Rapidly Establishing a Hospital-Based Convalescent Plasma Collection Center With the Alyx Apheresis Collection Device.

The effort to collect convalescent plasma from individuals who recovered from COVID-19 began in earnest during the spring of 2020. Either whole blood or apheresis donations were obtained, the latter yielding higher numbers of units per donor per collection and more frequent collections. The NorthShore University HealthSystem blood donor center purchased 2 Alyx (Fresenius Kabi) apheresis plasma collection devices and quickly implemented them in order to collect COVID-19 convalescent plasma. Apheresis-experienced and inexperienced phlebotomists operated the instruments. Donors were collected >14 days from symptom resolution and all donors were negative by SARS-CoV-2 nasopharyngeal swab. Both internal metrics of performance as well as a post donation survey were used to evaluate the feasibility implementing this collection program. During the first 100 days of the collection program, 650 plasma units were collected. In particular, during the first week of the program, 38 units were collected and distributed to hospitals under the emergency investigational new drug and expanded access program. Fifty-one donors (15%) were deferred due to vital signs out of range or donor screening questions. Thirty-one donors (10%) were deferred due to positive nasopharyngeal swab. Lower than target yield occurred in 16.6% of collections due to donor reactions or flow errors. Donors rated the overall program lower, but not the staff, when they reported symptoms related to collection. In conclusion, a hospital-based apheresis convalescent plasma collection program can be rapidly implemented. Donor reaction rates and vein infiltration rates should be carefully monitored for each phlebotomist.

Persistence of SARS-CoV-2 nasopharyngeal swab PCR positivity in COVID-19 convalescent plasma donors.

BACKGROUND: Nucleic acid persists after symptom resolution and infectivity for many viral infections via delayed clearance of nucleic acid fragments, non-infectious particles, or transmissible virus. For Coronavirus Disease 2019 (COVID-19), the relationship between nasopharyngeal (NP) swab positivity, the development of antibodies against COVID-19, and clinical history are unclear. STUDY DESIGN AND METHODS: Individuals who recovered from COVID-19 and volunteered to donate convalescent plasma (CP) were screened by NP swab PCR, responded to a questionnaire, and were tested for anti-COVID-19 antibodies. RESULTS: A proportion of 11.8% of individuals tested positive for SARS-CoV-2 by NP swab PCR greater than 14 days after the resolution of symptoms of active disease, including one donor who had asymptomatic disease and tested positive by NP swab 41 days after her initial diagnosis. Clinical history did not show a significant correlation with persistence of NP swab positivity. Also, NP swab positivity >14 days from symptom resolution did not correlate with anti-COVID-19 serology results. IgG anti-SARS-CoV-2 spike antibody strength correlated with hospitalization for COVID-19 using two different assays. Total anti-SARS-CoV-2 nucleocapsid antibody strength correlated with time from symptom resolution to sample collection and symptom duration. CONCLUSIONS: SARS-CoV-2 nucleic acid is detectable long after the resolution of symptoms in a significant percentage of previously diagnosed individuals, which is important to consider when interpreting PCR swab results. Persistence of PCR positivity does not correlate with antibody strength or symptoms of COVID-19. If anti-spike antibody is used to assess CP potency, individuals who suffered severe COVID-19 disease symptoms may represent better donors.

Tissue Adhesive Compared With Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial.

