrimination as root causes. Summary SDOH are systemic, population-based, cyclical, and intergenerational, requiring extension beyond health care solutions to multi-sector and multi-policy approaches to achieve future population health improvement.

BACKGROUND Poor sleep, defined as short-duration or poor-quality sleep, is a frequently reported condition with many deleterious effects including poorer cognitive functioning, increased accidents, and poorer health. Melatonin has been shown to be an efficacious treatment to manage symptoms of poor sleep. However, the treatment effects of melatonin on sleep can vary greatly between participants. Personalized, or N-of-1, trial designs represent a method for identifying the best treatment for individual participants. Though using N-of-1 trials of melatonin to treat poor sleep is possible, the feasibility, acceptability, and effectiveness of N-of-1 trials using melatonin is unknown. Using the National Institute of Health (NIH) Stage Model for Behavioral Intervention Development, a Stage IB (intervention refinement, modification, and adaptation and pilot testing) design appeared to be needed to address these feasibility questions. OBJECTIVE The current trial series evaluates the feasibility, acceptability, and effectiveness of a series of personalized interventions for virtual delivery of 3 mg– and 0.5 mg–dose melatonin-versus-placebo supplements for self-reported poor sleep among 60 participants. The goal of this study is to provide valuable information about implementing virtual N-of-1 randomized controlled trials to improve poor sleep. METHODS Participants will complete a 2-week baseline followed by six 2-week alternating intervention periods of 3 mg melatonin, 0.5 mg melatonin, and placebo. Participants will be randomly assigned to 2 intervention orders. Feasibility and acceptability of the personalized trial approach will be determined with participants’ ratings of usability and satisfaction with the virtual, personalized intervention delivery system. Effectiveness of the intervention will be measured using participant self-reported sleep quality/duration and Fitbit tracker–measured sleep duration/efficiency. Additional measures will include ecological momentary assessment (EMA) measures of fatigue, stress, pain, mood, concentration, and confidence as well as measures of participant adherence to the intervention, use of the Fitbit tracker, and survey data collection. RESULTS As of the submission of this protocol, recruitment for this NIH Stage IB personalized trial series is approximately 78.3% complete (n = 47). We expect recruitment and data collection to be finalized by June of 2023. CONCLUSIONS Evaluating feasibility, acceptability, and effectiveness of a series of personalized interventions of melatonin will address the longer-term aim of this program of research—is integrating N-of-1 trials useful patient care? The personalized trial series results will be published in a peer-reviewed journal and will follow the CONSORT extension for N-of-1 trials (CENT 2015) reporting guidelines. This trial series was approved by the Northwell Health Institutional Review Board (IRB). CLINICALTRIAL ClinicalTrials.gov (number NCT05349188).

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.

Current prevalence of obstructive sleep apnea (OSA) in the US is not well established; however, based on cohort and survey data, in 2007-2010 the estimated prevalence of at least mild OSA (defined as an apnea-hypoxia index [AHI] ≥5) plus symptoms of daytime sleepiness among adults aged 30 to 70 years was 14% for men and 5% for women, and the estimated prevalence of moderate to severe OSA (defined as AHI ≥15) was 13% for men and 6% for women. Severe OSA is associated with increased all-cause mortality. Other adverse health outcomes associated with untreated OSA include cardiovascular disease and cerebrovascular events, type 2 diabetes, cognitive impairment, decreased quality of life, and motor vehicle crashes.To update its 2017 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review to evaluate the benefits and harms of screening for OSA in adults.Asymptomatic adults (18 years or older) and adults with unrecognized symptoms of OSA.The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for OSA in the general adult population.The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for OSA in the general adult population. (I statement).

