Relationship between device acceptance and patient-reported outcomes in left ventricular assist device (LVAD) recipients

The number of Left Ventricular Assist Devices (LVADs) implanted each year is rising. Nevertheless, there are minimal data on device acceptance after LVAD implant, and on its relationship with patient-reported outcomes. We designed a cross-sectional study to address this knowledge gap and test the hypothesis that low device acceptance is associated with poorer quality of life, depression and anxiety. Self-report questionnaires were administered to assess quality of life (12-item Kansas City Cardiomyopathy Questionnaire quality of life subscale), level of anxiety (7-item Generalized Anxiety Disorder; GAD-7), level of depression (9-item Patient Health Questionnaire; PHQ-9) and device acceptance (Florida Patient Acceptance Survey; FPAS) to 101 consecutive patients presenting to LVAD clinic. Regression analysis showed a strong correlation between device acceptance and both psychological distress (p\u2009<\u20090.001) and quality of life (p\u2009<\u20090.001). Analysis of the sub-scales of the FPAS showed that patients had significant body image concerns, but return to function and device-related distress were the main drivers of the observed correlation between device acceptance and patient well-being. Younger age was associated with lower device acceptance (r\u2009=\u20090.36, p\u2009<\u20090.001) and lower quality of life (r\u2009=\u20090.54, p\u2009<\u20090.001). These findings suggest that interventions targeting device acceptance should be explored to improve outcomes in LVAD recipients

Addressing cancer survivors\u27 cardiovascular health using the Automated Heart Health Assessment (AH-HA) EHR tool: Initial protocol and modifications to address COVID-19 challenges

BACKGROUND: The purpose of this paper is to describe the Automated Heart-Health Assessment (AH-HA) study protocol, which demonstrates an agile approach to cancer care delivery research. This study aims to assess the effect of a clinical decision support tool for cancer survivors on cardiovascular health (CVH) discussions, referrals, completed visits with primary care providers and cardiologists, and control of modifiable CVH factors and behaviors. The COVID-19 pandemic has caused widespread disruption to clinical trial accrual and operations. Studies conducted with potentially vulnerable populations, including cancer survivors, must shift towards virtual consent, data collection, and study visits to reduce risk for participants and study staff. Studies examining cancer care delivery innovations may also need to accommodate the increased use of virtual visits. METHODS/DESIGN: This group-randomized, mixed methods study will recruit 600 cancer survivors from 12 National Cancer Institute Community Oncology Research Program (NCORP) practices. Survivors at intervention sites will use the AH-HA tool with their oncology provider; survivors at usual care sites will complete routine survivorship visits. Outcomes will be measured immediately after the study visit, with follow-up at 6 and 12 months. The study was amended during the COVID-19 pandemic to allow for virtual consent, data collection, and intervention options, with the goal of minimizing participant-staff in-person contact and accommodating virtual survivorship visits. CONCLUSIONS: Changes to the study protocol and procedures allow important cancer care delivery research to continue safely during the COVID-19 pandemic and give sites and survivors flexibility to conduct study activities in-person or remotely

Evaluating the efficacy of a social media-based intervention (Warna-Warni Waktu) to improve body image among young Indonesian women: Parallel randomized controlled trial

