Incidence of urinary incontinence after hip fracture surgery and associated risk factors: a prospective study.

BACKGROUND: The contribution of the postoperative process to developing or worsening urinary incontinence (UI) after hip fracture surgery (HFS) remains unclear. We aimed to evaluate UI incidence and worsening among older patients undergoing HFS, and explore associated risk factors. METHODS: This prospective cohort study included patients ≥ 75 years admitted between October 2019 and October 2021 to the Traumatology Service of three hospitals in the Consorci Sanitari de Alt-Penedès i Garraf (Barcelona, Spain) with hip fracture requiring surgical treatment. UI was assessed using the first two questions of the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) at baseline and at days 30 (± 3 days) and 90 (± 3 days) after HFS. Surgery-related data and post-surgical complications were recorded. RESULTS: A total of 248 patients with a mean (SD) age of 85.8 (6.78) years were included; 77.8% were female and 154 (62.1%) had UI at baseline. After HFS, 3.24% experienced urinary tract infections (UTIs), 3.64%, acute urinary retention (AUR), 8.57%, constipation, and 53.9%, prolonged catheterization (> 24 h). Fifty-eight patients without baseline UI developed UI at 30 days, resulting in a UI incidence of 61.7% (95% CI 51.1-71.54) between days 0 and 30. Of the 248 patients, 146 (59.1%) experienced worsening of UI. AUR and UTIs were identified as risk factors for UI development and worsening after HFS, respectively. CONCLUSION: The incidence of UI in older patients after HFS is significant. Patient management protocols should consider AUR and UTIs to reduce or eliminate the incidence of UI in older patients undergoing HFS.

Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study.

BACKGROUND: The use of remote consultation modalities has exponentially grown in the past few years, particularly since the onset of the COVID-19 pandemic. Although a huge body of the literature has described the use of phone (tele) and video consultations, very few of the studies correspond to randomized controlled trials, and none of them has assessed the safety of these consultation modalities as the primary objective. The primary objective of this trial was to assess the safety of remote consultations (both video and teleconsultation) in the follow-up of patients in the hospital setting. METHODS: Multicenter, randomized controlled trial being conducted in four centers of an administrative healthcare area in Catalonia (North-East Spain). Participants will be screened from all individuals, irrespective of age and sex, who require follow-up in outpatient consultations of any of the departments involved in the study. Eligibility criteria have been established based on the local guidelines for screening patients for remote consultation. Participants will be randomly allocated into one of the two study arms: conventional face-to-face consultation (control) and remote consultation, either teleconsultation or video consultation (intervention). Routine follow-up visits will be scheduled at a frequency determined by the physician based on the diagnostic and therapy of the baseline disease (the one triggering enrollment). The primary outcome will be the number of adverse reactions and complications related to the baseline disease. Secondary outcomes will include non-scheduled visits and hospitalizations, as well as usability features of remote consultations. All data will either be recorded in an electronic clinical report form or retrieved from local electronic health records. Based on the complications and adverse reaction rates reported in the literature, we established a target sample size of 1068 participants per arm. Recruitment started in May 2022 and is expected to end in May 2024. DISCUSSION: The scarcity of precedents on the assessment of remote consultation modalities using randomized controlled designs challenges making design decisions, including recruitment, selection criteria, and outcome definition, which are discussed in the manuscript. TRIAL REGISTRATION: NCT05094180. The items of the WHO checklist for trial registration are available in Additional file 1. Registered on 24 November 2021.

Drug Repurposing for Cancers With Limited Survival: Protocol for a Retrospective Cohort Study.

