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Background: Never before have clinical trials drawn as much public attention as those testing interventions for COVID-19. We aimed to describe the worldwide COVID-19 clinical research response and its evolution over the first 100 days of the pandemic. Methods: Descriptive analysis of planned, ongoing or completed trials by April 9, 2020 testing any intervention to treat or prevent COVID-19, systematically identified in trial registries, preprint servers, and literature databases. A survey was conducted of all trials to assess their recruitment status up to July 6, 2020. Results: Most of the 689 trials (overall target sample size 396,366) were small (median sample size 120; interquartile range [IQR] 60-300) but randomized (75.8%; n=522) and were often conducted in China (51.1%; n=352) or the USA (11%; n=76). 525 trials (76.2%) planned to include 155,571 hospitalized patients, and 25 (3.6%) planned to include 96,821 health-care workers. Treatments were evaluated in 607 trials (88.1%), frequently antivirals (n=144) or antimalarials (n=112); 78 trials (11.3%) focused on prevention, including 14 vaccine trials. No trial investigated social distancing. Interventions tested in 11 trials with >5,000 participants were also tested in 169 smaller trials (median sample size 273; IQR 90-700). Hydroxychloroquine alone was investigated in 110 trials. While 414 trials (60.0%) expected completion in 2020, only 35 trials (4.1%; 3,071 participants) were completed by July 6. Of 112 trials with detailed recruitment information, 55 had recruited <20% of the targeted sample; 27 between 20-50%; and 30 over 50% (median 14.8% [IQR 2.0-62.0%]). Conclusions: The size and speed of the COVID-19 clinical trials agenda is unprecedented. However, most trials were small investigating a small fraction of treatment options. The feasibility of this research agenda is questionable, and many trials may end in futility, wasting research resources. Much better coordination is needed to respond to global health threats.

Computed tomography (CT) diagnosis of empyema is challenging because current literature features multiple overlapping pleural findings. We aimed to identify informative findings for structured reporting. The screening according to inclusion criteria (P: Pleural empyema, I: CT C: culture/gram-stain/pathology/pus, O: Diagnostic accuracy measures), data extraction, and risk of bias assessment of studies published between 01-1980 and 10-2021 on Pubmed, Embase, and Web of Science (WOS) were performed independently by two reviewers. CT findings with pooled diagnostic odds ratios (DOR) with 95% confidence intervals, not including 1, were considered as informative. Summary estimates of diagnostic accuracy for CT findings were calculated by using a bivariate random-effects model and heterogeneity sources were evaluated. Ten studies with a total of 252 patients with and 846 without empyema were included. From 119 overlapping descriptors, five informative CT findings were identified: Pleural enhancement, thickening, loculation, fat thickening, and fat stranding with an AUC of 0.80 (hierarchical summary receiver operating characteristic, HSROC). Potential sources of heterogeneity were different thresholds, empyema prevalence, and study year.

Automated laboratory-based prediction models may support clinical decisions in Staphylococcus aureus bloodstream infections (BSIs), which carry a particularly high mortality. Small studies indicated that the laboratory-based Model for End-stage Liver Disease (MELD) score is a risk factor for mortality in critically ill patients with infections. For S. aureus BSIs, we therefore aimed to assess a potential association of the MELD score with mortality. In this single-centre observational study, all consecutive patients with a first episode of methicillin-susceptible S. aureus BSI occurring between 2001 and 2013 were eligible. Relevant patient data were retrieved from our prospective in-house BSI database. We assessed the association of the MELD score at day of BSI onset (range ± two days) with 30-day all-cause mortality using uni- and multivariable logistic regression analysis. 561 patients were included in the final analysis. The MELD score at BSI onset was associated with 30-day mortality in S. aureus BSIs (odds ratio per 1-point increase, 1.06; 95% confidence interval, 1.03‒1.09; P < 0.001). After adjustment for relevant patient and infection characteristics, an increased MELD score remained a predictor of 30-day mortality (adjusted odds ratio per 1-point increase, 1.05; 95% confidence interval, 1.01‒1.08; P = 0.005). In our study population, the MELD score at BSI onset was an independent predictor of mortality in S. aureus BSIs. We therefore suggest to prospectively validate the MELD score as part of clinical decision support systems in inpatients with suspected or confirmed BSI.

Background Accessibility to alcohol-based handrub (ABHR) dispenser is crucial to improve compliance to hand hygiene (HH), being offered as wall-mounted dispensers (ABHR-Ds), and/or pocket bottles. Nevertheless, information on the distribution and density of ABHR-Ds and their impact on HH have hardly been studied. Institutions such as the World Health Organisation or the Centers for Disease Control and Prevention do not provide guidance. The Robert-Koch-Institute (RKI) from Germany recommends an overall density of > 0.5 dispensers per patient bed. We aimed to investigate current conditions in hospitals to develop a standard on the minimal number of ABHR-D. Methods Between 07 and 09/2019, we applied a questionnaire to 178 hospitals participating in the Swissnoso National Surveillance Network to evaluate number and location of ABHR-Ds per bed in acute care hospitals, and compared the data with consumption and compliance with HH. Results 110 of the 178 (62%) hospitals provided data representing approximately 20,000 hospital beds. 83% hospitals provided information on both the total number of ABHR-Ds and patient beds, with a mean of 2.4 ABHR-Ds per bed (range, 0.4–22.1). While most hospitals (84%) had dispensers located at the room entrance, 47% reported also locations near or at the bed. Additionally, pocket-sized dispensers (100 mL) are available in 97% of hospitals. Conclusions Swiss hospitals provide 2.4 dispensers per bed, much more than governmental recommendation. The first study on the number of ABHR-Ds in hospitals may help to define a minimal standard for national and international recommendations