Background: End-stage renal disease is associated with a high risk of cardiovascular events. It is unknown, however, whether mild-to-moderate kidney dysfunction is causally related to coronary heart disease (CHD) and stroke. Methods: Observational analyses were conducted using individual-level data from 4 population data sources (Emerging Risk Factors Collaboration, EPIC-CVD [European Prospective Investigation into Cancer and Nutrition–Cardiovascular Disease Study], Million Veteran Program, and UK Biobank), comprising 648 135 participants with no history of cardiovascular disease or diabetes at baseline, yielding 42 858 and 15 693 incident CHD and stroke events, respectively, during 6.8 million person-years of follow-up. Using a genetic risk score of 218 variants for estimated glomerular filtration rate (eGFR), we conducted Mendelian randomization analyses involving 413 718 participants (25 917 CHD and 8622 strokes) in EPIC-CVD, Million Veteran Program, and UK Biobank. Results: There were U-shaped observational associations of creatinine-based eGFR with CHD and stroke, with higher risk in participants with eGFR values 105 mL·min –1 ·1.73 m –2 , compared with those with eGFR between 60 and 105 mL·min –1 ·1.73 m –2 . Mendelian randomization analyses for CHD showed an association among participants with eGFR –1 ·1.73 m –2 , with a 14% (95% CI, 3%–27%) higher CHD risk per 5 mL·min –1 ·1.73 m –2 lower genetically predicted eGFR, but not for those with eGFR >105 mL·min –1 ·1.73 m –2 . Results were not materially different after adjustment for factors associated with the eGFR genetic risk score, such as lipoprotein(a), triglycerides, hemoglobin A1c, and blood pressure. Mendelian randomization results for stroke were nonsignificant but broadly similar to those for CHD. Conclusions: In people without manifest cardiovascular disease or diabetes, mild-to-moderate kidney dysfunction is causally related to risk of CHD, highlighting the potential value of preventive approaches that preserve and modulate kidney function.

IntroductionFatigue is one of the most commonly recorded patient symptoms that can result in deficits in aspects of psychomotor functioning, cognition, work performance and mood. Research shows that bright light and dim light therapy may be an efficacious way to reduce symptoms of fatigue. Still, the feasibility, scalability, individual treatment effects and adverse event heterogeneity of these treatments are unknown.Methods and analysisThe current study evaluates the feasibility, acceptability and effectiveness of a series of personalised (N-of-1) interventions for virtual delivery of bright light therapy and dim light therapy versus usual care treatment for fatigue in 60 participants. We hypothesise that this study will provide valuable information about implementing virtual, N-of-1 randomised controlled trials (RCTs) for fatigue. It will also offer results about determining participants’ ratings of usability and satisfaction with the virtual, personalised intervention delivery system; evaluating participants’ improvement of fatigue symptoms; and, in the long term, identify ways to integrate N-of-1 light therapy trials into patient care.Ethics and disseminationThis trial was approved by the Northwell Health Institutional Review Board. The trial results will be published in a peer-reviewed journal. All publications resulting from this series of personalised trials will follow the Consolidated Standards of Reporting Trials extension for N-of-1 trials CENT 2015 reporting guidelines.Registration detailsThis trial is registered inwww.ClinicalTrials.gov(numberNCT04707846).Trial registration numberNCT04707846.

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.

Cardiovascular disease (CVD), which includes heart disease, myocardial infarction, and stroke, is the leading cause of death in the US. A large proportion of CVD cases can be prevented by addressing modifiable risk factors, including smoking, obesity, diabetes, elevated blood pressure or hypertension, dyslipidemia, lack of physical activity, and unhealthy diet. Adults who adhere to national guidelines for a healthy diet and physical activity have lower rates of cardiovascular morbidity and mortality than those who do not; however, most US adults do not consume healthy diets or engage in physical activity at recommended levels.To update its 2017 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a review of the evidence on the benefits and harms of behavioral counseling interventions to promote healthy behaviors in adults without CVD risk factors.Adults 18 years or older without known CVD risk factors, which include hypertension or elevated blood pressure, dyslipidemia, impaired fasting glucose or glucose tolerance, or mixed or multiple risk factors such as metabolic syndrome or an estimated 10-year CVD risk of 7.5% or greater.The USPSTF concludes with moderate certainty that behavioral counseling interventions have a small net benefit on CVD risk in adults without CVD risk factors.The USPSTF recommends that clinicians individualize the decision to offer or refer adults without CVD risk factors to behavioral counseling interventions to promote a healthy diet and physical activity. (C recommendation).

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).