BACKGROUND: Only 5% of the molecules tested in oncology phase 1 trials reach the market after an average of 7.5 years of waiting and at a cost of tens of millions of dollars. To reduce the cost and shorten the time of discovery of new treatments, "drug repurposing" (research with molecules already approved for another indication) and the use of secondary data (not collected for the purpose of research) have been proposed. Due to advances in informatics in clinical care, secondary data can, in some cases, be of equal quality to primary data generated through prospective studies. OBJECTIVE: The objective of this study is to identify drugs currently marketed for other indications that may have an effect on the prognosis of patients with cancer. METHODS: We plan to monitor a cohort of patients with high-lethality cancers treated in the public health system of Catalonia between 2006 and 2012, retrospectively, for survival for 5 years after diagnosis or until death. A control cohort, comprising people without cancer, will also be retrospectively monitored for 5 years. The following study variables will be extracted from different population databases: type of cancer (patients with cancer cohort), date and cause of death, pharmacological treatment, sex, age, and place of residence. During the first stage of statistical analysis of the patients with cancer cohort, the drugs consumed by the long-term survivors (alive at 5 years) will be compared with those consumed by nonsurvivors. In the second stage, the survival associated with the consumption of each relevant drug will be analyzed. For the analyses, groups will be matched for potentially confounding variables, and multivariate analyses will be performed to adjust for residual confounding variables if necessary. The control cohort will be used to verify whether the associations found are exclusive to patients with cancer or whether they also occur in patients without cancer. RESULTS: We anticipate discovering multiple significant associations between commonly used drugs and the survival outcomes of patients with cancer. We expect to publish the initial results in the first half of 2024. CONCLUSIONS: This retrospective study may identify several commonly used drugs as candidates for repurposing in the treatment of various cancers. All analyses are considered exploratory; therefore, the results will have to be confirmed in subsequent clinical trials. However, the results of this study may accelerate drug discovery in oncology. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48925.

Alterations in testicular positioning after normal descent: acquired cryptorchidism.

BACKGROUND: Acquired cryptorchidism or acquired undescended testis (UDT) is defined as the displacement of a testicle outside the scrotal sac after normal descent has been verified. There are still no clear guidelines on its management. OBJECTIVES: To analyze patients who underwent surgery for UDT in our setting to determine the prevalence of acquired cryptorchidism and to analyze the demographic and clinical characteristics of the population of children diagnosed with both acquired and congenital cryptorchidism, the age of presentation of both entities and the percentage of bilateral involvement. MATERIALS AND METHODS: This was a retrospective descriptive study using data from the clinical history of patients who underwent surgery for cryptorchidism between 2011 and 2022. The type of cryptorchidism, acquired or congenital, was recorded. Demographic and clinical data were collected. RESULTS: A total of 367 patients and 442 testicular units were included in the study (75 patients had bilateral involvement). In 54.75% (95% CI: 50.09%-59.40%) of the cases analyzed, cryptorchidism was acquired, and the mean age at the time of surgery was 7.39 years (SD 2.95). Twenty percent (95% CI: 16.29%-24.58%) of the patients presented with bilateral cryptorchidism and 64% (95% CI: 52.88%-75.11%) out of them were acquired on both sides. The diagnosis was metachronous in 42.6% (95% CI: 31.21%-54.12%) of bilateral cryptorchidism cases. DISCUSSION AND CONCLUSION: Acquired cryptorchidism accounts for more than half of cryptorchidism cases requiring surgery in our setting, with a clearly different age of presentation than that for congenital cryptorchidism. Therefore, it is necessary to monitor the presence of the testes in the scrotal sac until adolescence. It is also important to monitor patients with a history of cryptorchidism, not only for the management of the operated testicle but also for the early identification of patients who will develop metachronous contralateral cryptorchidism.

Machine learning for the development of diagnostic models of decompensated heart failure or exacerbation of chronic obstructive pulmonary disease.

