Consensus recommendations for measuring the impact of contraception on the menstrual cycle in contraceptive clinical trials.

Objective: We sought to develop consensus recommendations for measurement and analysis of data on contraceptive-induced menstrual changes (CIMCs) in contraceptive clinical trials. We built upon previous standardization efforts over the last 50 years and prioritized input from a variety of global experts and current regulatory authority guidance on patient-reported outcomes.

Study Design: We completed a formal consensus-building process with an interdisciplinary group of 57 experts from 30 organizations and 14 countries in five global regions who work across academia, nonprofit research organizations, the pharmaceutical industry, and funding agencies.

Civic identity: media, belonging, & Latiné youth in the 2020 US presidential election.

We explore how Latiné immigrant-origin youth used and made sense of media to enact their civic identities during the 2020 US presidential election cycle. In a polarized national context, this project highlights the voices and experiences of the participants (n=39). We conducted and analysed semi-structured interviews to identify three comprehensive themes.

Biomechanical modeling combined with pressure-volume loop analysis to aid surgical planning in patients with complex congenital heart disease.

Patients with congenitally corrected transposition of the great arteries (ccTGA) can be treated with a double switch operation (DSO) to restore the normal anatomical connection of the left ventricle (LV) to the systemic circulation and the right ventricle (RV) to the pulmonary circulation. The subpulmonary LV progressively deconditions over time due to its connection to the low pressure pulmonary circulation and needs to be retrained using a surgical pulmonary artery band (PAB) for 6-12 months prior to the DSO. The subsequent clinical follow-up, consisting of invasive cardiac pressure and non-invasive imaging data, evaluates LV preparedness for the DSO.

Response of health-related quality of life following pediatric/congenital cardiac catheterization procedures.

Background: Health related quality of life (HRQOL) is a patient-reported metric (PRM) that provides a holistic measure of health that is not addressed in traditional outcome measures. The acute responsiveness of HRQOL after pediatric/congenital cardiac catheterization procedures has not, to our knowledge, been studied.

Methods: A single-center prospective cohort study was performed, longitudinally evaluating HRQOL and other PRM in school-age children and adolescents (ages 8-18) undergoing diagnostic and interventional cardiac catheterization procedures prior to their scheduled procedure, and then 1 day, ∼1 month, and ∼3 months after the procedure.