A 16-year Longitudinal Cohort Study of Incidence and Bacteriology of Necrotising Fasciitis in England

BACKGROUND: Necrotising fasciitis (NF) is a rapidly progressive, destructive soft tissue infection with high mortality. The primary aim of this study was to evaluate the incidence and mortality of NF amongst patients admitted to English National Health Service (NHS) hospitals. The secondary aims included the identification of risk factors for mortality and causative pathogens. METHODS: The Hospital Episodes Statistics database identified patients with NF admitted to English NHS Trusts from 1/1/2002 to 31/12/2017. Information on patient demographics, co-morbid conditions, microbiology specimens, surgical intervention and in-hospital mortality was collected. Uni- and multivariable analyses were performed to investigate factors related to in-hospital mortality. RESULTS: A total of 11,042 patients were diagnosed with NF. Age-standardised incidence rose from 9 per million in 2002 to 21 per million in 2017 (annual percentage change = 6.9%). Incidence increased with age and was higher in men. Age-standardised mortality rate remained at 16% over the study period, while in-hospital mortality declined. On multivariable analysis, the following factors were associated with increased risk of in-hospital mortality: emergency admission, female sex, history of congestive heart failure, peripheral vascular disease, chronic kidney disease and cancer. Admission year and diabetes, which was significantly prevalent at 27%, were not associated with increased risk of mortality. Gram-positive pathogens, particularly Staphylococci, decreased over the study period with a corresponding increase in Gram-negative pathogens, predominantly E. coli. CONCLUSION: The incidence of NF increased markedly from 2002 to 2017 although in-hospital mortality did not change. There was a gradual shift in the causative organisms from Gram-positive to Gram-negative

Evaluation of a multi-arm multi-stage Bayesian design for phase II drug selection trials – an example in hemato-oncology

Abstract Background Multi-Arm Multi-Stage designs aim at comparing several new treatments to a common reference, in order to select or drop any treatment arm to move forward when such evidence already exists based on interim analyses. We redesigned a Bayesian adaptive design initially proposed for dose-finding, focusing our interest in the comparison of multiple experimental drugs to a control on a binary criterion measure. Methods We redesigned a phase II clinical trial that randomly allocates patients across three (one control and two experimental) treatment arms to assess dropping decision rules. We were interested in dropping any arm due to futility, either based on historical control rate (first rule) or comparison across arms (second rule), and in stopping experimental arm due to its ability to reach a sufficient response rate (third rule), using the difference of response probabilities in Bayes binomial trials between the treated and control as a measure of treatment benefit. Simulations were then conducted to investigate the decision operating characteristics under a variety of plausible scenarios, as a function of the decision thresholds. Results Our findings suggest that one experimental treatment was less efficient than the control and could have been dropped from the trial based on a sample of approximately 20 instead of 40 patients. In the simulation study, stopping decisions were reached sooner for the first rule than for the second rule, with close mean estimates of response rates and small bias. According to the decision threshold, the mean sample size to detect the required 0.15 absolute benefit ranged from 63 to 70 (rule 3) with false negative rates of less than 2 % (rule 1) up to 6 % (rule 2). In contrast, detecting a 0.15 inferiority in response rates required a sample size ranging on average from 23 to 35 (rules 1 and 2, respectively) with a false positive rate ranging from 3.6 to 0.6 % (rule 3). Conclusion Adaptive trial design is a good way to improve clinical trials. It allows removing ineffective drugs and reducing the trial sample size, while maintaining unbiased estimates. Decision thresholds can be set according to predefined fixed error decision rates. Trial registration ClinicalTrials.gov Identifier: NCT01342692

Toxic Keratoconjunctivitis from Coral Reef

A 25-year-old woman presented with right eye pain, lid edema, conjunctival injection and chemosis, and mild corneal epitheliopathy after exposure to fluid content from an aquarium coral reef. Topical moxifloxacin and prednisolone were started 4 times daily, with full clinical resolution after 2 weeks. Toxin-mediated keratoconjunctivitis may occur after exposure to zoanthid coral reef, particularly in aquarium enthusiasts. Topical corticosteroids in tandem with topical antibiotics appear to be effective in mild disease. However, in severe cases that exhibit corneal infiltrates and stromal thinning, close observation is warranted in case of possible keratolysis. </jats:p

Toxic Keratoconjunctivitis from Coral Reef

The final, published version of this article is available at https://doi.org/10.1159/000517350A 25-year-old woman presented with right eye pain, lid edema, conjunctival injection and chemosis, and mild corneal epitheliopathy after exposure to fluid content from an aquarium coral reef. Topical moxifloxacin and prednisolone were started 4 times daily, with full clinical resolution after 2 weeks. Toxin-mediated keratoconjunctivitis may occur after exposure to zoanthid coral reef, particularly in aquarium enthusiasts. Topical corticosteroids in tandem with topical antibiotics appear to be effective in mild disease. However, in severe cases that exhibit corneal infiltrates and stromal thinning, close observation is warranted in case of possible keratolysis