Heart failure (HF) and chronic obstructive pulmonary disease (COPD) are two chronic diseases with the greatest adverse impact on the general population, and early detection of their decompensation is an important objective. However, very few diagnostic models have achieved adequate diagnostic performance. The aim of this trial was to develop diagnostic models of decompensated heart failure or COPD exacerbation with machine learning techniques based on physiological parameters. A total of 135 patients hospitalized for decompensated heart failure and/or COPD exacerbation were recruited. Each patient underwent three evaluations: one in the decompensated phase (during hospital admission) and two more consecutively in the compensated phase (at home, 30 days after discharge). In each evaluation, heart rate (HR) and oxygen saturation (Ox) were recorded continuously (with a pulse oximeter) during a period of walking for 6 min, followed by a recovery period of 4 min. To develop the diagnostic models, predictive characteristics related to HR and Ox were initially selected through classification algorithms. Potential predictors included age, sex and baseline disease (heart failure or COPD). Next, diagnostic classification models (compensated vs. decompensated phase) were developed through different machine learning techniques. The diagnostic performance of the developed models was evaluated according to sensitivity (S), specificity (E) and accuracy (A). Data from 22 patients with decompensated heart failure, 25 with COPD exacerbation and 13 with both decompensated pathologies were included in the analyses. Of the 96 characteristics of HR and Ox initially evaluated, 19 were selected. Age, sex and baseline disease did not provide greater discriminative power to the models. The techniques with S and E values above 80% were the logistic regression (S: 80.83%; E: 86.25%; A: 83.61%) and support vector machine (S: 81.67%; E: 85%; A: 82.78%) techniques. The diagnostic models developed achieved good diagnostic performance for decompensated HF or COPD exacerbation. To our knowledge, this study is the first to report diagnostic models of decompensation potentially applicable to both COPD and HF patients. However, these results are preliminary and warrant further investigation to be confirmed.

Characteristics and Outcomes by Ceiling of Care of Subjects Hospitalized with COVID-19 During Four Waves of the Pandemic in a Metropolitan Area: A Multicenter Cohort Study.

INTRODUCTION: The profiles of patients with COVID-19 have been widely studied, but little is known about differences in baseline characteristics and in outcomes between subjects with a ceiling of care assigned at hospital admission and subjects without a ceiling of care. The aim of this study is to compare, by ceiling of care, clinical features and outcomes of hospitalized subjects during four waves of COVID-19 in a metropolitan area in Catalonia. METHODS: Observational study conducted during the first (March-April 2020), second (October-November 2020), third (January-February 2021), and fourth wave (July-August 2021) of COVID-19 in five centers of Catalonia. All subjects were adults (> 18 years old) hospitalized with a proven SARS-CoV-2 infection and with therapeutic ceiling of care assessed by the attending physician at hospital admission. RESULTS: A total of 5813 subjects were analyzed. Subjects with a ceiling of care were mainly older (difference in median age of 20 years), with more comorbidities (Charlson index 3 points higher) and with fewer clinical signs at baseline than patients without a ceiling of care. Some features of their clinical profiles changed among waves. There were differences in treatments received during hospital admission across waves, but not between subjects with and without a ceiling of care. Subjects with a ceiling of care had a death incidence more than four times the death incidence of subjects a without a ceiling of care (risk ratio (RR) ranging from 3.5 in the first wave to almost 6 in the third and fourth). Incidence of severe pneumonia and complications for subjects with a ceiling of care was around 1.5 times the incidence in subjects without a ceiling of care. DISCUSSION: Analysis of hospitalized subjects with SARS-CoV-2 infection should be stratified according to therapeutic ceiling of care to avoid bias and outcome misestimation.

Mortality in Elderly Patients Taking Furosemide: Prospective Cohorts Study.

Objectives: Low blood pressure (BP) has been proposed as a risk factor of death in elderly patients. However, this association could be partially accounted for by the deleterious effects of BP-lowering drugs. We analyzed whether these drugs are associated to an increased risk of death in elderly patients taking multiple potential confounders into account. Design: This is a prospective cohort study. Setting and Participants. Probabilistic sample of 772 community-dwelling patients aged >65 years living in Spain, who were appointed for an initial clinical visit and followed up through telephone calls 4, 6, 9, 12, and 60 months afterwards. Methods: At baseline visit, BP was measured using standardized methods, and BP medications and risk factors of death in elderly patients (BMI, oxygen saturation, toxic habits, comorbidity, muscular strength, and functional and cognitive capacity) were collected. During the follow-up, the vital status of patients and the date of death were ascertained. Results: During a median 5-year follow-up, 226 all-cause deaths occurred among the 686 participants included in the analysis. In a Cox regression model that included all the BP drug classes, diuretics and nitrites were significantly associated with mortality (p < 0.005). Within diuretics, furosemide was found to be responsible for the association of the group. In multivariable Cox regression models adjusted for BP and the rest of the mortality risk factors, furosemide remained as the only BP drug that was independently associated with mortality (hazard ratio 2.34; p < 0.01). Conclusions: Furosemide was prospectively associated with increased mortality in older people. If confirmed, this drug should be taken into account by prescribers and considered a confounder in BP studies.