OBJECTIVE: To assess whether tissue adhesive after closure of Pfannenstiel incision for cesarean delivery lowers the risk of wound complications when compared with sterile strips. METHODS: In this multicenter randomized controlled trial, women undergoing cesarean delivery using Pfannenstiel skin incision were randomized to receive tissue adhesive (2-octyl cyanoacrylate) compared with sterile strips after closure of the skin incision. The primary outcome was a composite of wound complications (drainage, cellulitis, abscess, seroma, hematoma, or isolated wound separation) within 8 weeks of delivery. Secondary outcomes included operative time, readmission, office or emergency department visits, or antibiotic use for wound complications, and patient satisfaction with the cesarean scar. With 80% power and a 95% CI, a sample size of 432 per group (n=864) was required to detect a 50% reduction in the primary outcome. A planned interim analysis was performed after 500 patients delivered. A conditional power analysis revealed that the probability of showing a benefit with tissue adhesive was extremely low (6.2%), and the study was halted owing to futility. RESULTS: Between November 2016 and April 2018, 504 patients were randomized, and follow-up was achieved in 479 (95%). Wound complications occurred in 18 out of 238 patients (7.6%) in the tissue adhesive group and 19 out of 241 patients (7.9%) in the sterile strips group (relative risk 0.96; 95% CI 0.51-1.78). There were no significant differences with regard to types of wound complications, operative time, readmission, office or emergency department visits, antibiotics prescribed for wound complications, or patient scar assessment scores of pain, stiffness, and irregularity between the two groups. However, tissue adhesive performed slightly better in regard to itchiness of scar and overall scar satisfaction. CONCLUSION: Compared with sterile strips, tissue adhesive after closure of Pfannenstiel incision for cesarean delivery is unlikely to lower the risk of wound complications. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02838017.

An Exploration of Barriers Facing Physicians in Diagnosing and Treating Obesity.

PURPOSE: To determine whether primary care physicians can accurately assess body mass index (BMI) by visual inspection and to assess barriers related to the diagnosis and management of obesity. DESIGN: Prospective Survey Study. SETTING: Hospitals and Clinics. SUBJECTS: Primary care providers in the fields of Internal Medicine, Family Medicine and Obstetrics/Gynecology. MEASURES: Measures investigated included providers visual assessment of BMI, BMI knowledge, diagnosis and management of obese patients, and perceived barriers to treatment. ANALYSIS: Top and bottom quartiles and total scores were determined for responses regarding the reported management of obesity, reported comfort with care, and reported barriers to care and used as the cut point. Statistical analyses were utilized to examine relations and compare groups. RESULTS: 206 (74%) of the 280 eligible providers completed the survey. The accuracy of visual assessment of BMI was 52%. Physicians were more likely to underestimate BMI than overestimate (36% ± 4% vs 12% ± 6%, respectively, P < .001). Although 91% of providers report routinely calculating BMI, only 61% routinely discuss BMI. Providers feel comfortable providing exercise (72%) and dietary counseling (61%). However, fewer are comfortable prescribing medical (16.4%) and surgical options (36%). CONCLUSION: Visual assessment of BMI is not reliable. Primary care physicians in our study population do not consistently discuss obesity with their patients and many report insufficient knowledge with regard to treatment options. Further studies are needed to determine whether these results are valid for other physicians in various practice settings and to mid-level providers. In addition, research is needed that investigate how collaboration with providers outside the medical field could reduce the burden on physicians in treating patients with overweight or obesity.

The experience of depression, anxiety, and mania among perinatal women.

We assessed differential item functioning (DIF) based on computerized adaptive testing (CAT) to examine how perinatal mood disorders differ from adult psychiatric disorders. The CAT-Mental Health (CAT-MH) was administered to 1614 adult psychiatric outpatients and 419 perinatal women with IRB approval. We examined individual item-level differences using logistic regression and overall score differences by scoring the perinatal data using the original bifactor model calibration based on the psychiatric sample data and a new bifactor model calibration based on the perinatal data and computing their correlation. To examine convergent validity, we computed correlations of the CAT-MH with contemporaneously administered Edinburgh Postnatal Depression Scales (EPDS). The rate of major depression in the perinatal sample was 13 %. Rates of anxiety, mania, and suicide risk were 5, 6, and 0.4 %, respectively. One of 66 depression items, one of 69 anxiety items, and 15 of 53 mania items exhibited DIF (i.e., failure to discriminate between high and low levels of the disorder) in the perinatal sample based on the psychiatric sample calibration. Removal of these items resulted in correlations of the original and perinatal calibrations of r = 0.983 for depression, r = 0.986 for anxiety, and r = 0.932 for mania. The 91.3 % of cases were concordantly categorized as either "at-risk" or "low-risk" between the EPDS and the perinatal calibration of the CAT-MH. There was little evidence of DIF for depression and anxiety symptoms in perinatal women. This was not true for mania. Now calibrated for perinatal women, the CAT-MH can be evaluated for longitudinal symptom monitoring.