Clinical research reactivation during the COVID-19 pandemic: An academic center process and lessons for the future.

Background: Clinical research is a central mission of the University of Colorado Anschutz Medical Campus (CU-Anschutz). On March 18, 2020, due to rising COVID-19 rates and personal protective equipment (PPE) shortages, an emergency approval process for critical research essential to the care and safety of patients, including COVID-19 trials, was enacted. All other clinical research studies requiring face-to-face visits were placed on hold to protect participant and staff safety. Methods: A clinical research TaskForce was rapidly assembled, consisting of a cross- section of campus clinical research operations leaders, including affiliate hospitals. This group developed a guidance document and process where the primary prioritization factor was positive therapeutic benefit/risk (Groups 2-5). A REDCap form demarcating items including research visit types and safety plans was designed. A separate Space Plan Committee approval was required to gauge environmental health and safety. Results: A total of 654 protocols were approved over 31 weeks using this process. Group 2 review and approvals occurred within 5 days of campus reactivation, and 65 days after original clinical research hold. Groups 3 through 5 were opened for submission and review in a phased approach. The majority proactively submitted IRB protocol amendments to minimize face-to-face participant/staff contact. There were no cases of COVID-19 outbreak in research participants. Conclusion: Clinical research reactivation was rapidly implemented in a transparent, collaborative, broadly supported, and efficient process of staged reactivation while prioritizing the health and safety of participants and staff at CU-Anschutz. This model is practical and easily generalizable to other medical research campuses.

Reproductive and contraceptive counseling received by adult women with congenital heart disease: a risk-based analysis.

BACKGROUND/OBJECTIVE: Our aim was to study the prevalence of counseling received by adult women with congenital heart disease to determine from whom they received such counseling and to describe their contraceptive and reproductive knowledge. METHODS/DESIGN: Using a cross-sectional survey, information was collected from 83 women, ≥ 19 years of age with congenital heart disease from a group of 404 women followed in our adult congenital heart disease clinic. Women were stratified into combined hormonal contraceptive and pregnancy World Health Organization risk classes 1-4 based on cardiac lesion. RESULTS: We hypothesized that >50% of women had not received both contraceptive and reproductive counseling that addressed their heart condition; indeed, 59% of women reported they had not received such counseling (P=.05). Women who had received heart-specific contraceptive counseling were in higher risk combined hormonal contraceptive World Health Organization classes (P=.02). Similarly, women who reported receiving counseling regarding risks of pregnancy were also in higher pregnancy World Health Organization risk classes (P=.002). Fifty-two of 77 women (63%) did not know if there was a contraindicated contraceptive method given their underlying heart condition; 16 of these 52 women (31%) were combined hormonal contraceptive class 3 or class 4. CONCLUSIONS: This adult congenital heart disease survey study demonstrates an opportunity to improve individualized contraceptive and reproductive counseling with a goal toward minimizing each patient's risk of potentially avoidable adverse events. A stronger collaboration among health care professionals is needed to increase the prevalence of heart-specific counseling and to increase the quality of counseling these women are receiving.

Ultrasound contrast and real-time perfusion in conjunction with supine bicycle stress echocardiography for comprehensive evaluation of surgically corrected congenital heart disease.

AIMS: We sought to evaluate the efficacy of ultrasound contrast (UC) and low mechanical index real-time perfusion (RTP) in the haemodynamic and anatomic assessment of repaired congenital heart disease (CHD) at rest and during supine bicycle stress echocardiography (BSE). METHODS AND RESULTS: Patients with CHD (n = 51, median age 21.5 years) were prospectively studied. All had compromised image quality, 20 (39%) had arrhythmias, and 10 (20%) had pacemakers. RTP was performed at rest and during BSE using Definity and Contrast Pulse Sequencing, with assessment of Doppler pressure gradients. Diagnoses included tetralogy of Fallot (n = 27), transposition of the great arteries (TGA) atrial switch (n = 10), TGA arterial switch (n = 2), aortic valve disease (n = 4), Fontan (n = 4), and Kawasaki disease (n = 4). UC with RTP improved endocardial border definition, with increased number of left ventricular (LV) and right ventricular (RV) segments visualized at rest (P < 0.0001) and during stress. LV ejection fraction (EF) and RV fractional area change (FAC) were measurable at rest and peak stress, RV FAC correlating closely with same-day magnetic resonance EFs (r = 0.72; P < 0.001). UC enhanced Doppler signals, enabling subpulmonary ventricular systolic pressure measurements at rest and stress. In six patients, marked elevations of subpulmonary ventricular systolic pressure were detected with UC during BSE, and quantifiable ventricular dysfunction. No adverse events occurred, other than transient low back pain in one patient. CONCLUSION: UC at rest and with supine BSE enables safe and comprehensive assessment of anatomy, haemodynamics, and biventricular functional and perfusion reserve in adolescents and young adults with surgically modified CHD.