No abstract

No abstract

Approximately one-third of clinical trials fail to meet their recruitment goals, which can cause costly delays to sponsors and compromise the scientific integrity and generalizability of a trial. Inadequate recruitment and retention of patient groups who have the disease under investigation may produce insufficient medical knowledge about the therapeutic effects of drugs or products for the population at large. It is essential to address these issues to ensure that certain groups are not unduly subjected to disproportionate risks or denied the benefits of research. This commentary will present opportunities for clinical trialists to use emerging technologies and decentralized approaches to improve clinical trial recruitment, mitigate disparities, and improve individual and population-level outcomes within cardiovascular medicine.

Objective: Cognitive measures are an important primary outcome of pediatric, adolescents, and childhood epilepsy surgery. The purpose of this systematic review and meta-analysis is to assess whether there are long-term alterations (≥ 5 years) in the Full-Scale Intelligence Quotient (FSIQ) of pediatric patients undergoing epilepsy surgery. Methods: Electronic databases (EMBASE, MEDLINE, and Scopus) were searched for English articles from inception to October 2022 that examined intelligence outcomes in pediatric epilepsy surgery patients. Inclusion criteria were defined as the patient sample size of ≥ 5, average follow- up of ≥5 years, and surgeries performed on individuals ≤ 18 years old at the time of surgery. Exclusion criteria consisted of palliative surgery, animal studies, and studies not reporting surgical or FSIQ outcomes. Publication bias was assessed using a funnel plot and the Quality in Prognosis Studies (QUIPS) toolset was used for quality appraisal of the selected articles. A random- effects network meta-analysis was performed to compare FSIQ between surgical patients at baseline and follow-up and Mean Difference (MD) was used to calculate the effect size of each study. Point estimates for effects and 95% confidence intervals for moderation analysis were performed on variables putatively associated with the effect size. Results: 21,408 studies were screened for abstract and title. Of these, 797 fit our inclusion and exclusion criteria and proceeded to full-text screening. Overall, seven studies met our requirements and were selected. Quantitative analysis was performed on these studies (N = 330). The mean long-term difference between pre- and post- operative FSIQ scores across all studies was noted at 3.36 [95% CI: (0.14, 6.57), p = 0.04, I2 = 0%] and heterogeneity was low. Conclusion: To our knowledge, this is the first meta-analysis to measure the long-term impacts of FSIQ in pediatric and adolescent epilepsy patients. Our overall results in this meta-analysis indicate that while most studies do not show long-term FSIQ deterioration in pediatric patients who underwent epilepsy surgery, the observed changes were not clinically significant. Moreover, at the individual patient level analysis, while most children did not show long-term FSIQ deterioration, few had significant decline. These findings indicate the importance of surgery as a viable option for pediatric patients with medically refractory epilepsy.

Introduction: Despite overwhelming evidence that guideline-directed medical therapies (GDMT) for heart failure (HF) can reduce mortality and improve quality of life, significant gaps in treatment optimization persist. GDMT initiation and up-titration are especially critical for improving patient outcomes post-hospitalization. Objective: Identify challenges encountered post-hospitalization in optimizing GDMT for HF management by engaging key stakeholders in human-centered design (HCD) to guide the development of a digital toolkit to increase HF GDMT optimization. Methods: HCD is used to solve complex problems by soliciting input from stakeholders. We recruited: a) clinicians (physicians and advanced practice providers) who provide care to patients with HF across three health systems, b) patients with HF with Reduced Ejection Fraction (HFrEF, EF < 40%) discharged from the hospital within 30 days of enrollment, and c) patient health partners when available. We conducted separate virtual sessions for clinicians and patients/health partners using semi-structured interview guides to identify challenges, motivators and themes. Results: We enrolled 10 clinicians, 10 patients, and 2 patient health partners. The clinicians had a median age of 37 years (IQR: 35-41) and 12 years (IQR: 14-9) experience caring for patients with HF; 80% (8/10) were women, and 50% (5/10) were physicians. Patients had a median age of 53 years (IQR: 48-64); 40% (4/10) were women, 60% (6/10) were a racial/ethnic minority, and 50% (5/10) were married. Top challenges to HF GDMT optimization (e.g. number of medications) and digital toolkit features identified during the clinician HCD sessions are reported in Figure 1. Conclusions: The clinician and patient/health partner HCD findings will inform the development of the digital toolkit, including a patient-facing smartphone application and clinician dashboard, for HF GDMT optimization. We will also conduct HCD sessions in Brazil to further co-design the digital toolkit for low resource settings.