Cardiovascular disease (CVD) is the leading cause of mortality in the US, accounting for more than 1 in 4 deaths. Each year, an estimated 605 000 people in the US have a first myocardial infarction and an estimated 610 000 experience a first stroke.To update its 2016 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review on the effectiveness of aspirin to reduce the risk of CVD events (myocardial infarction and stroke), cardiovascular mortality, and all-cause mortality in persons without a history of CVD. The systematic review also investigated the effect of aspirin use on colorectal cancer (CRC) incidence and mortality in primary CVD prevention populations, as well as the harms (particularly bleeding) associated with aspirin use. The USPSTF also commissioned a microsimulation modeling study to assess the net balance of benefits and harms from aspirin use for primary prevention of CVD and CRC, stratified by age, sex, and CVD risk level.Adults 40 years or older without signs or symptoms of CVD or known CVD (including history of myocardial infarction or stroke) who are not at increased risk for bleeding (eg, no history of gastrointestinal ulcers, recent bleeding, other medical conditions, or use of medications that increase bleeding risk).The USPSTF concludes with moderate certainty that aspirin use for the primary prevention of CVD events in adults aged 40 to 59 years who have a 10% or greater 10-year CVD risk has a small net benefit. The USPSTF concludes with moderate certainty that initiating aspirin use for the primary prevention of CVD events in adults 60 years or older has no net benefit.The decision to initiate low-dose aspirin use for the primary prevention of CVD in adults aged 40 to 59 years who have a 10% or greater 10-year CVD risk should be an individual one. Evidence indicates that the net benefit of aspirin use in this group is small. Persons who are not at increased risk for bleeding and are willing to take low-dose aspirin daily are more likely to benefit. (C recommendation) The USPSTF recommends against initiating low-dose aspirin use for the primary prevention of CVD in adults 60 years or older. (D recommendation).

The US Preventive Services Task Force (USPSTF) works to improve the health of people nationwide by making evidence-based recommendations for preventive services. Patient-centered care is a core value in US health care. Shared decision-making (SDM), in which patients and clinicians make health decisions together, ensures patients' rights to be informed and involved in preventive care decisions and that these decisions are patient-centered. SDM has a role across the spectrum of USPSTF recommendations. For A or B recommendations (judged by the USPSTF to have high or moderate certainty of a moderate or substantial net benefit at the population level), SDM allows individual patients to decide whether to accept such services based on their personal values and preferences. For C recommendations (indicating at least moderate certainty of a small net benefit at the population level), SDM is critical for individual patients to decide whether the net benefit for them is worthwhile. For D recommendations (reflecting at least moderate certainty of a zero or negative net benefit) or I statements (low certainty of net benefit), clinicians should be prepared to discuss these services if patients ask. More evidence is needed to determine if, in addition to promoting patient-centeredness, SDM reduces inequities in preventive care, as well as to define new strategies to find time for discussion of preventive services in primary care.

Impaired sleep for hospital patients is an all too common reality. Sleep disruptions due to unnecessary overnight vital sign monitoring are associated with delirium, cognitive impairment, weakened immunity, hypertension, increased stress, and mortality. It is also one of the most common complaints of hospital patients while imposing additional burdens on healthcare providers. Previous efforts to forgo overnight vital sign measurements and improve patient sleep used providers’ subjective stability assessment or utilized an expanded, thus harder to retrieve, set of vitals and laboratory results to predict overnight clinical risk. Here, we present a model that incorporates past values of a small set of vital signs and predicts overnight stability for any given patient-night. Using data obtained from a multi-hospital health system between 2012 and 2019, a recurrent deep neural network was trained and evaluated using ~2.3 million admissions and 26 million vital sign assessments. The algorithm is agnostic to patient location, condition, and demographics, and relies only on sequences of five vital sign measurements, a calculated Modified Early Warning Score, and patient age. We achieved an area under the receiver operating characteristic curve of 0.966 (95% confidence interval [CI] 0.956–0.967) on the retrospective testing set, and 0.971 (95% CI 0.965–0.974) on the prospective set to predict overnight patient stability. The model enables safe avoidance of overnight monitoring for ~50% of patient-nights, while only misclassifying 2 out of 10,000 patient-nights as stable. Our approach is straightforward to deploy, only requires regularly obtained vital signs, and delivers easily actionable clinical predictions for a peaceful sleep in hospitals.

The purpose of the U.S. Preventive Services Task Force (USPSTF) is to provide evidence-based recommendations on primary care screening, behavioral counseling, and preventive medications. A person's health is strongly influenced by social determinants of health, such as economic and social conditions; therefore, preventive recommendations that address these determinants would be ideal. However, differing social determinants have been proposed by a wide range of agencies and organizations, little prevention evidence is available, and responsible parties are in competition, all of which make the creation of evidence-based prevention recommendations for social determinants of health challenging. This article highlights social determinants already included in USPSTF recommendations and proposes a process by which others may be considered for primary care preventive recommendations. In many ways, incorporating social determinants of health into evidence-based recommendations is an evolving area. By reviewing the evidence on the effects of screening and interventions on social determinants relevant to primary care, the USPSTF will continue to provide recommendations on clinical preventive services to improve the health of all Americans.

