Project description:Biospecimen repositories play a vital role in enabling investigation of biologic mechanisms, identification of disease-related biomarkers, advances in diagnostic assays, recognition of microbial evolution, and characterization of new therapeutic targets for intervention. They rely on the complex integration of scientific need, regulatory oversight, quality control in collection, processing and tracking, and linkage to robust phenotype information. The COVID-19 pandemic amplified many of these considerations and illuminated new challenges, all while academic health centers were trying to adapt to unprecedented clinical demands and heightened research constraints not witnessed in over 100 years. The outbreak demanded rapid understanding of SARS-CoV-2 to develop diagnostics and therapeutics, prompting the immediate need for access to high quality, well-characterized COVID-19-associated biospecimens. We surveyed 60 Clinical and Translational Science Award (CTSA) hubs to better understand the strategies and barriers encountered in biobanking before and in response to the COVID-19 pandemic. Feedback revealed a major shift in biorepository model, specimen-acquisition and consent process from a combination of investigator-initiated and institutional protocols to an enterprise-serving strategy. CTSA hubs were well equipped to leverage established capacities and expertise to quickly respond to the scientific needs of this crisis through support of institutional approaches in biorepository management.
Project description:Real-world evidence (RWE) has garnered great interest to support registration of new therapies and label expansions by the United States Food and Drug Administration (FDA). Currently, practical insights on the design and analysis of regulatory-grade RWE are lacking. This study aimed to analyze attributes of real-world studies in FDA's decision-making and characteristics of full versus accelerated approvals through a systematic review of oncology product approvals. Oncology approvals from 2015 to 2020 were reviewed from FDA.gov. Applications were screened for inclusion of RWE, and variables related to regulatory designations of the application, pivotal clinical trial, and real-world studies were extracted. FDA feedback was reviewed to identify takeaways and best practices for adequate RWE. Among 133 original and 573 supplemental approvals for oncology, 11 and 2, respectively, included RWE; none predated 2017. All real-world studies were retrospective in nature; the most common data source was chart review, and the most common primary endpoint was overall response rate, as in the pivotal trial. The FDA critiqued the lack of the following: a prespecified study protocol, inclusion/exclusion criteria matching to the trial, comparability of endpoint definitions, methods to minimize confounding and address unmeasured confounding, and plans to handle missing data. All full (versus accelerated) approvals shared the following characteristics: high magnitude of efficacy in the pivotal trial; designations of orphan disease, breakthrough therapy, and priority review; and no advisory committee meeting held. This study found that findings from external control real-world studies complemented efficacy data from single-arm trials in successful oncology product approvals.
Project description:Clinicians are routinely subjected to intense and stressful working environments, and the current COVID-19 crisis increases their risk of psychological distress. Mindfulness has been shown to improve life satisfaction, resilience to stress, self-compassion, compassion and general well-being in healthcare workers. Based on their clinical experience, the authors present mindfulness moments for clinicians (MMFC), a selection of short, simple and accessible mindfulness practices to promote resilience and compassion among clinicians working in this pandemic. The practices can be used on the job and are accessible to both novice and experienced meditators. Most of these practices are extracted from evidence-based mindfulness programmes. Further research is indicated to assess the effectiveness of using MMFC to support clinicians in their work and to promote resilience.
Project description:According to the DESI 2022 digital economy and society ranking, Poland still ranks in one of the last position. Although, in digitising healthcare Poland has made significant progress over the last five years, some inequities in the usage of eHealth have been recognised. This has become an especially important topic after the COVID-19 pandemic. Suddenly, eHealth innovations were much needed to maintain the accessibility of healthcare. Thus, the aim of this study was to explore determinants of eHealth usage by Poles and identify existing potential barriers. Data was collected from the databases of Statistic Poland and statistical methods were employed in this research. The results showed that five variables such as Internet access, Internet use, Internet skills and average monthly disposable income per capita in PLN, along with the number of practicing physicians per capita were important determinants explaining eHealth usage by the analysed Poles between the age of 16–74. The findings showed to increase the usage of eHealth, health policy makers should ensure that Poles acquire and improve Internet skills. Based on results of the research an extended model of eHealth development in Poland, consisting of a central governmental institution and local facilities coordinating remote electronic services, collecting statistical data and providing educational campaigns, was proposed as well.
Project description:Emergencies, such as natural and manmade disasters, can present an opportunity or be a detriment to preventive healthcare. While stay-at-home orders which some states implemented to mitigate the impact of COVID-19 are known to reduce acute and routine care, little is known about missed preventive care. Dental care, unlike other forms of preventive care - such as pediatric vaccines and well-visits, is simpler to analyze as it is not practicable with telehealth. Using weekly foot traffic data by SafeGraph from January 2018 to June 2020, we examine the effect of stay-at-home orders on visits to dental offices, finding a 15.4% decline after March 2020 for states with stay-at-home orders. Surprisingly, we find that states which allowed dental care during the stay-at-home period experienced a further 7.4% decline in visits. Using Michigan Medicaid dental claims for children we find that the decline of 0.25 claims per month is driven primarily by fewer diagnostic and preventive care visits. Though some preventive visits were rescheduled, we estimate only 58% of visits missed in March and April 2020 were made up by the end of the year. These estimates quantify the short-term declines in preventive dental care, suggesting similar declines in other preventive care.
Project description:The COVID-19 pandemic led to a huge surge in deposits, although little is known about how this was distributed. This paper overcomes the lack of timely micro-data on households' liquidity by looking at supervisory data, introducing a new method to estimate the trend in liquidity distribution and the percentage of liquidity-poor households. We find that in 2020 there was a decrease both in the degree of deposit inequality among Italian households and in the share of liquidity-poor households, alongside government support measures that allowed some households at the bottom of the liquidity ladder to save out of their declining income. The increase in households' liquidity improved their ability to repay debts, and this could help spending patterns to rebound once confidence about the economic outlook is restored. Despite this, households with insufficient liquidity buffers still constitute a large share of population, making their debt repayment capacity dependent on the strength of the economic recovery.