Oscillometric devices vs. arterial Doppler in measuring the ankle-arm index for the diagnosis of peripheral arterial disease. / Dispositivos oscilométricos frente a Doppler arterial en la medida del índice tobillo-brazo para el diagnóstico de la enfermedad arterial periférica.

INTRODUCTION: Peripheral arterial disease is a marker of vascular damage that is diagnosed by measuring the ankle-brachial index. The aim of this study was to determine the validity and agreement of the MESI ABPI-MD and Microlife WatchBP® office-ABI oscillometric devices with respect to the gold standard arterial Doppler. MATERIALS AND METHODS: Observational, cross-sectional, descriptive study of inpatients who underwent ABI measurement with the three devices. Values are considered normal between 1-1.4, indeterminate between 0.91-0.99 and pathological ≤0.9 and >1.4. RESULTS: A total of 187 patients (54.4% male) with a mean age of 66 years were included. The Doppler results were inferior to those of the oscillometric devices (median [IQR] 1.1 [0.2] vs. 1.2 [0.2], P<.05), with no significant differences between the automated devices (P=.29 for the right lower limb and P=.342 for the left lower limb). Both devices had high specificity (96.5-99.2%) and low sensitivity (29.5-45.4%). The correlation of the results was good-moderate for MESI and moderate for Microlife. The agreement between the two was acceptable-moderate. CONCLUSION: Automated oscillometric devices could be useful in asymptomatic patients as an alternative to arterial Doppler.

Efficacy of short-course colchicine treatment in hospitalized patients with moderate to severe COVID-19 pneumonia and hyperinflammation: a randomized clinical trial.

Some patients with COVID-19 pneumonia develop an associated cytokine storm syndrome that aggravates the pulmonary disease. These patients may benefit of anti-inflammatory treatment. The role of colchicine in hospitalized patients with COVID-19 pneumonia and established hyperinflammation remains unexplored. In a prospective, randomized controlled, observer-blinded endpoint, investigator-initiated trial, 240 hospitalized patients with COVID-19 pneumonia and established hyperinflammation were randomly allocated to receive oral colchicine or not. The primary efficacy outcome measure was a composite of non-invasive mechanical ventilation (CPAP or BiPAP), admission to the intensive care unit, invasive mechanical ventilation requirement or death. The composite primary outcome occurred in 19.3% of the total study population. The composite primary outcome was similar in the two arms (17% in colchicine group vs. 20.8% in the control group; p = 0.533) and the same applied to each of its individual components. Most patients received steroids (98%) and heparin (99%), with similar doses in both groups. In this trial, including adult patients with COVID-19 pneumonia and associated hyperinflammation, no clinical benefit was observed with short-course colchicine treatment beyond standard care regarding the combined outcome measurement of CPAP/BiPAP use, ICU admission, invasive mechanical ventilation or death (Funded by the Community of Madrid, EudraCT Number: 2020-001841-38; 26/04/2020).

Impact of the implementation of a Sepsis Code Program in medical patient management: a cohort study in an Internal Medicine ward / Impacto de la implementación del Programa Código Sepsis en una planta de hospitalización médica: estudio de una cohorte de pacientes de Medicina Interna

Introduction. Sepsis is the main cause of death in hospitals and the implementation of diagnosis and treatment bundles has shown to improve its evolution. However, there is alack of evidence about patients attended in conventional units.Methods. A 3-year retrospective cohort study was conducted. Patients hospitalized in Internal Medicine units withsepsis were included and assigned to two cohorts according toSepsis Code (SC) activation (group A) or not (B). Baseline andevolution variables were collected.Results. A total of 653 patients were included. In 296 cases SC was activated. Mean age was 81.43 years, median Charlson comorbidity index (CCI) was 2 and 63.25% showed somefunctional disability. More bundles were completed in group A:blood cultures 95.2% vs 72.5% (p < 0.001), extended spectrumantibiotics 59.1% vs 41.4% (p < 0.001), fluid resuscitation96.62% vs 80.95% (p < 0.001). Infection control at 72 hourswas quite higher in group A (81.42% vs 55.18%, odds ratio3.55 [2.48-5.09]). Antibiotic was optimized more frequently ingroup A (60.77% vs 47.03%, p 0.008). Mean in-hospital staywas 10.63 days (11.44 vs 8.53 days, p < 0.001). Complicationsduring hospitalization appeared in 51.76% of patients, especially in group B (45.95% vs 56.58%, odds ratio 1.53 [1.12-2.09]). Hospital readmissions were higher in group A (40% vs24.76%, p < 0.001). 28-day mortality was significantly lower ingroup A (20.95% vs 42.86%, odds ratio 0.33 [0.23-0.47]).Conclusions. Implementation of SC seems to be effectivein improving short-term outcomes in IM patients, althoughtherapy should be tailored in an individual basis (AU)