There is minimal information on coronavirus disease 2019 (COVID‐19) in immunocompromised individuals. We have studied 10 patients treated at 12 adult care hospitals. Ten kidney transplant recipients tested positive for severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) by polymerase chain reaction, and 9 were admitted. The median age was 57 (interquartile range [IQR] 47‐67), 60% were male, 40% Caucasian, and 30% Black/African American. Median time from transplant to COVID‐19 testing was 2822 days (IQR 1272‐4592). The most common symptom was fever, followed by cough, myalgia, chills, and fatigue. The most common chest X‐ray and computed tomography abnormality was multifocal patchy opacities. Three patients had no abnormal findings. Leukopenia was seen in 20% of patients, and allograft function was stable in 50% of patients. Nine patients were on tacrolimus and a mycophenolic antimetabolite, and 70% were on prednisone. Hospitalized patients had their antimetabolite agent stopped. All hospitalized patients received hydroxychloroquine and azithromycin. Three patients died (30%), and 5 (50%) developed acute kidney injury. Kidney transplant recipients infected with COVID‐19 should be monitored closely in the setting of lowered immunosuppression. Most individuals required hospitalization and presenting symptoms were similar to those of nontransplant individuals.

BACKGROUND: The psychological factors underlying physical inactivity in vulnerable cardiac adult populations remain understudied. Anxiety sensitivity, a cognitive vulnerability defined as fear of the physical, cognitive, and social consequences of anxiety, may be an important modifiable determinant of physical inactivity. We examined the association of anxiety sensitivity, and each anxiety sensitivity subscale (physical, cognitive, and social concerns), with physical inactivity in adults with a history of myocardial infarction (MI). METHODS: Using cross-sectional data from a nationally representative survey of adults (n=1417) in the United States who reported a health professional diagnosis of MI, we used weighted logistic regression models to evaluate the association between anxiety sensitivity (overall, and each subscale) and physical inactivity (self-reported exercise 0-1 days/week), with adjustment for age, gender, race, education, number of MIs, and depression RESULTS: Overall, 34.3% reported physical inactivity. Anxiety sensitivity was associated with greater odds of physical inactivity (OR=1.01, 95%CI:1.00,1.02, p=.026). Of the subscales, only physical concerns were associated with physical inactivity (OR=1.02, 95%CI:1.01,1.04, p=.008) in the final model. High vs. low fear of shortness of breath was most consistently associated with physical inactivity (OR=1.49 95%CI:1.08,2.06, p

The body of research on social determinants of health is rapidly accumulating. The U.S. Preventive Services Task Force is conducting evaluations to consider the inclusion of screening and counseling for social risks as a clinical preventive service. Yet, for many social risks, evidence is still likely needed before the U.S. Preventive Services Task Force can recommend universal screening or counseling. This manuscript offers a brief review of the social determinants of health that may be germane to the U.S. Preventive Services Task Force, the methods the U.S. Preventive Services Task Force uses to evaluate relevant evidence, and current evidence gaps for social risks. Key methods for making clinical preventive service recommendations are applied for considering the integration of social and clinical care. These methods include determining the certainty of the evidence, assessing the net benefit, defining appropriate prevention frameworks, defining health outcomes versus intermediate outcomes, fully assessing the harms, and defining to what populations and care contexts the evidence applies. This road map for research is intended to spark ingenuity and purpose in the next generation of research studies, thereby ensuring that future recommendations to address and prevent social risks in primary care are informed by high-quality evidence. Supplement information This article is part of a supplement entitled Identifying and Intervening on Social Needs in Clinical Settings: Evidence and Evidence Gaps, which is sponsored by the Agency for Healthcare Research and Quality of the U.S. Department of Health and Human Services, Kaiser Permanente, and the Robert Wood Johnson Foundation.

