In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.

A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.

We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites.

The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies.

Obstructive sleep apnea (OSA) is a sleep disorder that is highly comorbid with psychiatric disorders, including depression and anxiety. Excessive daytime sleepiness (EDS) is common in psychiatric disorders and OSA. In participants with OSA, EDS can persist despite use of positive airway pressure (PAP) therapy. This analysis of real-world data aimed to describe EDS and its relationship with PAP use in participants with and without depression.

US residents (≥18 years of age, self-reported physician diagnosis of OSA [from 1/1/2015 to 3/31/2020]) completed a survey in Evidation Health’s Achievement app assessing subjective levels of sleepiness (Epworth Sleepiness Scale [ESS]) and self-reported PAP usage, categorized as nonuse (no PAP use), nonadherent (<4 h/night or <5 d/wk), intermediate (4-6 h/night, ≥5 d/wk), or highly adherent (≥6 h/night, ≥5 d/wk). ESS score >10 defined EDS. A linear model assessed relationships between PAP use and ESS score. P-values are uncontrolled for multiplicity (nominal).

In total, 2289 participants (EDS, n=972; no EDS, n=1317) completed the survey (50.3% female; 82.5% White; mean±standard deviation [SD] age, 44.8 ± 11.1 years). Anxiety and depression were the most common comorbidities and were more common in participants with EDS (49% and 49%, respectively) than those without EDS (41% and 37%, respectively). Overall, EDS was more common among participants with comorbid depression (49%) than those without (38%), even among highly adherent PAP users (46% vs 30%, respectively). In a linear model (PAP users only), an additional 1 h/night of PAP use was associated with lower ESS scores in the subgroup of participants without depression (n=928; estimate [SE], −0.42 [0.09]; P<0.05), but not in the subgroup with depression (n=661; estimate [SE], −0.15 [0.10]; P>0.05). In a sensitivity analysis that excluded participants using medications that cause sleepiness, PAP use was associated with lower ESS scores regardless of depression status; however, EDS remained more common in participants with comorbid depression (46%) than in those without (36%).

In this real-world population of participants with OSA, those with EDS were more likely to have comorbid anxiety or depression. EDS was more common in participants with comorbid depression than those without, even with highly adherent PAP use. PAP use was associated with lower ESS scores in participants without comorbid depression, but not in those with comorbid depression; the use of medications that cause sleepiness may contribute to but does not fully explain this phenomenon.

Axsome Therapeutics and Jazz Pharmaceuticals

Obstructive sleep apnea (OSA) is a highly prevalent sleep disorder that is often associated with numerous medical and psychiatric comorbidities. Patients with OSA experience a variety of symptoms that can be burdensome and affect their quality of life and satisfaction with care. Excessive daytime sleepiness (EDS) is a common symptom of OSA, and can persist despite primary airway therapy (e.g., positive airway pressure [PAP]). This analysis aimed to characterize common comorbidities, as well as symptoms present at OSA diagnosis and their burden in a real-world population of participants with OSA.

US residents (≥18 years of age, self-reported clinician diagnosis of OSA [from 1/1/2015 to 3/31/2020]) completed a survey in Evidation Health’s Achievement app that assessed self-reported sleepiness (Epworth Sleepiness Scale [ESS]), self-reported PAP usage, self-reported physician-diagnosed comorbidities, and information on their symptoms at time of OSA diagnosis. Self-reported PAP use was categorized as nonuse (no PAP use), nonadherent (<4 h/night or <5 d/wk), intermediate (4–6 h/night, ≥5 d/wk), or highly adherent (≥6 h/night, ≥5 d/wk). EDS was defined as ESS score >10. All data were summarized descriptively.

