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Journal of Cystic Fibrosis ; 21(Supplement 2):S57, 2022.
Article in English | EMBASE | ID: covidwho-2315359


Background: Medical teams are experiencing unprecedented stressors as a result of the COVID-19 pandemic. In the face of these pressures, teamwork has become more important and more challenging. Focused attention on teamwork is required. Cystic fibrosis clinical research programs across the country have struggled with team dynamics during the pandemic, and attention to how the team interacts is important. The clinical research program in pediatric pulmonary disease at Rainbowconsisted of two teams (cystic fibrosis (CF), asthma and other pulmonary disease). We identified the struggle during the pandemic of losing touch with our team because of staggered schedules, the way studies were assigned, and separation of the teams in the program. Research coordinators (RCs) were working in silos that led to one RC being very busy while others might not be busy. A survey of four RCs revealed that the top four challenges they faced as individuals were completing tasks effectively, work distribution, communication, and lack of transparency. The top three challenges they faced as a team were communication, doing things "on the fly" (not planning ahead), and workload equity between team members. Method(s): The objective was to create an environment in which everyone worked together for a common goal: advancing clinical trials to support our patients through improved team dynamics with a shared vision. To accomplish this goal, we adapted our research program to include staff from all of the Pediatric Pulmonology Disease Division, allowing us to have six RCs who can move between multiple studies. The clinical research operations manager (CROM) assigns the teams during study startup. Teams of three RCs and one regulatory coordinator are assigned to each study. During startup, delegation of responsibilities is decided with the aid of a startup and implementation checklist. The three-person teams rotate to allowall team members to work with and support each other. The RCs have no regulatory responsibilities, and the Support Services team meets most processing needs. Weekly huddles are held to review visits and discuss coverage and logistics for the upcoming week. To further develop the team dynamic, a huddle is reservedweekly to reviewa study or logistics of a new or ongoing study. The entire team also meetsweekly, including the primary investigators, to review the status of studies at various stages of the clinical research cycle. Result(s): The pediatric pulmonary team model was implemented in September 2021;since then, 13 studies have migrated to the team-based approach. This model has helped the team dynamic significantly by taking a team-based approach rather than working in silos within the program. It has allowed work to be spread more evenly across the team and enhanced the ability to work from home or take time off with short notice. It has also allowed the RCs to focus on areas of research that play to their strengths. Some team members prefer to recruit or do data entry for studies, whereas others prefer to participate in patient-facing visits. Conclusion(s): Team dynamics is an essential consideration for the success of clinical research programs. During a time of isolation and uncertainty, teams can overcome hurdles and become stronger by developing a shared vision and shared responsibilities across several studies. The team model has allowed individuals to work across teams using their strengths and talents.Copyright © 2022, European Cystic Fibrosis Society. All rights reserved

Stem Cells Transl Med ; 11(Suppl 1):S15, 2022.
Article in English | PMC | ID: covidwho-2008612


Introduction: Stroke is the fifth leading cause of death in the United States. Tissue plasminogen activator and mechanical thrombectomy are the only effective treatments, but many patients are ineligible for these treatments. Objective: The objective of this study was to determine whether an intravenous infusion of a non-HLA matched, unrelated donor umbilical cord blood (UCB) would improve functional outcomes. Methods: We conducted a phase II multicenter, randomized (2:1), placebo controlled, double-blinded trial of UCB in adults with acute ischemic stroke. Patients had to have adequate immune function. Cord blood units were selected from U.S. public cord banks based on blood type, race, and cell dose. Study product was infused 3-10 days post stroke. Participants were randomized within strata of National Institutes of Health Stroke Scale Score (NIHSS) (<12 vs ≥12), and study center. The primary endpoint was change in Modified Rankin Scale (mRS) (baseline minus day 90). The study was powered at 80% (odds ratio of 2). Key secondary outcomes included functional independence at day 90 (mRS <2), NIHSS, the Barthel Index, infusion reactions, and adverse events. Results: Seventy-nine participants were enrolled at 6 centers when the trial was closed early due to slow accrual related to COVID19;73 participants (47 randomized to UCB) were included in the safety and efficacy analyses. The median (range) of the change in mRS was 1 (–2, 3) in UCB and 1 (–1, 4) in placebo. A shift analysis based on the proportional odds model showed an odds ratio of 0.9 (95% CI: 0.4, 2.3) after adjustment for baseline mRS and randomization strata. No differences were observed on the key secondary outcomes. There were 17 mild infusion reactions (27.6% UCB;15.4% placebo). The distribution of serious and non-serious adverse events was similar between arms. Discussion: This study demonstrated the safety of infusing non-HLA matched UCB to adults with acute ischemic stroke. Feasibility and logistics were challenging. The primary efficacy endpoint did not demonstrate benefit in this underpowered sample size. In a secondary ad hoc analysis, a trend of improved functional outcomes at day 90 in recipients of UCB more than 5 days post stroke (Figure 1) could be explored in future trials.Figure 1.Cord blood versus placebo odds ratio by treatment latency (days).