Background Preoperative skin antisepsis is an essential component of safe surgery. However, it is unclear how many antiseptic paints are needed to eliminate bacteria prior to incision. This study compared microbial skin counts after two and three antiseptic paints. Methods We conducted a prospective cohort study in non-emergency patients receiving a cardiac/abdominal surgery with standardized, preoperative skin antisepsis consisting of an alcoholic compound and either povidone iodine (PI) or chlorhexidine (CHX). We obtained three skin swabs from the participant’s thorax/abdomen using a sterile template with a 25 cm 2 window: After collection of the first swab prior to skin antisepsis, and once the second and third application of PI/CHX had dried out, we obtained a second and third swab, respectively. Our primary outcome was the reduction in microbial skin counts after two and three paints of PI/CHX. Results Among the 239 enrolled patients, there was no significant difference in the reduction of mean square root-transformed microbial skin counts with three versus two paints ( P  = 0.2). But distributions of colony forming units (CFUs) decreased from paint 2 to 3 in a predefined analysis ( P  = 0.002). There was strong evidence of an increased proportion of patients with zero CFU after paint 3 versus paint 2 ( P  = 0.003). We did not identify risk factors for insufficient reduction of microbial skin counts after two paints, defined as the detection of > 5 CFUs and/or ≥ 1 pathogens. Conclusions In non-emergency surgical patients, three antiseptic paints may be superior to two paints in reducing microbial skin colonization prior to surgery.

Background Transurethral resection of the prostate (TURP) and Greenlight laser vaporisation (GL) of the prostate are frequently performed urological procedures. For TURP, a single-dose antimicrobial prophylaxis (AP) is recommended to reduce postoperative urinary tract infections. So far, no international recommendations for AP have been established for GL. In a survey-based study in Switzerland, Germany and Austria, urologists reported routinely extending AP primarily for 3 days after both interventions. We therefore aim to determine whether single-dose AP with cotrimoxazole is non-inferior to 3-day AP with cotrimoxazole in patients undergoing TURP or GL of the prostate. Methods/design We will conduct an investigator-initiated, multicentre, randomised controlled trial. We plan to assess the non-inferiority of single-dose AP compared to 3-day AP. The primary outcome is the occurrence of clinically diagnosed symptomatic urinary tract infections which are treated with antimicrobial agents within 30 days after randomisation. The vast majority of collected outcomes will be assessed from routinely collected data. The sample size was estimated to be able to show the non-inferiority of single-dose AP compared to 3-day AP with at least 80% power (1 – β  = 0.8) at a significance level of α  = 5%, applying a 1:1 randomisation scheme. The non-inferiority margin was determined in order to preserve 70% of the effect of usual care on the primary outcome. For an assumed event rate of 9% in both treatment arms, this resulted in a non-inferiority margin of 4.4% (i.e. 13.4% to 9%). To prove non-inferiority, a total of 1574 patients should be recruited, in order to have 1416 evaluable patients. The study is supported by the Swiss National Science Foundation. Discussion For AP in TURP and GL, there is a large gap between usual clinical practice and evidence-based guidelines. If single-dose AP proves non-inferior to prolonged AP, our study findings may help to reduce the duration of AP in daily routine—potentially reducing the risk of emerging resistance and complications related to AP. Trial registration Clinicaltrials.gov, NCT03633643 . Registered 16 August 2018.

To exploit the full potential of big routine data in healthcare and to efficiently communicate and collaborate with information technology specialists and data analysts, healthcare epidemiologists should have some knowledge of large-scale analysis techniques, particularly about machine learning. This review focuses on the broad area of machine learning and its first applications in the emerging field of digital healthcare epidemiology.

Preliminary studies that analyzed surrogate markers have suggested that operating room (OR) door openings may be a risk factor for surgical site infection (SSI). We therefore aimed to estimate the effect of OR door openings on SSI risk in patients undergoing cardiac surgery. This prospective, observational study involved consecutive patients undergoing cardiac surgery in 2 prespecified ORs equipped with automatic door-counting devices from June 2016 to October 2017. Occurrence of an SSI within 30 days after cardiac surgery was our primary outcome measure. Respective outcome data were obtained from a national SSI surveillance cohort. We analyzed the relationship between mean OR door opening frequencies and SSI risk by use of uni- and multivariable Cox regression models. A total of 301 594 OR door openings were recorded during the study period, with 87 676 eligible door openings being logged between incision and skin closure. There were 688 patients included in the study, of whom 24 (3.5%) developed an SSI within 30 days after surgery. In uni- and multivariable analysis, an increased mean door opening frequency during cardiac surgery was associated with higher risk for consecutive SSI (adjusted hazard ratio per 5-unit increment, 1.49; 95% confidence interval, 1.11-2.00; P = .008). The observed effect was driven by internal OR door openings toward the clean instrument preparation room. Frequent door openings during cardiac surgery were independently associated with an increased risk for SSI. This finding warrants further study to establish a potentially causal relationship between OR door openings and the occurrence of SSI.