A New Paradigm in Parkinson's Disease Evaluation With Wearable Medical Devices: A Review of STAT-ONTM.

In the past decade, the use of wearable medical devices has been a great breakthrough in clinical practice, trials, and research. In the Parkinson's disease field, clinical evaluation is time limited, and healthcare professionals need to rely on retrospective data collected through patients' self-filled diaries and administered questionnaires. As this often leads to inaccurate evaluations, a more objective system for symptom monitoring in a patient's daily life is claimed. In this regard, the use of wearable medical devices is crucial. This study aims at presenting a review on STAT-ONTM, a wearable medical device Class IIa, which provides objective information on the distribution and severity of PD motor symptoms in home environments. The sensor analyzes inertial signals, with a set of validated machine learning algorithms running in real time. The device was developed for 12 years, and this review aims at gathering all the results achieved within this time frame. First, a compendium of the complete journey of STAT-ONTM since 2009 is presented, encompassing different studies and developments in funded European and Spanish national projects. Subsequently, the methodology of database construction and machine learning algorithms design and development is described. Finally, clinical validation and external studies of STAT-ONTM are presented.

Comparison of the Results of a Parkinson's Holter Monitor With Patient Diaries, in Real Conditions of Use: A Sub-analysis of the MoMoPa-EC Clinical Trial.

Background: For specialists in charge of Parkinson's disease (PD), one of the most time-consuming tasks of the consultations is the assessment of symptoms and motor fluctuations. This task is complex and is usually based on the information provided by the patients themselves, which in most cases is complex and biased. In recent times, different tools have appeared on the market that allow automatic ambulatory monitoring. The MoMoPa-EC clinical trial (NCT04176302) investigates the effect of one of these tools-Sense4Care's STAT-ON-can have on routine clinical practice. In this sub-analysis the agreement between the Hauser diaries and the STAT-ON sensor is analyzed. Methods: Eighty four patients from MoMoPa-EC cohort were included in this sub-analysis. The intraclass correlation coefficient was calculated between the patient diary entries and the sensor data. Results: The intraclass correlation coefficient of both methods was 0.57 (95% CI: 0.3-0.73) for the OFF time (%), 0.48 (95% CI: 0.17-0.68) for the time in ON (%), and 0.65 (95% CI%: 0.44-0.78) for the time with dyskinesias (%). Furthermore, the Spearman correlations with the UPDRS scale have been analyzed for different parameters of the two methods. The maximum correlation found was -0.63 (p < 0.001) between Mean Fluidity (one of the variables offered by the STAT-dON) and factor 1 of the UPDRS. Conclusion: This sub-analysis shows a moderate concordance between the two tools, it is clearly appreciated that the correlation between the different UPDRS indices is better with the STAT-ON than with the Hauser diary. Trial Registration: https://clinicaltrials.gov/show/NCT04176302 (NCT04176302).

Parotid irrigation: A promising option for juvenile recurrent parotitis.

OBJECTIVE: To study whether irrigating the parotid gland with saline solution through the parotid duct reduces the number of inflammatory episodes in patients with juvenile recurrent parotitis (JRP) over a 1-year period. METHODS: This was a retrospective cohort study using the electronic clinical history data of patients with JRP that were treated with parotid irrigation under general anaesthesia at the Paediatric Surgery units of Consorci Sanitari Alt Penedès-Garraf and Hospital Universitari Mútua de Terrassa. The number of inflammation episodes in the year before and the year after treatment was analysed. RESULTS: A total of 15 patients with JRP were evaluated, of whom 10 met the criteria for irrigation. Data from 9 patients were available. The procedure was performed without incident in all of the patients. There was no difficulty with probing the duct and no need for orifice dilation. No post-lavage complications were observed. Four patients had complete resolution of inflammation events (44.4%), and the remaining 5 patients had a decrease in the number of events. The Wilcoxon signed-rank test showed a statistically significant difference between the number of inflammation events before and after the intervention (p = 0.009). CONCLUSIONS: Parotid irrigation with saline solution could be a safe and effective first-line technique for the treatment of JRP. LEVEL-OF-EVIDENCE: IV.