Comparison of the Safety and Efficacy of a 3-Dimensional Heads-up Display vs a Standard Operating Microscope in Retinal Detachment Repair

Purpose: To evaluate the safety, efficacy, and efficiency of the Ngenuity 3-dimensional (3D) heads-up display (HUD) visualization system for primary rhegmatogenous retinal detachment (RRD) repair at a large academic medical center in the United States. Methods: This retrospective review comprised consecutive patients aged 18 years or older who had primary RRD repair (pars plana vitrectomy [PPV] alone or combined PPV and scleral buckle) performed by the same fellowship-trained vitreoretinal surgeon using the 3D visualization system and a traditional standard operating microscope (SOM) at Massachusetts Eye and Ear from June 2017 to December 2021. The minimum follow-up was 90 days. Results: The 3D HUD group comprised 50 eyes of 47 patients and the SOM group, 138 eyes of 136 patients. There were no between-group differences in single surgery anatomic success rates at 3 months (98% HUD vs 99% SOM; P = 1.00) or at the last follow-up (94% HUD vs 98% SOM; P = .40). The rate of postoperative proliferative vitreoretinopathy was similar between the 2 groups (3 months: 3% HUD vs 5% SOM, P = .94; last follow-up, 2% HUD vs 3% SOM, P = .93). There was no difference in the mean duration of surgery (57.4 ± 28.9 minutes HUD vs 59.4 ± 29.9 minutes SOM; P = .68). Conclusions: Anatomic and functional outcomes, in addition to surgical efficiency, of noncomplex primary RRD repair with a 3D HUD system were similar to those of surgery performed with an SOM. </jats:p

A 16-year Longitudinal Cohort Study of Incidence and Bacteriology of Necrotising Fasciitis in England

Abstract Background Necrotising fasciitis (NF) is a rapidly progressive, destructive soft tissue infection with high mortality. The primary aim of this study was to evaluate the incidence and mortality of NF amongst patients admitted to English National Health Service (NHS) hospitals. The secondary aims included the identification of risk factors for mortality and causative pathogens. Methods The Hospital Episodes Statistics database identified patients with NF admitted to English NHS Trusts from 1/1/2002 to 31/12/2017. Information on patient demographics, co-morbid conditions, microbiology specimens, surgical intervention and in-hospital mortality was collected. Uni- and multivariable analyses were performed to investigate factors related to in-hospital mortality. Results A total of 11,042 patients were diagnosed with NF. Age-standardised incidence rose from 9 per million in 2002 to 21 per million in 2017 (annual percentage change = 6.9%). Incidence increased with age and was higher in men. Age-standardised mortality rate remained at 16% over the study period, while in-hospital mortality declined. On multivariable analysis, the following factors were associated with increased risk of in-hospital mortality: emergency admission, female sex, history of congestive heart failure, peripheral vascular disease, chronic kidney disease and cancer. Admission year and diabetes, which was significantly prevalent at 27%, were not associated with increased risk of mortality. Gram-positive pathogens, particularly Staphylococci, decreased over the study period with a corresponding increase in Gram-negative pathogens, predominantly E. coli. Conclusion The incidence of NF increased markedly from 2002 to 2017 although in-hospital mortality did not change. There was a gradual shift in the causative organisms from Gram-positive to Gram-negative. </jats:sec

The impact of temperature changes on patients with acute coronary syndrome

Abstract Funding Acknowledgements Type of funding sources: None. Background There are few studies about changes in temperature as a risk factor instability of atheromatous plaque and Acute Coronary Syndrome (ACS). It is the first study in our country. Purpose To evaluate the impact of temperature on patients with Acute Coronary Syndrome. Methods This is a retrospective, observational, analytical study conducted in a single-center, in the period January-December 2018. We included patients with the diagnosis of ACS, hospitalized in CCU, who performed emergency coronary angiography. Data were collected retrospectively using patient records from archived files at the Statistics Center. Data on atmospheric parameters, measured at the weather monitoring station, were obtained from the National Meteorological Service database (average daily temperature in each district of the country). The number of inhabitants for the respective districts is taken from the National Institute of Statistics. Results The study included 1165 patients. A significant association was found between the number of ACS per day with temperature changes (r=-0.13, p&amp;lt;0.01). The highest number of ACS was in October 10.4%, whereas the lowest number was in January 10.6%, with a significant decreasing trend during May-June and the peak in October (p=0.04). Significant changes in the average monthly values of temperature were accompanied by a statistically significant increase in the number of cases as occurred in March-April and October-November. (p≤0.05) A statistically significant relationship was observed between seasonal changes in temperature with the number of cases with ACS. The autumn season prevails with 27.9% of the total cases, followed by the spring season with 25.6%, the summer season with 24.2%, and the winter season with 22.3%, (p = 0.04). Most cases in the cold period (November-March) occurred on days with statistically significant changes in Temperature. Conclusion The study notes an important relationship between seasonal, monthly, and daily changes of temperatures, in relation to the frequency of cases with Acute Coronary Syndrome. </jats:sec