Introducción. La sepsis es la principal causa de muerte enlos hospitales y la implantación de códigos para su manejo hademostrado mejorar su evolución. Sin embargo, es escasa laevidencia relativa a los pacientes atendidos en unidades médicas convencionales.Métodos. Se realizó un estudio de cohortes retrospectivode 3 años. Se incluyeron pacientes con sepsis hospitalizados enunidades de Medicina Interna y se asignaron a dos cohortessegún la activación del Código Sepsis (CS) (grupo A) o no (B).Se recogieron variables basales y de evolución.Resultados. Se incluyeron 653 pacientes. En 296 casos seactivó el SC. La edad media fue de 81,43 años, la mediana delíndice de comorbilidad de Charlson (ICC) fue de 2 y el 63,25%presentaba alguna limitación funcional. Se realizaron más acciones diagnósticas y terapéuticas en el grupo A: hemocultivos95,2% vs 72,5% (p < 0,001), antibióticos de espectro extendido59,1% vs 41,4% (p < 0,001), reanimación con líquidos 96,62%vs 80,95% (p < 0,001). El control de la infección a las 72 horasfue superior en el grupo A (81,42% vs 55,18%, odds ratio 3,55[2,48-5,09]). La optimización de los antibióticos fue más frecuente en el grupo A (60,77% vs 47,03%, p 0,008). La estanciamedia en el hospital fue de 10,63 días (11,44 vs 8,53 días, p <0,001). Aparecieron complicaciones durante la hospitalizaciónen el 51,76% de los pacientes, especialmente en el grupo B(45,95% vs 56,58%, odds ratio 1,53 [1,12-2,09]). Los pacientesdel grupo A reingresaron más (40% vs 24,76%, p < 0,001). Lamortalidad a los 28 días fue significativamente menor en elgrupo A (20,95% frente a 42,86%, odds ratio 0,33 [0,23-0,47]). (AU)

Subcutaneous IL-6 Inhibitor Sarilumab vs. Standard Care in Hospitalized Patients With Moderate-To-Severe COVID-19: An Open Label Randomized Clinical Trial.

Background: The use of IL-6 blockers in COVID-19 hospitalized patients has been associated with a reduction in mortality compared to standard care. However, many uncertainties remain pertaining to optimal intervention time, administration schedule, and predictors of response. To date, data on the use of subcutaneous sarilumab is limited and no randomized trial results are available. Methods: Open label randomized controlled trial at a single center in Spain. We included adult patients admitted with microbiology documented COVID-19 infection, imaging confirmed pneumonia, fever and/or laboratory evidence of inflammatory phenotype, and no need for invasive ventilation. Participants were randomly assigned to receive sarilumab, a single 400 mg dose in two 200 mg subcutaneous injections, added to standard care or standard care, in a 2:1 proportion. Primary endpoints included 30-day mortality, mean change in clinical status at day 7 scored in a 7-category ordinal scale ranging from death (category 1) to discharge (category 7), and duration of hospitalization. The primary efficacy analysis was conducted on the intention-to-treat population. Results: A total of 30 patients underwent randomization: 20 to sarilumab and 10 to standard care. Most patients were male (20/30, 67%) with a median (interquartile range) age of 61.5 years (56-72). At day 30, 2/20 (10%) patients died in the sarilumab arm vs. none (0/10) in standard care (Log HR 15.11, SE 22.64; p = 0.54). At day 7, no significant differences were observed in the median change in clinical status (2 [0-3]) vs. 3 [0-3], p = 0.32). Median time to discharge (days) was similar (7 [6-11] vs. 6 [4-12]; HR 0.65, SE 0.26; p = 0.27). No significant differences were detected in the rate of progression to invasive and noninvasive mechanical ventilation. Conclusions and Relevance: Our pragmatic pilot study has failed to demonstrate the benefit of adding subcutaneous sarilumab to standard care for mortality by 30 days, functional status at day 7, or hospital stay. Findings herein do not exclude a potential effect of sarilumab in severe COVID-19 but adequately powered blinded randomized phase III trials are warranted to assess the impact of the subcutaneous route and a more selected target population. Trial Registration: www.ClinicalTrials.gov, Identifier: NCT04357808.

Effectiveness and safety of first-line antiretroviral regimens in clinical practice: a multicentre cohort study.

OBJECTIVES: We compared 48 week effectiveness and safety of first-line antiretroviral regimens. METHODS: We analysed HIV treatment-naive adults from the Cohort of the Spanish HIV/AIDS Research Network (CoRIS) starting the most commonly used antiretroviral regimens from 2014 to 2018. We used multivariable regression models to assess the impact of initial regimen on: (i) viral suppression (VS) (viral load <50 copies/mL); (ii) change in CD4 cell count; (iii) CD4/CD8 normalization (>0.4 and >1); (iv) CD4 percentage normalization (>29%); (v) multiple T-cell marker recovery (MTMR: CD4 > 500 cells/mm3 plus CD4 percentage >29% plus CD4/CD8 > 1); (vi) lipid, creatinine and transaminase changes; and (vii) discontinuations due to adverse events (AE). RESULTS: Among 3945 individuals analysed, the most frequently prescribed regimens were ABC/3TC/DTG (34.0%), TAF/FTC/EVG/CBT (17.2%), TDF/FTC + DTG (11.9%), TDF/FTC/EVG/CBT (11.7%), TDF/FTC/RPV (11.5%), TDF/FTC + bDRV (8.3%) and TDF/FTC + RAL (5.3%). At 48 weeks, 89.7% of individuals achieved VS with no significant differences by initial regimen. CD4 mean increase was 257.8 (249.3; 266.2) cells/mm3, and it was lower with TAF/FTC/EVG/CBT and TDF/FTC/RPV compared with ABC/3TC/DTG. CD4 percentage normalization was less likely with TAF/FTC/EVG/CBT, and MTMR was less likely with TAF/FTC/EVG/CBT and TDF/FTC + RAL. The proportion of discontinuations due to AE was higher with TDF/FTC + bDRV (9.7%), followed by TDF/FTC/EVG/CBT (9.5%) and TDF/FTC + DTG (7.9%). Compared with ABC/3TC/DTG, cholesterol and LDL mean increases were higher with TAF/FTC/EVG/CBT and lower with TDF/FTC + DTG, TDF/FTC/RPV and TDF/FTC + RAL. Higher mean increases in triglycerides were significantly associated with TAF/FTC/EVG/CBT. Regimens containing DTG showed higher creatinine increases. CONCLUSIONS: The significantly greater immunological response and safety of some combinations may be useful for making decisions when initiating treatment.