Patient Perspectives on Digital Interventions to Manage Heart Failure Medications: The VITAL-HF Pilot.

Use of guideline-directed medical therapy (GDMT) for treatment of heart failure with reduced ejection fraction (HFrEF) remains unacceptably low. The purpose of this study was to determine whether a digital health tool can augment GDMT for patients with HFrEF. Participants ≥ 18 years old with symptomatic HFrEF (left ventricular ejection fraction ≤ 40%) and with access to a mobile phone with internet were included. Participants were given a blood pressure cuff, instructed in its use, and given regular symptom surveys via cell-phone web-link. Data were transmitted to the Story Health web-based platform, and automated alerts were triggered based on pre-specified vital sign and laboratory data. Health coaches assisted patients with medication education, pharmacy access, and lab access through text messages and phone calls. GDMT titration plans were individually created in the digital platform by local clinicians based on entry vitals and labs. Twelve participants enrolled and completed the study. The median age and LVEF were 52.5 years (IQR, 46.5-63.5) and 25% (IQR, 22.5-35.5), respectively. There were 10 GDMT initiations, 52 up-titrations, and 13 down-titrations. Five participants engaged in focus-group interviews following study completion to understand first-hand perspectives regarding the use of digital tools to manage GDMT. Participants expressed comfort knowing that there were clinicians regularly reviewing their data. This alleviated concerns of uncertainty in daily living, led to an increased feeling of security, and empowered patients to understand decision-making regarding GDMT. Frequent medication changes, and the associated financial impact, were common concerns. Remote titration of GDMT for HFrEF is feasible and appears to be a patient-centered approach to care.

Adapting the Evidence Academy model for virtual stakeholder engagement in a national setting during the COVID-19 pandemic.

The COVID-19 pandemic raised the importance of adaptive capacity and preparedness when engaging historically marginalized populations in research and practice. The Rapid Acceleration of Diagnostics in Underserved Populations' COVID-19 Equity Evidence Academy Series (RADx-UP EA) is a virtual, national, interactive conference model designed to support and engage community-academic partnerships in a collaborative effort to improve practices that overcome disparities in SARS-CoV-2 testing and testing technologies. The RADx-UP EA promotes information sharing, critical reflection and discussion, and creation of translatable strategies for health equity. Staff and faculty from the RADx-UP Coordination and Data Collection Center developed three EA events with diverse geographic, racial, and ethnic representation of attendees from RADx-UP community-academic project teams: February 2021 (n = 319); November 2021 (n = 242); and September 2022 (n = 254). Each EA event included a data profile; 2-day, virtual event; event summary report; community dissemination product; and an evaluation strategy. Operational and translational delivery processes were iteratively adapted for each EA across one or more of five adaptive capacity domains: assets, knowledge and learning, social organization, flexibility, and innovation. The RADx-UP EA model can be generalized beyond RADx-UP and tailored by community and academic input to respond to local or national health emergencies.

Construct validity of Patient-Reported Outcomes Measurement Information System Paediatric measures in juvenile idiopathic arthritis and systemic lupus erythematosus: cross-sectional evaluation.

OBJECTIVES: Evaluate construct validity of Patient-Reported Outcomes Measurement Information System (PROMIS) Paediatric measures of symptoms and functioning against measures of disease activity among youth with juvenile idiopathic arthritis (JIA) or systemic lupus erythematosus (SLE). DESIGN: Cross-sectional associations among PROMIS measures and clinical metrics of disease activity were estimated. SETTING: Seven clinical sites of the Childhood Arthritis and Rheumatology Alliance (CARRA) in the USA. PARTICIPANTS: Youth aged 8-17 years enrolled in the CARRA Registry. INTERVENTION: PROMIS measures were collected and associations with clinical measures of disease activity estimated, by condition, in bivariate and multivariable analyses with adjustment for sociodemographics, insurance status, medications and disease duration. MAIN OUTCOME MEASURES: PROMIS Paediatric measures of mobility, physical activity, fatigue, pain interference, family relationships, peer relationships, depressive symptoms, psychological stress, anxiety, and meaning and purpose, and clinical metrics of disease. RESULTS: Among 451 youth (average age 13.8 years, 71% female), most (n=393, 87%) had a JIA diagnosis and the remainder (n=58, 13%) had SLE. Among participants with JIA, those with moderate/high compared with low/inactive disease had, on average, worse mobility (multivariable regression coefficient and 95% CIs) (-7.40; -9.30 to -5.50), fatigue (3.22; 1.02 to 5.42), pain interference (4.76; 3.04 to 6.48), peer relationships (-2.58; -4.52 to -1.64), depressive symptoms (3.00; 0.96 to 5.04), anxiety (2.48; 0.40 to 4.56) and psychological stress (2.52; 0.68 to 4.36). For SLE, youth with active versus inactive disease had on average worse mobility (-5.07; -10.15 to 0.01) but PROMIS Paediatric measures did not discriminate participants with active and inactive disease in adjusted analyses. CONCLUSIONS: Seven PROMIS Paediatric measures discriminated between active and inactive disease in youth with JIA. Results advance the usefulness of PROMIS for understanding well-being and improving interventions for youth with JIA, but larger studies are needed to determine utility in SLE cohorts. TRIAL REGISTRATION NUMBER: National Institute of Arthritis and Musculoskeletal and Skin Diseases (U19AR069522).

Design of the Healthcare Worker Exposure Response and Outcomes (HERO) research platform.

BACKGROUND: The SARS CoV-2 virus has caused one of the deadliest pandemics in recent history, resulting in over 170 million deaths and global economic disruption. There remains an urgent need for clinical trials to test therapies for treatment and prevention. DESIGN: An online research platform was created to support a registry community of healthcare workers (HCWs) to understand their experiences and conduct clinical studies to address their concerns. The first study, HERO-HCQ, was a double-blind, multicenter, randomized, pragmatic trial to evaluate the superiority of hydroxychloroquine (HCQ) vs placebo for pre-exposure prophylaxis (PrEP) of COVID-19 clinical infection in HCWs. Secondary objectives were to assess the efficacy of HCQ in preventing viral shedding of COVID-19 among HCWs and to assess the safety and tolerability of HCQ. METHODS: HCWs joined the Registry and were pre-screened for trial interest and eligibility. Trial participants were randomized 1:1 to receive HCQ or placebo. On-site baseline assessment included a COVID-19 nasopharyngeal PCR and blood serology test. Weekly follow-up was done via an online portal and included screening for symptoms of COVID-19, self-reported testing, adverse events, and quality of life assessments. The on-site visit was repeated at Day 30. DISCUSSION: The HERO research platform offers an approach to rapidly engage, screen, invite and enroll into clinical studies using a novel participant-facing online portal interface and remote data collection, enabling limited onsite procedures for conduct of a pragmatic clinical trial. This platform may be an example for future clinical trials of common conditions to enable more rapid evidence generation.