摘要
OBJECTIVE: To determine the probability of hospitalization for chronic degenerative disease in patients with COVID-19. MATERIALS AND METHODS: A retrospective cohort in patients with COVID-19, confirmed by RT-PCR. Two study groups were integrated, the exposed group made up of 3 subgroups, exclusively diabetes mellitus, exclusively arterial hypertension and exclusively obesity;the unexposed group was the one in which any chronic comorbidity was ruled out. Relative risk, multiple logistic regression and probability calculation of the event (hospitalization) were used. RESULT(S): The relative risk for hospitalization in diabetes was of 3.59 (95%CI;2.44-5.29), 3.20 (95%CI;2.10-4.87) in hypertension and 2.56 (95%CI;1.72-3.81) in obesity. The multiple regression equation was y = -1358 + 2388 (diabetes mellitus) + 2005 (systemic arterial hypertension) + 1458 (obesity). The probability of hospitalization when there was no chronic disease was of 20.6%, when there was a chronic disease the probability fluctuated between 52.5% and 73.5%, when there were two chronic diseases it varied from 89.1% to 95.4%, and when there were three diseases the probability of hospitalization was of 98.9%. CONCLUSION(S): In the context of the probability of hospitalization when there is a chronic degenerative disease or it is absent, the research shows the difference in these two scenarios, as revealed by the more than 70 percentage points identified in the extreme scenarios, a condition that, led to the clinical field, reaffirms the presence of chronic degenerative disease as a risk factor for hospitalization.Copyright © 2023 Comunicaciones Cientificas Mexicanas S.A. de C.V.. All rights reserved.
摘要
Development of medicines and vaccines for COVID-19 amplified the need for all US communities to participate in research. This recognition spurred interest in adopting inclusive and equitable research practices across industry and the clinical research ecosystem in general. Between 2018-2021, regulatory bodies, professional organizations, and working groups issued policy and/or recommendations outlining measures that support the conduct of inclusive and equitable clinical trials. We applied previously published multi-themed strategies, multi-stakeholder recommendations, and calls to action by surveying industry to document baseline practices towards equitable clinical trial representation in the US. Research Question: What strategies are industry leaders deploying to increase diversity in clinical trials? Methods: Using a 4-staged approach, we first identified 48 success factors sourced from 12 documents. This analysis included previously documented measures that are both inclusive of diverse populations as well as practices that facilitate insights from diverse communities. Second, a survey tool was developed that organized the individual success factors into 6 categories with one open-ended question on ecosystem changes;survey measures and 4 choices for each factor were “Actively implementing,” “Recommended to be implemented,” “No plans to implement,” and “No answer.” Third, the survey was administered between April 10-30, 2021, to 12 pharmaceutical companies all having a proven external commitment to health equity in oncology and all are represented on the 2021 1Q Biopharma top 25 by Market Cap report. Fourth, responses were anonymized and aggregated;results were provided to respondents. Results: The response rate was 67% (8/12). Responders indicated success factors across two major implementation categories as follows: “actively implemented” (51%);“recommended/planned for implementation” (44%). No responders added any additional success factors via free text. Being “actively implemented” was highest for the 3 categories “site selection” (78%), “general capabilities” (72%), “leadership” (53%). “Recommended/planned for implementation” was highest for the 3 categories “participant focused” (50%), “other factors” (50%), “racial and ethnic minority group data (REMG)” (48%). Conclusions: Pharmaceutical companies reported active implementation of success factors sourced from public documents across all categories. As an example, stakeholders have generally considered thoughtful site selection an important measure to enroll diverse representation in clinical trials as it may mitigate access barriers to participation. In the site selection category, the survey reported 7/8 companies were actively implementing three measures and 5/8 were actively implementing two measures. An approach and analysis should be considered for expansion to more biotech companies and include a process devised for annual fielding and transparently reporting results.
摘要
Background and Aims: We evaluated whether stroke severity, functional outcome and mortality are different in patients with ischemic stroke with or without COVID-19 infection. Methods: A prospective, observational, multicentre cohort study in Catalonia, Spain. Recruitment was consecutive from mid-March to mid-May 2020. Patients had had an acute ischemic stroke within 48 hours and a previous modified Rankin scale (mRS) score of 0 to 3. We collected demographic data, vascular risk factors, prior mRS score, NIHSS score, rate of reperfusion therapies, logistics and metrics. Primary end-point was functional outcome at 3 months. Favourable outcome was defined depending on the previous mRS score. Secondary outcome was mortality at 3 months. We performed mRS shift and multivariate analyses. Results: We evaluated 701 patients (mean age 72.3±13.3 years, 60.5% men), and 91 (13%) had COVID-19 infection. Median baseline NIHSS score was higher in COVID-19 patients compared to patients without COVID-19 [8 (3-18) vs 6 (2-14), p=0.049)]. Proportion of patients with a favourable functional outcome was 33.7% in the COVID-19 and 47% in the non-COVID-19 group. However, after a multivariate logistic regression analysis, COVID-19 infection did not increase the probability of unfavourable functional outcome. Mortality rate was 39.3% among COVID-19 patients and 16.1% in the non-COVID-19 group. In the multivariate logistic regression analysis, COVID-19 infection was a risk factor for mortality (HR 3.14 (95% CI, 2.10-4.71;p<0.001). Conclusions: Patients with ischemic stroke and COVID-19 infection have more severe strokes and higher mortality than stroke patients without COVID-19 infection. However, functional outcome is comparable in both groups.