BACKGROUND: Body dissatisfaction is a global issue, particularly among adolescent girls and young women. Effective body image interventions exist but face barriers to scaling up, particularly in lower- and middle-income countries, such as Indonesia, where a need exists. OBJECTIVE: We aimed to evaluate the acceptability and efficacy of Warna-Warni Waktu, a social media-based, fictional 6-episode video series with self-guided web-based activities for improving body image among young Indonesian adolescent girls and young women. We hypothesized that Warna-Warni Waktu would increase trait body satisfaction and mood and decrease internalization of appearance ideals and skin shade dissatisfaction relative to the waitlist control condition. We also anticipated improvements in state body satisfaction and mood immediately following each video. METHODS: We conducted a web-based, 2-arm randomized controlled trial among 2000 adolescent girls and young women, aged 15 to 19 years, recruited via telephone by an Indonesian research agency. Block randomization (1:1 allocation) was performed. Participants and researchers were not concealed from the randomized arm. Participants completed self-report assessments of trait body satisfaction (primary outcome) and the internalization of appearance ideals, mood, and skin shade dissatisfaction at baseline (before randomization), time 2 (1 day after the intervention [T2]), and time 3 (1 month after the intervention [T3]). Participants also completed state body satisfaction and mood measures immediately before and after each video. Data were evaluated using linear mixed models with an intent-to-treat analysis. Intervention adherence was tracked. Acceptability data were collected. RESULTS: There were 1847 participants. Relative to the control condition (n=923), the intervention group (n=924) showed reduced internalization of appearance ideals at T2 (F1,1758=40.56, P<.001, partial η2=0.022) and T3 (F1,1782=54.03, P<.001, partial η2=0.03) and reduced skin shade dissatisfaction at T2 (F1,1744=8.05, P=.005, partial η2=0.005). Trait body satisfaction improvements occurred in the intervention group at T3 (F1, 1781=9.02, P=.005, partial η2=0.005), which was completely mediated by the internalization change scores between baseline and T2 (indirect effect: β=.03, 95% CI 0.017-0.041; direct effect: β=.03, P=.13), consistent with the Tripartite Influence Model of body dissatisfaction. Trait mood showed no significant effects. Dependent sample t tests (2-tailed) found each video improved state body satisfaction and mood. Cumulative analyses found significant and progressive improvements in pre- and poststate body satisfaction and mood. Intervention adherence was good; participants watched an average of 5.2 (SD 1.66) videos. Acceptability scores were high for understandability, enjoyment, age appropriateness, usefulness, and likelihood to recommend. CONCLUSIONS: Warna-Warni Waktu is an effective eHealth intervention to reduce body dissatisfaction among Indonesian adolescent girls and young women. Although the effects were small, Warna-Warni Waktu is a scalable, cost-effective alternative to more intense interventions. Initially, dissemination through paid social media advertising will reach thousands of young Indonesian women. TRIAL REGISTRATION: ClinicalTrials.gov NCT05383807, https://clinicaltrials.gov/ct2/show/NCT05383807 ; ISRCTN Registry ISRCTN35483207, https://www.isrctn.com/ISRCTN35483207. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/33596

A novel, scalable social media-based intervention Warna-Warni Waktu to reduce body dissatisfaction among young Indonesian women: Protocol for a parallel randomized controlled trial

Background: Despite the prevalence of body dissatisfaction among young Indonesian women and its consequential negative impacts, there are currently no evidence-based, culturally appropriate interventions to tackle this issue. Therefore, there is a need to develop scalable, cost-effective, and accessible interventions to improve body image among this population. Objective: This paper describes the study protocol of a parallel randomized controlled trial to evaluate the effectiveness of Warna-Warni Waktu, a social media–based intervention that aims to reduce state and trait body dissatisfaction and improve mood among young Indonesian women aged 15-19 years. Methods: The trial will take place online. Approximately 1800 young women from 10 cities in Indonesia, evenly split across the ages of 15-19 years, will be recruited via a local research agency’s established research panel. Participants will be randomly allocated to the intervention condition or a waitlist control condition. The intervention consists of six 5-minute videos, with each video supplemented with up to five brief interactive activities. The videos (and associated activities) will be delivered at a rate of one per day across 6 days. All participants will complete three self-report assessments: at baseline (Day 1), 1 day following the intervention (Day 9), and 1 month following the intervention (Day 36). The primary outcome will be change in trait body dissatisfaction. Secondary outcomes include change in internalization of appearance ideals, trait mood, and skin shade satisfaction. Intervention effectiveness on these outcomes will be analyzed using linear mixed models by a statistician blinded to the randomized condition. Intervention participants will also complete state measures of body satisfaction and mood before and after watching each video to assess the immediate impact of each video. This secondary analysis of state measures will be conducted at the within-group level. Results: Recruitment began in October 2021, with baseline assessments underway shortly thereafter. The results of the study will be submitted for publication in 2022. Conclusions: This is the first study to evaluate an eHealth intervention aimed at reducing body dissatisfaction among young Indonesian women. If effective, the intervention will be disseminated to over half a million young women in Indonesia via Facebook, Instagram, and YouTube. Trial Registration: ClinicalTrials.gov NCT05023213; https://clinicaltrials.gov/ct2/show/NCT05023213 International Registered Report Identifier (IRRID): PRR1-10.2196/33596

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Engaging Persons From Lay Social Networks in Heart Failure Symptom Evaluation

The aim of this project was to describe patient perceptions of seeking lay advice from persons in their social network for symptom evaluation prior to hospitalization for acute decompensated heart failure

Evaluating a school-based body image lesson in Indonesia: A randomised controlled trial.