In total, 2289 participants completed the survey (50.3% female; 82.5% White; mean ± standard deviation [SD] age, 44.8 ± 11.1 years; mean ± SD age at OSA diagnosis, 40.7 ± 11.4 years; mean ± SD body mass index, 35.4 ± 8.7 kg/m2); 42.5% had EDS. Among the total population, 30.6% were PAP non-users, 6.7% were nonadherent, 9.8% were intermediate adherent, and 52.9% were highly adherent. Across the study population, the most common self-reported physician-diagnosed comorbidities were anxiety (44%) and depression (42%) followed by hypertension (39%), dyslipidemia (26%), and asthma (21%). Among the symptoms participants reported having had at the time of OSA diagnosis, the most common were EDS (79%), fatigue (79%), snoring (75%), and awakening with a dry mouth or sore throat (63%). Concentration/Memory problems (48%) and mood changes (46%) were also common. In the overall population, the symptoms present at the time of OSA diagnosis that were most likely to be highly burdensome were fatigue (53%), EDS (46%), snoring (35%), difficulty concentrating/memory issues (31%), and mood changes (25%).

These real-world survey data identify anxiety and depression as the most frequently reported comorbidities in a population of participants with OSA, each affecting over 40% of participants. In addition to classic OSA symptoms (e.g., EDS, fatigue, snoring, and awakening with dry mouth/sore throat), concentration/memory problems and mood changes were also common at the time of OSA diagnosis and were among the presenting symptoms most frequently reported as highly burdensome, along with fatigue, EDS, and snoring.

Axsome Therapeutics and Jazz Pharmaceuticals

As part of a quality improvement project beginning in October 2011, our centre introduced changes to reduce radiation exposure during paediatric cardiac catheterisations. This led to significant initial decreases in radiation to patients. Starting in April 2016, we sought to determine whether these initial reductions were sustained.

After a 30-day trial period, we implemented (1) weight-based reductions in preset frame rates for fluoroscopy and angiography, (2) increased use of collimators and safety shields, (3) utilisation of stored fluoroscopy and virtual magnification, and (4) hiring of a devoted radiation technician. We collected patient weight (kg), total fluoroscopy time (min), and procedure radiation dosage (cGy-cm2) for cardiac catheterisations between October, 2011 and September, 2019.

A total of 1889 procedures were evaluated (196 pre-intervention, 303 in the post-intervention time period, and 1400 in the long-term group). Fluoroscopy times (18.3 ± 13.6 pre; 19.8 ± 14.1 post; 17.11 ± 15.06 long-term, p = 0.782) were not significantly different between the three groups. Patient mean radiation dose per kilogram decreased significantly after the initial quality improvement intervention (39.7% reduction, p = 0.039) and was sustained over the long term (p = 0.043). Provider radiation exposure was also significantly decreased from the onset of this project through the long-term period (overall decrease of 73%, p < 0.01) despite several changes in the interventional cardiologists who made up the team over this time period.

Introduction of technical and clinical practice changes can result in a significant reduction in radiation exposure for patients and providers in a paediatric cardiac catheterisation laboratory. These reductions can be maintained over the long term.

To examine awareness and recall of healthy eating public education campaigns in five countries.

Data were cross-sectional and collected as part of the 2018 International Food Policy Study. Respondents were asked whether they had seen government healthy eating campaigns in the past year; if yes (awareness), they were asked to describe the campaign. Open-ended descriptions were coded to indicate recall of specific campaigns. Logistic models regressed awareness of healthy eating campaigns on participant country, age, sex, ethnicity, education, income adequacy and BMI. Analyses were also stratified by country.

Online surveys.

Participants were Nielsen panelists aged ≥18 years in Australia, Canada, Mexico, UK and the USA (n 22 463).

Odds of campaign awareness were higher in Mexico (50·9 %) than UK (18·2 %), Australia (17·9 %), the USA (13·0 %) and Canada (10·2 %) (P < 0·001). Awareness was also higher in UK and Australia v. Canada and the USA, and the USA v. Canada (P < 0·001). Overall, awareness was higher among males v. females and respondents with medium or high v. low education (P < 0·001 for all). Similar results were found in stratified models, although no sex difference was observed in Australia or UK (P > 0·05), and age was associated with campaign awareness in UK (P < 0·001). Common keywords in all countries included sugar/sugary drinks, fruits and vegetables, and physical activity. The top five campaigns recalled were Chécate, mídete, muévete (Mexico), PrevenIMSS (Mexico), Change4Life (UK), LiveLighter® (Australia), and Actívate, Vive Mejor (Mexico).

In Mexico, UK and Australia, comprehensive campaigns to promote healthy lifestyles appear to have achieved broad, population-level reach.