ABSTRACT
BACKGROUND: In May 2020, the ACCESS (The vACCine covid-19 monitoring readinESS) project was launched to prepare real-world monitoring of COVID-19 vaccines. Within this project, this study aimed to generate background incidence rates of 41 adverse events of special interest (AESI) to contextualize potential safety signals detected following administration of COVID-19 vaccines. METHODS: A dynamic cohort study was conducted using a distributed data network of 10 healthcare databases from 7 European countries (Italy, Spain, Denmark, The Netherlands, Germany, France and United Kingdom) over the period 2017 to 2020. A common protocol (EUPAS37273), common data model, and common analytics programs were applied for syntactic, semantic and analytical harmonization. Incidence rates (IR) for each AESI and each database were calculated by age and sex by dividing the number of incident cases by the total person-time at risk. Age-standardized rates were pooled using random effect models according to the provenance of the events. FINDINGS: A total number of 63,456,074 individuals were included in the study, contributing to 211.7 million person-years. A clear age pattern was observed for most AESIs, rates also varied by provenance of disease diagnosis (primary care, specialist care). Thrombosis with thrombocytopenia rates were extremely low ranging from 0.06 to 4.53/100,000 person-years for cerebral venous sinus thrombosis (CVST) with thrombocytopenia (TP) and mixed venous and arterial thrombosis with TP, respectively. INTERPRETATION: Given the nature of the AESIs and the setting (general practitioners or hospital-based databases or both), background rates from databases that show the highest level of completeness (primary care and specialist care) should be preferred, others can be used for sensitivity. The study was designed to ensure representativeness to the European population and generalizability of the background incidence rates. FUNDING: The project has received support from the European Medicines Agency under the Framework service contract nr EMA/2018/28/PE.
ABSTRACT
Background: The COVID-19 pandemic caused abrupt changes to children's lifestyles, such as changes in school, activities, and access to medical care. Children with attention deficit hyperactivity disorder (ADHD) may have experienced additional impacts due to these changes. The disruption of receiving school lunches and physical activity at school, and other and out-of- home activities could lead to changes in weight status for pediatric patients. The purpose of this study was to examine changes in BMI for pediatric patients with both overweight/obesity (OV/OB) and ADHD before and during the COVID-19 pandemic. Methods: De-Identified patient data from the only academic medical center in Mississippi was extracted from 2019-2021 using the Patient Cohort Explorer application. Participants included 100 patients between 6 and 16 years old with ADHD and a BMI at or above 25 who were randomly selected with documented outpatient encounters before March 2020 and after June 2020. Paired-sample t-tests were conducted to compare BMI before and during the COVID-19 pandemic. Results: For pediatric patients with both OV/OB and ADHD, results revealed significant differences in BMI during the COVID-19 pandemic [Before COVID-19 M = 30.42, SD = 4.67;during COVID-19 M = 32.20, SD = 4.85;t(99) = -8.084, p < .001]. Additional analyses revealed racial disparities related to change in BMI (t(91) = -2.22, p = 0.029), where patients identified as African American had a significantly higher change in BMI [BMI Change M(SD) = 2.28(1.97)] compared to patients who were Caucasian [BMI Change M(SD) = 1.26(2.43)]. Conclusions: Pediatric patients with both OV/OB and ADHD had an increase in BMI since the start of the COVID-19 pandemic. The disruptions of school and home routines and changes in lifestyle behaviors could potentially explain the increase in BMI. It is important for health-care providers to monitor changes in BMI during the pandemic, as well as for researchers to identify disparities related to observed health outcomes.
ABSTRACT
Introduction: Due to sheltering in place from the COVID-19 pandemic, our CF team required a means of managing clinic flow with the sudden change from in-person to telehealth appointments for our patients. Our team was in need of a complete and concise medium to communicate with one another during virtual clinic visits and provide necessary data to conduct the individual visits more efficiently. Prior to COVID-19, clinic visits occurred in-person and the team used a white dry-erase board to communicate clinic flow along with patient information helpful for the patient encounter. Due to shelter-in-place orders, most of the CF clinical staff are working remotely. Having a communication tool like a virtual white board allows for effective management of clinic flow. We want the patient clinic experience to be safe and meet the needs of our patients regardless of virtual or in-person. Methods: The process started with the CF clinic team recognizing a continued need for an effective communication tool, similar to the white board used in clinic. Using Google Sheets, a virtual white board was created based on the physical white board used in-person. Both the in-person and virtual white boards had a similar approach of listing patient names, appointment time, multidisciplinary roles, lab report dates, and imaging dates. After developing the virtual white board, it was reviewed by the team during pilot virtual clinics. Changes occurred over multiple plan-do-study-act cycles. The listed patient name became a hyperlink that connected directly to the virtual encounter with that specific patient. The listed dates for labs and imaging became hyperlinks to the actual lab and imaging reports. Other hyperlinks included a team encounter for discussion between staff, a shared patient folder, the patient discharge form, and the program spreadsheet for data tracking. All forms are accessible to staff for any changes and updates. Drop-down menus were added for the pulmonologists to notate exacerbation scores and for the mental health coordinator to notate the completion of mental health screens, assisting with Port CF Registry data. A post-survey was sent out via SurveyMonkey to our staff and patient family partners after the pilot virtual clinic for feedback. Results: The CF center has a total of 30 team members for both the pediatric and adult teams. Not all of the disciplines participated in virtual clinics due to COVID-19 changes for staff availability, such as physical therapy. The survey was completed by 19 (63%) of the 30 team members. Of the completed surveys, all staff feedback showed that the virtual white board was the most successful implementation in our telehealth clinics. The new virtual white board was well organized and staff liked “that everything was in one place.” Conclusion: The goal is to have effective communication between the team during clinic visits, improving the ability to provide individualized care. With the positive feedback response from the team, we have chosen to adopt this process as a part of our clinics moving forward for both virtual and in-person clinic visits.