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SNIP measures contextual citation impact by wighting citations based on the total of citations in a subject field. This was an observational study on a cohort of patients admitted to three regional hospitals in Catalonia, Spain. There were patients treated with glucocorticoids; of these, 25 patients could be matched with an equivalent of control patients.
Multivariate models using Cox regression showed a ificantly longer time to discharge in patients treated with glucocorticoids hazard ratio: 7. We have not found improvement in respiratory function or time until discharge, associated with the use of glucocorticoids at high doses..
In December , an epidemic outbreak associated with a new coronavirus SARS-CoV-2 with the clinical manifestations being mainly respiratory was reported in Wuhan China. Various pharmacological agents have been put forward as potential treatments, based on theoretical considerations, in vitro studies, or the of clinical trials conducted on other related viruses. However, current evidence has not confirmed the presence or absence of benefit of these treatments and even warns of the possible risks or adverse effects associated with their use.
Glucocorticoids have been considered as a potential treatment, based on the experience of their use in acute respiratory distress syndrome ARDS , 6,7 influenza infection 8 and infections by other similar coronaviruses such as severe acute respiratory syndrome SARS-CoV or the Middle East respiratory syndrome MERS-CoV , 9—13 even when clear benefit from their use has not been demonstrated in these pathologies. Observational studies with more robust methodology have used the Propensity Score as a matching technique.
However, many questions remain to be answered about the use of glucocorticoids in this disease, and while time passes until there are more from clinical trials, observational studies are a ificant source of evidence. This cohort was deed to be able to study the efficacy of the different drugs used in COVID, allowing the study by case matching.
Data were collected from all patients with a clinical condition compatible with COVID disease, from 12 March to 2 May , from the time of admission to discharge, or up to a maximum of 30 days of hospitalisation. The data collected included sociodemographic data, diseases, chronic treatment, symptoms of disease presentation, vital s and clinical evolution each day of hospitalisation, including the need for oxygen therapy, the fraction of inspired oxygen FiO 2 and the oxygen administration system nasal cannula, venturi oxygen mask, reservoir mask, invasive or non-invasive mechanical ventilation.
All treatments used during hospitalisation, and all analyses and chest x-rays were logged. Quality controls were established during the data collection process and the errors detected were corrected, with investigator-retraining as and when necessary. Glucocorticoid treatment was considered as an exposure variable.
For the purposes of this study, a patient was considered glucocorticoid exposed if he had received 3 doses of either of the drugs, and unexposed if he had not received any. A double strategy was used in the statistical analysis: 1 analysis of subcohorts paired by confounding factors and 2 analysis of unpaired subcohorts, adjusted by confounding factors. As part of the first strategy, a subcohort of glucocorticoid-treated patients and a matched subcohort of non-glucocorticoid-treated patients matching ratio were formed.
The patients were paired using the following prognostic markers, which were identified in bivariate analyses and multivariate models performed as an initial step: gender, age, obesity, heart failure, chronic renal failure, and sleep apnea-hypopnea syndrome SAHS. Follow-up for the study drug treated patients started the day they took the first dose of the drug.
Follow-up for each of the control patients started on the day during hospitalisation when the SF, vital s blood pressure, heart rate and temperature , radiological involvement and CRP were similar to those of the patient with whom they were paired. For the study drug treated patient, the baseline CRP was that obtained on the day follow-up started, or if that was not available, on the day prior to starting the treatment. Likewise, the baseline radiological involvement was that shown on the day treatment was started, or from another imaging result up to a maximum of 2 days prior to the start of treatment.
At no time was patient-pairing based on data obtained after the start of steroid treatment, nor at the beginning of the follow-up time in the case of the control patients. Missing data regarding radiological involvement were imputed as follows: the radiological involvement for the days between 2 identical x-rays was assumed to be the same as that of the two x-rays obtained e.
This maximum interpolation allowed, was six days of separation between X-rays. Missing data was not imputed for other variables. A 3-day margin was tolerated for the start of other treatments, between the study patient and their control patient. In independent analyses, the use of tocilizumab showed no association to the main of the study in our sample, so this drug was not included in matching the comparison subcohorts.
For pairing, a first step was performed using computing brute force algorithms, which identified all the possible controls in the database, for each of the patients who received the study treatment. The control could have an SF from 1. Once the potential controls were identified, pairing was then refined, choosing those most similar in terms of SF, blood pressure, heart rate and CRP, using the Propensity Score. The pairing success was verified by a comparison of means or percentages between groups. A different trend in patient progress improvement in one group and worsening in another was ruled out by checking that the difference between the SF on day 1 of the analysis, and the day prior to entering the analysis, was similar.