Self-regulation processes assume a major role in health behaviour theory and are postulated as important mechanisms of action in behavioural interventions to improve health prevention and management. The need to better understand mechanisms of behaviour change interventions for cardiovascular diseases (CVD) called for conducting a meta-review of meta-analyses for interventions targeting self-regulation processes. The protocol, preregistered on Open Science Framework (OSF), found 15 eligible meta-analyses, published between 2006 and August 2019, which quantitatively assessed the role of self-regulatory mechanisms and behaviour change techniques (BCTs). Quality of the meta-analyses varied widely according to AMSTAR-2 criteria. Several BCTs, assumed to engage self-regulatory mechanisms, were unevenly represented in CVD meta-analytic reviews. Self-monitoring, the most frequently studied self-regulatory BCT, seemed to improve health behaviour change and health outcomes but these results merit cautious interpretation. Findings for other self-regulatory BCTs were less promising. No studies in the CVD domain directly tested engagement of self-regulation processes. A general challenge for this area stems from reliance on post-hoc tests of the effects of BCTs in multiple-component interventions. Recent advances in BCT taxonomies and the experimental medicine approach to engaging self-regulation mechanisms, however, provide opportunities to improve CVD prevention and management behavioural interventions.

We issue a call for the design and conduct of experimental trials to test the effects of researchers' adoption of Open Science (OS) research practices. OS emerged to address lapses in the transparency, quality, integrity, and reproducibility of research by proposing that investigators institute practices, such as preregistering study hypotheses, procedures, and statistical analyses, before launching their research. These practices have been greeted with enthusiasm by some parts of the scientific community, but empirical evidence of their effects relies mainly on observational studies; furthermore, questions remain about the time and effort required by these practices and their ultimate benefit to science. To assess the outcomes of OS research practices, we propose they be viewed as behavioral interventions for scientists and tested in randomized controlled trials (RCTs), to identify potential benefits and (unintended) harms. As this is a call to action rather than an action plan per se, we sketch out four potential trial designs to encourage further deliberation and planning. Experimental tests to document the outcomes of OS practices can provide evidence to optimize how scientists, funders, policymakers, and institutions utilize these strategies to advance scientific practice. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Objective To evaluate racial and ethnic differences in mortality among patients hospitalized with coronavirus disease 2019 (COVID-19) after adjusting for baseline characteristics and comorbidities. Methods This retrospective cohort study at 13 acute care facilities in the New York City metropolitan area included sequentially hospitalized patients between March 1, 2020, and April 27, 2020. Last day of follow up was July 31, 2020. Patient demographic information, including race/ethnicity and comorbidities, were collected. The primary outcome was in-hospital mortality. Results A total of 10 869 patients were included in the study (median age, 65 years [interquartile range (IQR) 54–77; range, 18–107 years]; 40.5% female). In adjusted time-to-event analysis, increased age, male sex, insurance type (Medicare and Self-Pay), unknown smoking status, and a higher score on the Charlson Comorbidity Index were significantly associated with higher in-hospital mortality. Adjusted risk of hospital mortality for Black, Asian, Hispanic, multiracial/other, and unknown race/ethnicity patients were similar to risk for White patients. Conclusions In a large diverse cohort of patients hospitalized with COVID-19, patients from racial/ethnic minorities experienced similar mortality risk as White patients.

