ABSTRACT
Objectives Our primary study objective was to characterize hospitalization costs, charges, and length of hospital stay for coronavirus disease-2019 (COVID-19) patients treated with veno-venous (VV) extracorporeal membrane oxygenation (ECMO) in the United States during 2020. Secondarily, we explored differences in hospitalization costs, charges, and length of hospital stay based on hospital-level factors. Design Retrospective cohort study. Setting Multiple hospitals in the United States. Participants Adult patients with COVID-19 who were on VV ECMO in 2020 and had data in the national inpatient sample (NIS). Interventions None Measurements and Main Results Demographics and baseline comorbidities were recorded for patients. Primary study outcomes were hospitalization costs, charges, and length of hospital stay. Study outcomes were compared after stratification by hospital region, bed size, and for-profit status. The median hospitalization cost for the 3,315 patient weighted cohort was $200,300 [$99,623, $338,062]. Median hospitalization charges were $870,513 [$438,228, $1,553,157] and median length of hospital stay was 30 days [17, 46]. Survival to discharge was 54.4% for all patients in the cohort. Median hospitalization cost differed by region (P=0.01), bed size (P<0.001), and for-profit status (P=0.02). Median hospitalization charges also differed by region (P=0.04), bed size (P=0.002), and for-profit status (P<0.001). Length of hospital stay differed by region (P=0.03) and bed size (P<0.001), but not for-profit status (P=0.40). Hospitalization costs were lowest and charges were highest in private-for-profit hospitals. Large hospitals also had higher costs, charges, and length of hospital stay compared to small hospitals. Conclusions In a retrospective cohort study we found that hospitalization costs and charges for COVID-19 patients on VV ECMO were substantial, but similar to what has previously been reported for non-COVID-19 VV ECMO patients. We also observed significant variation in costs, charges, and length of hospital stay based on hospital-level factors.
ABSTRACT
Abstract-The COVID-19 pandemic has a global impact on the conduct of clinical trials of medical products. This article discusses implications of the COVID-19 pandemic on clinical research methodology aspects and provides points to consider to assess and mitigate the risk of seriously compromising the integrity and interpretability of clinical trials. The information in this article will support discussions that need to occur cross-functionally on an ongoing basis to "integrate all available knowledge from the ethical, the medical, and the methodological perspective into decision making." This article aims at facilitating: (i) risk assessments of the impact of the pandemic on trial integrity and interpretability; (ii) identification of the relevant data and information related to the impact of the pandemic on the trial that needs to be collected; (iii) short-term decision making impacting ongoing trial operations; (iv) ongoing monitoring of the trial conduct until completion, including the possible involvement of data monitoring committees, and adequately documenting all measures taken to secure trial integrity throughout and after the pandemic, and (v) proper analysis and interpretation of the eventual interim or final trial data.