COVID-19: Clinical Presentation and Prognostic Factors of Severe Disease and Mortality in the Oldest-Old Population: A Cohort Study.

INTRODUCTION: The oldest-old population (80 years or older) has the highest lethality from COVID-19. There is little information on the clinical presentation and specific prognostic factors for this group. This trial evaluated the clinical presentation and prognostic factors of severe disease and mortality in the oldest-old population. METHODS: This is an ambispective cohort study of oldest-old patients hospitalized for respiratory infection associated with COVID-19 and with a positive test by RT-PCR. The clinical presentation and the factors associated with severe disease and mortality were evaluated (logistic regression). All patients were followed up until discharge or death. RESULTS: A total of 103 patients (59.2% female) were included. The most frequent symptoms were fever (68.9%), dyspnoea (60.2%), and cough (39.8%), and 11.7% presented confusion. Fifty-nine patients (57.3%) presented severe disease, and 59 died, with 43 patients (41.7%) presenting both of these. In the multivariate analysis, female sex (odds ratio [OR] 0.31, 95% confidence interval [95% CI] 0.13-0.73, p 0.0074) and serum lactate dehydrogenase (LDH) (OR 2.55, 95% CI 1.21-5.37, p 0.0139) were associated with severe disease, and serum sodium was associated with mortality (OR 3.12, 95% CI 1.18-8.26, p 0.0222). No chronic disease or pharmacological treatment was associated with worse outcomes. CONCLUSIONS: The typical presenting symptoms of respiratory infection in COVID-19 are less frequent in the oldest-old population. Male sex and LDH level are associated with severe disease, and the serum sodium level is associated with mortality in this population.

Immunomodulatory therapy, risk factors and outcomes of hospital-acquired bloodstream infection in patients with severe COVID-19 pneumonia: a Spanish case-control matched multicentre study (BACTCOVID).

OBJECTIVES: The effect of the use of immunomodulatory drugs on the risk of developing hospital-acquired bloodstream infection (BSI) in patients with COVID-19 has not been specifically assessed. We aim to identify risk factors for, and outcomes of, BSI among hospitalized patients with severe COVID-19 pneumonia. METHODS: We performed a severity matched case-control study (1:1 ratio) nested in a large multicentre prospective cohort of hospitalized adults with COVID-19. Cases with BSI were identified from the cohort database. Controls were matched for age, sex and acute respiratory distress syndrome. A Cox proportional hazard ratio model was performed. RESULTS: Of 2005 patients, 100 (4.98%) presented 142 episodes of BSI, mainly caused by coagulase-negative staphylococci, Enterococcus faecalis and Pseudomonas aeruginosa. Polymicrobial infection accounted for 23 episodes. The median time from admission to the first episode of BSI was 15 days (IQR 9-20), and the most frequent source was catheter-related infection. The characteristics of patients with and without BSI were similar, including the use of tocilizumab, corticosteroids, and combinations. In the multivariate analysis, the use of these immunomodulatory drugs was not associated with an increased risk of BSI. A Cox proportional hazard ratio (HR) model showed that after adjusting for the time factor, BSI was associated with a higher in-hospital mortality risk (HR 2.59; 1.65-4.07; p < 0.001). DISCUSSION: Hospital-acquired BSI in patients with severe COVID-19 pneumonia was uncommon and the use of immunomodulatory drugs was not associated with its development. When adjusting for the time factor, BSI was associated with a higher mortality risk.

Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methods: study protocol.