Key Points Question Does involvement of people with lived experience of mental illness in cofacilitation of trainings for primary care practitioners reduce stigma and improve mental health services? Findings In this pilot cluster randomized clinical trial of 88 primary care practitioners, procedures were feasible and acceptable for primary care practitioners to be trained by people with mental illness. Pilot findings suggested the potential for reduced stigma and improved diagnostic accuracy in cofacilitated training compared with standard training. Meaning These findings suggest that a full-scale trial should be conducted to evaluate sustained attitudinal improvements and improved quality of mental health services in primary care when mental health trainings are cofacilitated by people living with mental illness., This cluster randomized clinical trial investigates the feasibility and acceptability of conducting an antistigma intervention in collaboration with people with lived experience of mental illness., Importance Collaboration with people with lived experience of mental illness (PWLE), also referred to as service users, is a growing priority to reduce stigma and improve mental health care. Objective To examine feasibility and acceptability of conducting an antistigma intervention in collaboration with PWLE during mental health training of primary care practitioners (PCPs). Design, Setting, and Participants This pilot cluster randomized clinical trial was conducted from February 7, 2016, to August 10, 2018, with assessors, PCPs, and patients blinded to group assignment. The participants were PCPs and primary care patients diagnosed with depression, psychosis, or alcohol use disorder at primary care facilities (the cluster unit of randomization) in Nepal. Statistical analysis was performed from February 2020 to February 2021. Interventions In the control group, PCPs were trained on the World Health Organization Mental Health Gap Action Programme-Intervention Guide (mhGAP-IG). In the Reducing Stigma Among Healthcare Providers (RESHAPE) group, the mhGAP-IG trainings for PCPs were cofacilitated by PWLE who presented recovery testimonials through photographic narratives. Main Outcomes and Measures Prespecified feasibility and acceptability measures were adequacy of randomization, retention rates, intervention fidelity, data missingness, and safety. Outcome measures for PCPs included the Social Distance Scale (SDS), accuracy of diagnoses of mental illness in standardized role-plays using the Enhancing Assessment of Common Therapeutic factors tool (ENACT), and accuracy of diagnosis with actual patients. The primary end point was 16 months posttraining. Results Among the overall sample of 88 PCPs, 75 (85.2%) were men and 67 (76.1%) were upper caste Hindus; the mean (SD) age was 36.2 (8.8) years. Nine of the PCPs (10.2%) were physicians, whereas the remaining 79 PCPs (89.8%) were health assistants or auxiliary health workers. Thirty-four facilities were randomized to RESHAPE or the control group. All eligible PCPs participated: 43 in RESHAPE and 45 in the control group, with 76.7% (n = 33) and 73.3% (n = 33) retention at end line, respectively. Due to PCP dropout, 29 facilities (85.3%) were included in end line analysis. Of 15 PWLE trained as cofacilitators, 11 (73.3%) participated throughout the 3 months of PCP trainings. Among PCPs, mean SDS changes from pretraining to 16 months were −10.6 points (95% CI, −14.5 to −6.74 points) in RESHAPE and −2.79 points (−8.29 to 2.70 points) in the control group. Role-play–based diagnoses with ENACT were 78.1% (25 of 32) accurate in RESHAPE and 66.7% (22 of 33) in the control group. Patient diagnoses were 72.5% (29 of 40) accurate by PCPs in RESHAPE compared with 34.5% (10 of 29) by PCPs in the control group. There were no serious adverse events. Conclusions and Relevance This pilot cluster randomized clinical trial found that procedures were feasible and acceptable for PCPs to be trained by PWLE. These pilot results will help inform a full trial to evaluate benefits of collaboration with PWLE during training of PCPs to reduce stigma and improve diagnostic accuracy. Trial Registration ClinicalTrials.gov Identifier: NCT02793271

Background Age has been implicated as the main risk factor for COVID-19-related mortality. Our objective was to utilize administrative data to build an explanatory model accounting for geriatrics-focused indicators to predict mortality in hospitalized older adults with COVID-19. Methods Retrospective cohort study of adults age 65 and older (N = 4783) hospitalized with COVID-19 in the greater New York metropolitan area between 3/1/20-4/20/20. Data included patient demographics and clinical presentation. Stepwise logistic regression with Akaike Information Criterion minimization was used. Results The average age was 77.4 (SD = 8.4), 55.9% were male, 20.3% were African American, and 15.0% were Hispanic. In multivariable analysis, male sex (adjusted odds ration (adjOR) = 1.06, 95% CI:1.03-1.09); Asian race (adjOR = 1.08, CI:1.03-1.13); history of chronic kidney disease (adjOR = 1.05, CI:1.01-1.09) and interstitial lung disease (adjOR = 1.35, CI:1.28-1.42); low or normal body mass index (adjOR:1.03, CI:1.00-1.07); higher comorbidity index (adjOR = 1.01, CI:1.01-1.02); admission from a facility (adjOR = 1.14, CI:1.09-1.20); and mechanical ventilation (adjOR = 1.52, CI:1.43-1.62) were associated with mortality. While age was not an independent predictor of mortality, increasing age (centered at 65) interacted with hypertension (adjOR = 1.02, CI:0.98-1.07, reducing by a factor of 0.96 every 10 years); early Do-Not-Resuscitate (DNR, life-sustaining treatment preferences) (adjOR = 1.38, CI:1.22-1.57, reducing by a factor of 0.92 every 10 years); and severe illness on admission (at 65, adjOR = 1.47, CI:1.40-1.54, reducing by a factor of 0.96 every 10 years). Conclusion Our findings highlight that residence prior to admission, early DNR, and acute illness severity are important predictors of mortality in hospitalized older adults with COVID-19. Readily available administrative geriatrics-focused indicators that go beyond age can be utilized when considering prognosis.