Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

SummaryBackground Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatoryactions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19.Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospitalwith COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients wererandomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once perday by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatmentgroups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment andwere twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants andlocal study staff were not masked to the allocated treatment, but all others involved in the trial were masked to theoutcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treatpopulation. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) wereeligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomlyallocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall,561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days(rate ratio 0·97, 95% CI 0·87–1·07; p=0·50). No significant difference was seen in duration of hospital stay (median10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days(rate ratio 1·04, 95% CI 0·98–1·10; p=0·19). Among those not on invasive mechanical ventilation at baseline, nosignificant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilationor death (risk ratio 0·95, 95% CI 0·87–1·03; p=0·24).Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or otherprespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restrictedto patients in whom there is a clear antimicrobial indication

A controlled trial of electronic automated advisory vital signs monitoring in general hospital wards*

OBJECTIVES: Deteriorating ward patients are at increased risk. Electronic automated advisory vital signs monitors may help identify such patients and improve their outcomes. SETTING: A total of 349 beds, in 12 general wards in ten hospitals in the United States, Europe, and Australia. PATIENTS: Cohort of 18,305 patients. DESIGN: Before-and-after controlled trial. INTERVENTION: We deployed electronic automated advisory vital signs monitors to assist in the acquisition of vital signs and calculation of early warning scores. We assessed their effect on frequency, type, and treatment of rapid response team calls; survival to hospital discharge or to 90 days for rapid response team call patients; overall type and number of serious adverse events and length of hospital stay. MEASUREMENTS AND MAIN RESULTS: We studied 9,617 patients before (control) and 8,688 after (intervention) deployment of electronic automated advisory vital signs monitors. Among rapid response team call patients, intervention was associated with an increased proportion of calls secondary to abnormal respiratory vital signs (from 21% to 31%; difference [95% confidence interval] 9.9 [0.1-18.5]; p = .029). Survival immediately after rapid response team treatment and survival to hospital discharge or 90 days increased from 86% to 92% (difference [95% confidence interval] 6.3 [0.0-12.6]; p = .04). Intervention was also associated with a decrease in median length of hospital stay in all patients (unadjusted p < .0001; adjusted p = .09) and more so in U.S. patients (from 3.4 to 3.0 days; unadjusted p < .0001; adjusted ratio [95% confidence interval] 1.03 [1.00-1.06]; p = .026). The time required to complete and record a set of vital signs decreased from 4.1 ± 1.3 mins to 2.5 ± 0.5 mins (difference [95% confidence interval] 1.6 [1.4-1.8]; p < .0001). CONCLUSIONS: Deployment of electronic automated advisory vital signs monitors was associated with an improvement in the proportion of rapid response team-calls triggered by respiratory criteria, increased survival of patients receiving rapid response team calls, and decreased time required for vital signs measurement and recording (NCT01197326)

European Position Paper on Diagnostic Tools in Rhinology

The accurate diagnosis of rhinologic disease depends on the clinical history, examination findings and, in many cases, further investigations. There are a wide variety of diagnostic tests available, the choice of which depends upon the condition being assessed. This position paper is intended to provide an up-to-date comprehensive description of the diagnostic tools available to rhinologists, allergists, general otolaryngologists and other physicians with an interest in sinonasal disease. The literature has been reviewed and evidence-based recommendations are included. The relevant history and examination techniques are described, including endoscopic assessment of the nose. General and disease-specific quality of life instruments are an important tool in assessing the impact of rhinologic disease and the response to treatment. Relevant blood tests are discussed, as well as the various methods of allergy testing. Techniques for collecting microbiological and tissue samples are described, as well as the use of more specialised tests such as nasal nitric oxide and those evaluating ciliary structure and function. Imaging techniques and their indications are included. Chemosensory (smell and taste) testing is explained, and the available techniques for objective measurement of nasal airflow and patency are reviewed. Prompt and accurate diagnosis allows appropriate management to be initiated; an understanding of the currently available diagnostic tools is a vital part of the assessment of rhinologic disease

European Position Paper on Diagnostic Tools in Rhinology

The accurate diagnosis of rhinologic disease depends on the clinical history, examination findings and, in many cases, further investigations. There are a wide variety of diagnostic tests available, the choice of which depends upon the condition being assessed. This position paper is intended to provide an up-to-date comprehensive description of the diagnostic tools available to rhinologists, allergists, general otolaryngologists and other physicians with an interest in sinonasal disease. The literature has been reviewed and evidence-based recommendations are included. The relevant history and examination techniques are described, including endoscopic assessment of the nose. General and disease-specific quality of life instruments are an important tool in assessing the impact of rhinologic disease and the response to treatment. Relevant blood tests are discussed, as well as the various methods of allergy testing. Techniques for collecting microbiological and tissue samples are described, as well as the use of more specialised tests such as nasal nitric oxide and those evaluating ciliary structure and function. Imaging techniques and their indications are included. Chemosensory (smell and taste) testing is explained, and the available techniques for objective measurement of nasal airflow and patency are reviewed. Prompt and accurate diagnosis allows appropriate management to be initiated; an understanding of the currently available diagnostic tools is a vital part of the assessment of rhinologic disease.status: publishe

European position paper on the anatomical terminology of the internal nose and paranasal sinuses.

The advent of endoscopic sinus surgery led to a resurgence of interest in the detailed anatomy of the internal nose and paranasal sinuses. However, the official Terminologica Anatomica used by basic anatomists omits many of the structures of surgical importance. This led to numerous clinical anatomy papers and much discussion about the exact names and definitions for the structures of surgical relevance. This European Position Paper on the Anatomical Terminology of the Internal Nose and Paranasal Sinuses was conceived to re-evaluate the anatomical terms in common usage by endoscopic sinus surgeons and to compare this with the official Terminologica Anatomica. The text is a concise summary of all the structures encountered during routine endoscopic surgery in the nasal cavity, paranasal sinuses and at the interface with the orbit and skull base but does not provide a comprehensive text for advanced skull base surgery. It draws on a detailed review of the literature and provides a consensus where several options are available, defining the anatomical structure in simple terms and in English. It is recognised that this is an area of great variation and some indication of the frequency with which these variants are encountered is given in the text and table. All major anatomical points are illustrated, drawing on the expertise of the multi-national and multi-disciplinary contributors to this project