INTRODUCTION: In recent years, multiple studies have aimed to develop and validate portable technological devices capable of monitoring the motor complications of Parkinson's disease patients (Parkinson's Holter). The effectiveness of these monitoring devices for improving clinical control is not known. METHODS AND ANALYSIS: This is a single-blind, cluster-randomised controlled clinical trial. Neurologists from Spanish health centres will be randomly assigned to one of three study arms (1:1:1): (a) therapeutic adjustment using information from a Parkinson's Holter that will be worn by their patients for 7 days, (b) therapeutic adjustment using information from a diary of motor fluctuations that will be completed by their patients for 7 days and (c) therapeutic adjustment using clinical information collected during consultation. It is expected that 162 consecutive patients will be included over a period of 6 months.The primary outcome is the efficiency of the Parkinson's Holter compared with traditional clinical practice in terms of Off time reduction with respect to the baseline (recorded through a diary of motor fluctuations, which will be completed by all patients). As secondary outcomes, changes in variables related to other motor complications (dyskinesia and freezing of gait), quality of life, autonomy in activities of daily living, adherence to the monitoring system and number of doctor-patient contacts will be analysed. The noninferiority of the Parkinson's Holter against the diary of motor fluctuations in terms of Off time reduction will be studied as the exploratory objective.Ethics and dissemination approval for this study has been obtained from the Hospital Universitari de Bellvitge Ethics Committee. The results of this study will inform the practical utility of the objective information provided by a Parkinson's Holter and, therefore, the convenience of adopting this technology in clinical practice and in future clinical trials. We expect public dissemination of the results in 2022. TRIAL REGISTRATION: NCT04176302; https://clinicaltrials.gov/show/NCT04176302.

Matched cohort study on the efficacy of tocilizumab in patients with COVID-19.

BACKGROUND: Tocilizumab has been proposed as a treatment for the new disease COVID-19, however, there is not enough scientific evidence to support this treatment. The objective of this study is to analyze whether the use of tocilizumab is associated with respiratory improvement and a shorter time to discharge in patients with COVID-19 and lung involvement. METHODS: Observational study on a cohort of 418 patients, admitted to three county hospitals in Catalonia (Spain). Patients admitted consecutively were included and followed until discharge or up to 30 days of admission. A sub-cohort of patients treated with tocilizumab and a sub-cohort of control patients were identified, matched by a large number of risk factors and clinical variables. Sub-cohorts were also matched by the number of other treatments for COVID-19 that patients received. Increment in SAFI (inspired oxygen fraction / saturation) 48 h after the start of treatment, and time to discharge, were the primary outcomes. Mortality, which was a secondary outcome, was analyzed in the total cohort, by using logistic regression models, adjusted by confounders. RESULTS: There were 96 patients treated with tocilizumab. Of them, 22 patients could be matched with an equivalent number of control patients. The increment in SAFI from baseline to 48 h of treatment, was not significantly different between groups (tocilizumab: -0.04; control: 0.09; p = 0.636). Also, no difference in time to discharge was found between the two sub-cohorts (logrank test: p = 0.472). The logistic regression models, did not show an effect of tocilizumab on mortality (OR 0.99; p = 0.990). CONCLUSIONS: We did not find a clinical benefit associated with the use tocilizumab, in terms of respiratory function at 48 h of treatment, or time to discharge.

Applicability and tolerability of electrical stimulation applied to the upper and lower leg skin surface for cueing applications in Parkinson's disease.

Due to possible sensory impairments in people with Parkinson's disease, several methodological aspects of electrical stimulation as a potential cueing method remain to be explored. This study aimed to investigate the applicability and tolerability of sensory and motor electrical stimulation in 10 people with Parkinson's disease. The study focused on assessing the electrical stimulation voltages and visual analogue scale discomfort scores at the electrical sensory, motor, discomfort, and pain thresholds. Results show that sensory electrical stimulation at the tibialis anterior, soleus, hamstrings, and quadriceps stimulation sites was applicable and tolerable for 6/10, 10/10, 9/10, and 10/10 participants, respectively. Furthermore, motor electrical stimulation at the tibialis anterior, soleus, hamstrings, and quadriceps stimulation sites were applicable and tolerable for 7/10, 7/10, 7/10, and 8/10 participants, respectively. Interestingly, the thresholds for the lower leg were higher than those of the upper leg. The data presented in this paper indicate that sensory and motor electrical stimulation is applicable and tolerable for cueing applications in people with Parkinson's disease. Sensory electrical stimulation was applicable and tolerable at the soleus and quadriceps sites. Motor electrical stimulation was not tolerable for two participants at any of the proposed stimulation sites. Therefore, future studies investigating motor electrical stimulation cueing, should apply it with caution in people with Parkinson's disease.