In the SF analyses, patients with palliative sedation were excluded, because SF is not related to disease severity in these patients. In the analyses of time to discharge, deceased patients were excluded. In the analysis of this subcohort, the total time of hospitalisation from day one of admission was included, and patients were considered as having been exposed to glucocorticoids if they had received them at any time during hospitalisation at least three doses.
Time to discharge excluding deceased patients and mortality were studied using Cox regression models, adjusted for the following covariates, which were selected both for their statistical association with the outcome and for their clinical relevance in the opinion of the investigators: sex, age, obesity, heart failure, chronic renal failure, SAHS, baseline saturation in the emergency room, CRP in the emergency room, and involved quadrants in the emergency X-ray. The radiological involvement was introduced in the model in a discrete way, with 5 values from 0 to 4 involved quadrants , age, CRP and saturation were entered in the linear model as numerical variables, while the rest of the factors were treated dichotomously presence vs.
For the statistical analysis, R software, version 3. Of the patients included in the analyses, In total, The characteristics of the paired subcohorts are shown in Table 1 and the characteristics of the unpaired subcohort are shown in Table 2.
Baseline characteristics of patients treated with glucocorticoids and their paired controls. Surviving patients were used for the calculations related to time to discharge. Maximum value of 4. Change in SF with respect to the day prior to the start of the follow-up period. of affected quadrants on an anteroposterior chest x-ray. Range: 0—4 0: no involvement; 4: involvement of upper and lower lobes of both lungs. of affected quadrants on an anteroposterior chest X-ray. Increase in respiratory function parameters, with respect to the first day of follow-up, in patients treated with glucocorticoids and paired controls.
In the paired cohorts, the mean time to discharge of the patients who did not die was In the unpaired cohort, this time was After adjustment of the model for the rest of the confounders was taken into consideration, the multivariate Cox regression models showed that glucocorticoid treatment was associated with longer hospitalisation hazard ratio 7. Kaplan-Meier comparison curves and log-rank test of the different subcohorts of patients studied.
There were 6 deaths 8. We consider this of events insufficient to draw conclusions. Our study has not shown a benefit associated with the use of high-dose glucocorticoids in terms of respiratory function SF or time to discharge. In fact, hospitalisation was longer in the group treated with glucocorticoids in the unpaired subcohort analyses.
Our coincide with those reported by Lu et al. Lu et al. In contrast, Chroboczek et al. Unfortunately, the publication does not report the type and regimen of the corticosteroid therapy. Along the same lines, a small study ly published in this journal by Callejas et al. We have not been able to analyse the mortality in our study, due to the low of events in our sample. However, it seems that the positive result of the RECOVERY trial is discordant with our which showed no benefit in the use of glucocorticoids in terms of lung function or time to discharge.
Aside from the difference in the primary endpoints, a of factors can explain this discrepancy. As the authors themselves point out in the publication of the of the RECOVERY trial, it is possible that the use of high doses of glucocorticoids is more harmful than beneficial, and therefore may be related to complications that could prolong hospitalisation, for example, as stated in the observational study by Lu et al. Our paired subcohorts only included one pair of intubated patients, with the rest of the patients with mild disease as can be seen in the average SF of both groups , so it may have been difficult to observe a benefit therein.
Given the observational nature of our study, the existence of residual confusion cannot be ruled out, mainly due to the tendency to administer glucocorticoids to patients at higher risk or with more severe disease. However, we feel that such confusion was unlikely or minor due to the exhaustive matching method used and the verification of the comparability of the groups. Furthermore, an imbalance between groups, with respect to the initially matched characteristics, can arise from the loss of patients after pairing, leading to the appearance of residual confusion.
In addition to its observational de, our study is limited by its small sample size, which creates statistical power problems, especially in the case of some of the most interesting outcomes, such as mortality, which could not be studied in this sample. Additionally, the use of secondary data, obtained from the medical history, might have lead to information biases.
However, given that the primary variables are quantitative parameters, which are influenced minimally by the observer or their expertise in obtaining measurements, and given that these parameters are routinely collected in clinical practice and hospital management, we consider the existence of a relevant bias of this type to be unlikely. In any case, the sample size and the observational nature of our study make it necessary to wait for the confirmation which can come via the of randomised clinical trials in which high doses of glucocorticoids have been used.
In conclusion, in this observational study we have not found evidence of a clinical benefit from the use of glucocorticoids at high doses in patients hospitalised for COVID The use of high-dose glucocorticoids could lengthen the time of hospitalisation in these patients.Sex search Sant Pere de Ribes
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