Negative body image is a common public health concern among adolescents, globally. The aim of the current study was to evaluate the effectiveness, implementation fidelity, and acceptability of a single session, school-based universal body image intervention in Indonesia. A total of 1926 adolescents (59.4 % girls) and 12 school guidance counsellors (lesson facilitators) from nine state junior secondary schools in Surabaya, East Java took part in a two-arm open parallel cluster randomised controlled trial. In response to the changing circumstances due to the COVID-19 pandemic, half of the lessons were conducted in person and half were delivered online. Results showed that the lesson did not significantly improve adolescent body image or secondary outcomes relative to the control, though there was no evidence of harm. There were no substantive findings regarding intervention effectiveness by gender. The mode of intervention delivery (online vs. in-person) did not significantly influence the main findings. Implementation fidelity varied widely, and the lesson content and pedagogy were largely acceptable, though there was a strong preference for in-person lesson delivery. Findings have implications for researchers aiming to improve adolescent body image in low- and middle-income countries. Lessons learned can inform future school-based efforts to support adolescent body image. [Abstract copyright: Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.

Cardiovascular health assessment in routine cancer follow-up in community settings: survivor risk awareness and perspectives

Abstract Background Guidelines recommend cardiovascular risk assessment and counseling for cancer survivors. For effective implementation, it is critical to understand survivor cardiovascular health (CVH) profiles and perspectives in community settings. We aimed to (1) Assess survivor CVH profiles, (2) compare self-reported and EHR-based categorization of CVH factors, and (3) describe perceptions regarding addressing CVH during oncology encounters. Methods This cross-sectional analysis utilized data from an ongoing NCI Community Oncology Research Program trial of an EHR heart health tool for cancer survivors (WF-1804CD). Survivors presenting for routine care after potentially curative treatment recruited from 8 oncology practices completed a pre-visit survey, including American Heart Association Simple 7 CVH factors (classified as ideal, intermediate, or poor). Medical record abstraction ascertained CVD risk factors and cancer characteristics. Likert-type questions assessed desired discussion during oncology care. Results Of 502 enrolled survivors (95.6% female; mean time since diagnosis = 4.2 years), most had breast cancer (79.7%). Many survivors had common cardiovascular comorbidities, including high cholesterol (48.3%), hypertension or high BP (47.8%) obesity (33.1%), and diabetes (20.5%); 30.5% of survivors received high cardiotoxicity potential cancer treatment. Less than half had ideal/non-missing levels for physical activity (48.0%), BMI (18.9%), cholesterol (17.9%), blood pressure (14.1%), healthy diet (11.0%), and glucose/ HbA1c (6.0%). While > 50% of survivors had concordant EHR-self-report categorization for smoking, BMI, and blood pressure; cholesterol, glucose, and A1C were unknown by survivors and/or missing in the EHR for most. Most survivors agreed oncology providers should talk about heart health (78.9%). Conclusions Tools to promote CVH discussion can fill gaps in CVH knowledge and are likely to be well-received by survivors in community settings. Trial registration NCT03935282, Registered 10/01/202

Addressing cancer survivors’ cardiovascular health using the automated heart health assessment (AH-HA) EHR tool: Initial protocol and modifications to address COVID-19 challenges

Background: The purpose of this paper is to describe the Automated Heart-Health Assessment (AH-HA) study protocol, which demonstrates an agile approach to cancer care delivery research. This study aims to assess the effect of a clinical decision support tool for cancer survivors on cardiovascular health (CVH) discussions, referrals, completed visits with primary care providers and cardiologists, and control of modifiable CVH factors and behaviors. The COVID-19 pandemic has caused widespread disruption to clinical trial accrual and operations. Studies conducted with potentially vulnerable populations, including cancer survivors, must shift towards virtual consent, data collection, and study visits to reduce risk for participants and study staff. Studies examining cancer care delivery innovations may also need to accommodate the increased use of virtual visits. Methods/design: This group-randomized, mixed methods study will recruit 600 cancer survivors from 12 National Cancer Institute Community Oncology Research Program (NCORP) practices. Survivors at intervention sites will use the AH-HA tool with their oncology provider; survivors at usual care sites will complete routine survivorship visits. Outcomes will be measured immediately after the study visit, with follow-up at 6 and 12 months. The study was amended during the COVID-19 pandemic to allow for virtual consent, data collection, and intervention options, with the goal of minimizing participant-staff in-person contact and accommodating virtual survivorship visits. Conclusions: Changes to the study protocol and procedures allow important cancer care delivery research to continue safely during the COVID-19 pandemic and give sites and survivors flexibility to conduct study activities in-person or remotely