Asociación entre el tratamiento esteroideo a dosis alta, la función respiratoria y el tiempo hasta el alta en pacientes con COVID-19: Estudio de cohortes / Association between high-dose steroid therapy, respiratory function, and time to discharge in patients with COVID-19: Cohort study

OBJETIVO: Analizar si existe asociación entre el uso de glucocorticoides a dosis altas y la evolución de la SAFI (saturación/fracción inspirada de oxígeno) o el tiempo hasta el alta, en pacientes hospitalizados por COVID-19. MÉTODOS: Estudio observacional sobre una cohorte de 418 pacientes ingresados en 3 hospitales comarcales de Cataluña (España). Como resultados primarios se estudiaron la evolución de la SAFI en las primeras 48h de tratamiento y el tiempo hasta el alta. Los resultados se compararon entre pacientes tratados y no tratados con glucocorticoides (metilprednisolona 1-2mg/kg/día o dexametasona 20-40mg/día), mediante el análisis de subcohortes emparejadas por múltiples factores clínicos y pronósticos, así como mediante modelos multivariantes de Cox, ajustados por diversos factores pronósticos. El uso simultáneo de diferentes tratamientos para la COVID-19 fue tenido en cuenta, tanto en el emparejamiento de subcohortes como en la regresión de Cox. RESULTADOS: Hubo 187 pacientes con glucocorticoides; de ellos, 25 pacientes pudieron ser emparejados con un número equivalente de pacientes control. En las subcohortes emparejadas, no se apreció diferencia en el tiempo hasta el alta (log-rank: p = 0,291), ni en el cambio en la SAFI a las 48h desde la basal (glucocorticoides: −0,04; controles: +0,37; p = 0,095). Los modelos multivariantes mediante regresión de Cox mostraron un tiempo hasta el alta significativamente más largo en pacientes tratados con glucocorticoides (hazard ratio: 7,26; IC 95%: 3,30-15,95). CONCLUSIONES: No hemos encontrado mejoría en la función respiratoria o tiempo hasta el alta, asociado al uso de glucocorticoides a dosis altas

OBJECTIVE: To analyze whether there is an association between the use glucocorticoids at high doses, and the evolution of saturation/fraction of inspired oxygen (SAFI) or time to discharge, in patients hospitalized with COVID-19. METHODS: This was an observational study on a cohort of 418 patients admitted to three regional hospitals in Catalonia, Spain. As primary outcomes, we studied the evolution of SAFI in the first 48hours of treatment and the time to discharge. The results were compared between patients treated and untreated with glucocorticoids (methylprednisolone 1-2mg/kg/day o dexamethasone 20-40mg/day) through sub-cohort analyses matched for multiple clinical and prognostic factors, as well as through Cox multivariate models adjusted for prognostic factors. The simultaneous use of different treatments for COVID-19 was taken into account, both in sub-cohorts matching and in Cox regression. RESULTS: There were 187 patients treated with glucocorticoids; of these, 25 patients could be matched with an equivalent number of control patients. In the analysis of these matched sub-cohorts, no significant difference was observed in time to discharge (log-rank: p = 0.291) or the increment in SAFI at 48hours of treatment (glucocorticoides: −0.04; controls: +0.37; p = 0.095). Multivariate models using Cox regression showed a significantly longer time to discharge in patients treated with glucocorticoids (hazard ratio: 7.26; 95% IC: 3.30-15.95). CONCLUSIONS: We have not found improvement in respiratory function or time until discharge, associated with the use of glucocorticoids at high doses

[Association between high-dose steroid therapy, respiratory function, and time to discharge in patients with COVID-19: Cohort study]. / Asociación entre el tratamiento esteroideo a dosis alta, la función respiratoria y el tiempo hasta el alta en pacientes con COVID-19: Estudio de cohortes.

