Treatment with tocilizumab or corticosteroids for COVID-19 patients with hyperinflammatory state: a multicentre cohort study (SAM-COVID-19)

Objectives: The objective of this study was to estimate the association between tocilizumab or corticosteroids and the risk of intubation or death in patients with coronavirus disease 19 (COVID-19) with a hyperinflammatory state according to clinical and laboratory parameters. Methods: A cohort study was performed in 60 Spanish hospitals including 778 patients with COVID-19 and clinical and laboratory data indicative of a hyperinflammatory state. Treatment was mainly with tocilizumab, an intermediate-high dose of corticosteroids (IHDC), a pulse dose of corticosteroids (PDC), combination therapy, or no treatment. Primary outcome was intubation or death; follow-up was 21 days. Propensity score-adjusted estimations using Cox regression (logistic regression if needed) were calculated. Propensity scores were used as confounders, matching variables and for the inverse probability of treatment weights (IPTWs). Results: In all, 88, 117, 78 and 151 patients treated with tocilizumab, IHDC, PDC, and combination therapy, respectively, were compared with 344 untreated patients. The primary endpoint occurred in 10 (11.4%), 27 (23.1%), 12 (15.4%), 40 (25.6%) and 69 (21.1%), respectively. The IPTW-based hazard ratios (odds ratio for combination therapy) for the primary endpoint were 0.32 (95%CI 0.22-0.47; p < 0.001) for tocilizumab, 0.82 (0.71-1.30; p 0.82) for IHDC, 0.61 (0.43-0.86; p 0.006) for PDC, and 1.17 (0.86-1.58; p 0.30) for combination therapy. Other applications of the propensity score provided similar results, but were not significant for PDC. Tocilizumab was also associated with lower hazard of death alone in IPTW analysis (0.07; 0.02-0.17; p < 0.001). Conclusions: Tocilizumab might be useful in COVID-19 patients with a hyperinflammatory state and should be prioritized for randomized trials in this situatio

Percepción de la Utilidad del Expediente Clínico Electrónico en un Instituto Nacional de Salud

INTRODUCTION: The electronic clinical record is one of the most representative development examples of the biomedical informatics in Mexico. However the idea that prevails on the advantages it entails the implementation of this strategy in health facilities, after conducting a thorough review of the Ibero-American medical literature, not found evidence sufficient to recommend it as a good practice. MATERIAL AND METHODS: 890 electronic clinical record users were invited to participate in a public opinion survey Likert-type with a range of responses ranging from anything useful to very useful, they agreed to answer it 577 users among physicians, residents, nurses, administrative staff, social workers, therapists, psychologists and nutritionists/dietitians. The 23 version of the SPSS program was used for statistical analysis. RESULTS: Frequency, internal consistency (Cronbach´s alpha) and interobserver concordance (W Kendall) was calculated for each subset of users previous identification of reagents which shared the questionnaires of different disciplines and were subsequently grouped for each item, analyzing responses through non-parametric tests in order to find differences in the distribution of scores (Kruskal Wallis test), found that the questionnaires for physicians and nutrition staff had greater reliability for internal consistency (Cronbach = α. 943). Greater interobserver agreement took place between physicians (W Kendall =. 530). The questionnaire for nursing was the least consistent and concordant. CONCLUSION: Responses in general, provide evidence to recommend as good practice the use of the electronic clinical record during patients care since health professionals prefer this mode above the traditional clinical record; they believe that it contributes to improving the safety of patients to be more available information and approve its use is widespread in other national institutes of health.INTRODUCCIÓN: El Expediente Clínico Electrónico es uno de los ejemplos más representativos del desarrollo de la Informática Biomédica en México. No obstante la idea que prevalece sobre las ventajas que conlleva la implementación de esta estrategia en los establecimientos de salud, tras realizar una revisión exhaustiva de la literatura médica iberoamericana, no se encontró evidencia suficiente para recomendarla como punto de buena práctica. METODOLOGÍA: Se invitó a 890 usuarios del expediente clínico electrónico a participar en una encuesta de opinión tipo Likert con una gama de respuestas que va desde nada útil a muy útil, accedieron a responderla 577 usuarios entre los cuales se encontraban médicos adscritos y residentes, enfermeras, personal técnico administrativo, trabajadores sociales, terapeutas, psicólogos y nutriólogos/ dietistas. Para el análisis estadístico se utilizó la versión 23 del programa SPSS. RESULTADOS: La frecuencia, consistencia interna (alpha de Cronbach) y concordancia interobservador (W de Kendall) se calculó para cada subgrupo de usuarios previa identificación de los reactivos que compartían los cuestionarios de las diferentes disciplinas y posteriormente se agruparon para cada ítem, analizando las respuestas a través de pruebas no paramétricas con el fin de encontrar diferencias en la distribución de las puntuaciones (Prueba de Kruskal Wallis o de la mediana), se encontró que los cuestionarios para médicos adscritos y para el personal de nutrición tuvieron la mayor confiabilidad por consistencia interna (α de Cronbach= .943). La mayor concordancia interobservador sucedió entre los médicos adscritos (W de Kendall= .530). El cuestionario para enfermería fue el menos consistente y concordante. CONCLUSIÓN: Las respuestas en lo general, aportan evidencia para recomendar como punto de buena práctica el uso del expediente clínico electrónico durante el proceso de atención médica de los pacientes ya que los profesionales de la salud prefieren esta modalidad que el expediente clínico tradicional; consideran que contribuye a mejorar la seguridad de los pacientes al estar más disponible y consultable la información y aprueban que su uso se generalice en otros Institutos Nacionales de Salud