Post-market modification of valves from AMBU bags (AMBU Inc, Columbia, MD, USA) may be more susceptible to failure during use compared with our use of commercial pressure regulators (produced under ISO standards). Our data do not cover the full range of clinical parameters. For our studies, inspiratory times were kept fixed, although in actual patients, inspiratory times may be intermittently adjusted. Furthermore, this scheme is not intended as a permanent solution for ventilating multiple patients, and should be used only with hospital administration approval and acknowledgement of the unique ethical considerations during a crisis (such as the COVID-19 pandemic). 11,12 Although the COVID-19 pandemic inspired our designs, it may have utility in other mass casualty scenarios such as natural disasters, terrorist attacks, and battlefield medicine. Future versions should aim to extend to more than two patients per ventilator. Declarations of interest GWF is a consultant for and on the speaker's bureau of Edwards LifeSciences. All other authors have no conflicts to declare. 4. Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirusinfected pneumonia in Wuhan, China. JAMA 2020; 323: 1061e9 5. Neyman G, Irvin CB. A single ventilator for multiple simulated patients to meet disaster surge.
<b><i>Introduction:</i></b> We examined the impact of the coronavirus disease 2019 (COVID-19) pandemic on our regional stroke thrombectomy service in the UK. <b><i>Methods:</i></b> This was a single-center health service evaluation. We began testing for COVID-19 on 3 March and introduced a modified “COVID Stroke Thrombectomy Pathway” on 18 March. We analyzed the clinical, procedural and outcome data for 61 consecutive stroke thrombectomy patients between 1 January and 30 April. We compared the data for January and February (“pre-COVID,” <i>n</i> = 33) versus March and April (“during COVID,” <i>n</i> = 28). <b><i>Results:</i></b> Patient demographics were similar between the 2 groups (mean age 71 ± 12.8 years, 39% female). During the COVID-19 pandemic, (a) total stroke admissions fell by 17% but the thrombectomy rate was maintained at 20% of ischemic strokes; (b) successful recanalization rate was maintained at 81%; (c) early neurological outcomes (neurological improvement following thrombectomy and inpatient mortality) were not significantly different; (d) use of general anesthesia fell significantly from 85 to 32% as intended; and (e) time intervals from onset to arrival, groin puncture, and recanalization were not significantly different, whereas internal delays for external referrals significantly improved for door-to-groin puncture (48 [interquartile range (IQR) 39–57] vs. 33 [IQR 27–44] minutes, <i>p</i> = 0.013) and door-to-recanalization (82.5 [IQR 61–110] vs. 60 [IQR 55–70] minutes, <i>p</i> = 0.018). <b><i>Conclusion:</i></b> The COVID-19 pandemic has had a negative impact on the stroke admission numbers but not stroke thrombectomy rate, successful recanalization rate, or early neurological outcome. Internal delays actually improved during the COVID-19 pandemic. Further studies should examine the effects of the COVID-19 pandemic on longer term outcome.
e18672 Background: Representation of key demographic characteristics in real-world settings and clinical trial environments is medically necessary to address evidentiary gaps and disparities in clinical outcomes among patients with advanced renal cell carcinoma (aRCC). We characterized age, race, and ethnicity in patients with aRCC in real-world evidence (RWE), corresponding randomized controlled trials (RCTs), and Surveillance, Epidemiology, and End Results (SEER) data during contemporaneous periods spanning 2017-2022. Methods: Demographic characteristics were assessed from one RWE chart review study, two RCTs (Checkmate 214 and Keynote 426), and a SEER cohort based on RCT/RWE eligibility criteria and compared across data sources using 2-sided chi-square or t-tests. Results: Age, race and ethnicity were collected for 4,821 patients (RWE: n = 635, 13.2%; RCT: Checkmate 214 n = 1,096 and Keynote 426 n = 861, 40.6% across both RCTs; SEER: n = 2,229, 46.2%). RCT participants were younger at metastatic diagnosis (60.9 vs 65.1 years) and at 1L therapy initiation (60.9 vs 65.7 years) compared to patients in RWE and SEER, respectively (both p < 0.0001). Black patients accounted for 17.2% in RWE, 1.6% in RCT, and 4.8% in SEER data, and Asian patients accounted for 6.3% in RWE, 11.8% in RCT, and 6.0% in SEER data. Hispanic representation was significantly higher in RWE studies than RCT studies, (15.0% vs 3.4%), P< .001. A significantly greater proportion of white patients was observed in RCTs than RWE (84.5% vs 71.7%) and greater representation of non-Hispanic white patients was observed in SEER vs RWE (67.5% vs 60.3%), P< .001 (Table 1). Conclusions: This study describes existing disparities in representation of age, race, and ethnicity among patients with aRCC in research. RCTs had lower representation of older, Black, and Hispanic patients with aRCC compared to SEER and RWE studies. Despite limitations including sparse data available among Hispanics in RCTs, RWE studies can provide greater visibility to traditionally medically underrepresented patients with aRCC. [Table: see text]
e18670 Background: Compared with patients in typical care settings, participants in randomized clinical trials (RCTs) tend to be younger and less diverse. We compared representation of age, race, and ethnicity at initiation of first-line (1L) therapy for metastatic breast cancer across real-world evidence (RWE), RCT, and Surveillance, Epidemiology, and End Results (SEER) registry data. Methods: RWE and SEER inclusion criteria were based on corresponding RCTs. We compared age, race, and ethnicity at initiation of 1L therapy among female patients with metastatic breast cancer across 2 RWE chart review studies (completed between 2019-2021), 4 RCTs with similar eligibility (reported between 2014–2021), and the latest SEER registry data (2017–2019) using t-tests and 2-sided chi-square tests. Results: We collected demographics of 57,479 patients (RWE: n = 860, 1.5%; RCT: n = 2,707, 4.7%; SEER: n = 53,912, 93.8%). Mean age at 1L therapy initiation was significantly higher in RWE than RCT studies (61.8 vs 56.0 years) and representation of Black patients was significantly higher in RWE than RCT studies (25.3% vs 2.9%), both P< .001. Mean age at metastatic diagnosis in SEER was 59.0 years; age at 1L initiation was not reported. SEER included 13.4% Non-Hispanic Black patients. Hispanic representation was 11.2% in RWE, not reported in RCT, and 15.9% in SEER studies (Table). Conclusions: Decisions about treatment choices among clinicians and payers are primarily driven by RCT results, yet they may not be representative of real-world populations. We found that RCTs had lower representation of older and Black patients than both SEER and RWE studies. Limitations included varying study periods, lack of Hispanic ethnicity reporting in RCTs, differential SEER participation by US region, and potential patient overlap. Well-conducted RWE studies may fill gaps left by RCTs for improving representation and generalizability to patients with metastatic breast cancer. [Table: see text]
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