OBJECTIVE: To analyze whether there is an association between the use glucocorticoids at high doses, and the evolution of saturation/fraction of inspired oxygen (SAFI) or time to discharge, in patients hospitalized with COVID-19. METHODS: This was an observational study on a cohort of 418 patients admitted to three regional hospitals in Catalonia, Spain. As primary outcomes, we studied the evolution of SAFI in the first 48hours of treatment and the time to discharge. The results were compared between patients treated and untreated with glucocorticoids (methylprednisolone 1-2mg/kg/day o dexamethasone 20-40mg/day) through sub-cohort analyses matched for multiple clinical and prognostic factors, as well as through Cox multivariate models adjusted for prognostic factors. The simultaneous use of different treatments for COVID-19 was taken into account, both in sub-cohorts matching and in Cox regression. RESULTS: There were 187 patients treated with glucocorticoids; of these, 25 patients could be matched with an equivalent number of control patients. In the analysis of these matched sub-cohorts, no significant difference was observed in time to discharge (log-rank: p=0.291) or the increment in SAFI at 48hours of treatment (glucocorticoides: -0.04; controls: +0.37; p=0.095). Multivariate models using Cox regression showed a significantly longer time to discharge in patients treated with glucocorticoids (hazard ratio: 7.26; 95% IC: 3.30-15.95). CONCLUSIONS: We have not found improvement in respiratory function or time until discharge, associated with the use of glucocorticoids at high doses.

Association between high-dose steroid therapy, respiratory function, and time to discharge in patients with COVID-19: Cohort study.

OBJECTIVE: To analyze whether there is an association between the use glucocorticoids at high doses, and the evolution of saturation/fraction of inspired oxygen (SAFI) or time to discharge, in patients hospitalized with COVID-19. METHODS: This was an observational study on a cohort of 418 patients admitted to three regional hospitals in Catalonia, Spain. As primary outcomes, we studied the evolution of SAFI in the first 48 h of treatment and the time to discharge. The results were compared between patients treated and untreated with glucocorticoids (methylprednisolone 1 mg/kg/day o dexamethasone 20-40 mg/day) through sub-cohort analyses matched for multiple clinical and prognostic factors, as well as through Cox multivariate models adjusted for prognostic factors. The simultaneous use of different treatments for COVID-19 was taken into account, both in sub-cohorts matching and in COX regression. RESULTS: There were 187 patients treated with glucocorticoids; of these, 25 patients could be matched with an equivalent number of control patients. In the analysis of these matched sub-cohorts, no significant difference was observed in time to discharge (log-rank: p = 0.291) or the increment in SAFI at 48 h of treatment (glucocorticoides: -0.04; controls: +0.37; p = 0.095). Multivariate models using Cox regression showed a significantly longer time to discharge in patients treated with glucocorticoids (hazard ratio: 7.26; 95% IC: 3.30-15.95). CONCLUSIONS: We have not found improvement in respiratory function or time until discharge, associated with the use of glucocorticoids at high doses.

OBJETIVO: Analizar si existe asociación entre el uso de glucocorticoides a dosis altas y la evolución de la SAFI (saturación/fracción inspirada de oxígeno) o el tiempo hasta el alta, en pacientes hospitalizados por COVID-19. MÉTODOS: Estudio observacional sobre una cohorte de 418 pacientes ingresados en 3 hospitales comarcales de Cataluña (España). Como resultados primarios se estudiaron la evolución de la SAFI en las primeras 48 h de tratamiento y el tiempo hasta el alta. Los resultados se compararon entre pacientes tratados y no tratados con glucocorticoides (metilprednisolona 1-2 mg/kg/día o dexametasona 20-40 mg/día), mediante el análisis de subcohortes emparejadas por múltiples factores clínicos y pronósticos, así como mediante modelos multivariantes de Cox, ajustados por diversos factores pronósticos. El uso simultáneo de diferentes tratamientos para la COVID-19 fue tenido en cuenta, tanto en el emparejamiento de subcohortes como en la regresión de Cox. RESULTADOS: Hubo 187 pacientes con glucocorticoides; de ellos, 25 pacientes pudieron ser emparejados con un número equivalente de pacientes control. En las subcohortes emparejadas, no se apreció diferencia en el tiempo hasta el alta (log-rank: p = 0,291), ni en el cambio en la SAFI a las 48 h desde la basal (glucocorticoides: −0,04; controles: +0,37; p = 0,095). Los modelos multivariantes mediante regresión de Cox mostraron un tiempo hasta el alta significativamente más largo en pacientes tratados con glucocorticoides (hazard ratio: 7,26; IC 95%: 3,30-15,95). CONCLUSIONES: No hemos encontrado mejoría en la función respiratoria o tiempo hasta el alta, asociado al uso de glucocorticoides a dosis altas.