Tag: statistics

Database (Oxford). 2021 Oct 9;2021:baab060. doi: 10.1093/database/baab060.

ABSTRACT

Following the European Commission No. 1332/2008 regulation and the consequent necessity of a scientific evaluation of food enzymes (FEs) for their approval for sale on the European Union market, many FE dossiers have been submitted to the European Commission and various documents currently co-exist. In order to centralize all relevant information in one structured location that is easily accessible to support enforcement laboratories and the competent authorities, we developed a web application, called Food Enzyme Database (FEDA). FEDA allows searching and collection of information originating from many different sources in one centralized portal. Queries can be performed using key information types, which include information on the producing company, production source (strain type, genetically modified microorganism status), type of enzyme protein and evaluation status with employed evaluation criteria. The database contains all current publicly available information. Centralizing all information coupled with intuitive searching functionality also allows the generation of general statistics regarding the current market situation. FEDA is open access and is freely available at the following location: https://feda.sciensano.be. Database URL : https://feda.sciensano.be.

PMID:34626475 | DOI:10.1093/database/baab060

Infect Dis Ther. 2021 Oct 9. doi: 10.1007/s40121-021-00537-0. Online ahead of print.

ABSTRACT

INTRODUCTION: Healthcare-associated (HCA) infections represent a growing public health problem. The aim of this study was to compare community-onset healthcare associated (CO-HCA) bacteremic urinary tract infections (BUTI) and hospital-acquired (HA)-BUTI with special focus on multidrug resistances (MDR) and outcomes.

METHODS: ITUBRAS-project is a prospective multicenter cohort study of patients with HCA-BUTI. All consecutive hospitalized adult patients with CO-HCA-BUTI or HA-BUTI episode were included in the study. Exclusion criteria were: patients < 18 years old, non-hospitalized patients, bacteremia from another source or primary bacteremia, non-healthcare-related infections and infections caused by unusual pathogens of the urinary tract. The main outcome variable was 30-day all-cause mortality with day 1 as the first day of positive blood culture. Logistic regression was used to analyze factors associated with clinical cure at hospital discharge and with receiving inappropriate initial antibiotic treatment. Cox regression was used to evaluate 30-day all-cause mortality.

RESULTS: Four hundred forty-three episodes were included, 223 CO-HCA-BUTI. Patients with CO-HCA-BUTI were older (p < 0.001) and had more underlying diseases (p = 0.029) than those with HA-BUTI. The severity of the acute illness (Pitt score) was also higher in CO-HCA-BUTI (p = 0.026). Overall, a very high rate of MDR profiles (271/443, 61.2%) was observed, with no statistical differences between groups. In multivariable analysis, inadequate empirical treatment was associated with MDR profile (aOR 3.35; 95% CI 1.77-6.35), Pseudomonas aeruginosa (aOR 2.86; 95% CI 1.27-6.44) and Charlson index (aOR 1.11; 95% CI 1.01-1.23). Mortality was not associated with the site of acquisition of the infection or the presence of MDR profile. However, in the logistic regression analyses patients with CO-HCA-BUTI (aOR 0.61; 95% CI 0.40-0.93) were less likely to present clinical cure.

CONCLUSION: The rate of MDR infections was worryingly high in our study. No differences in MDR rates were found between CO-HCA-BUTI and HA-BUTI, in the probability of receiving inappropriate empirical treatment or in 30-day mortality. However, CO-HCA-BUTIs were associated with worse clinical cure.

PMID:34626347 | DOI:10.1007/s40121-021-00537-0

Oncol Ther. 2021 Oct 9. doi: 10.1007/s40487-021-00173-1. Online ahead of print.

ABSTRACT

INTRODUCTION: Regorafenib is a multikinase inhibitor approved for the treatment of metastatic colorectal cancer (mCRC). Despite providing a statistically significant survival benefit, a substantial number of patients fail to respond to or continue with treatment, which has resulted in an unmet clinical need for a biomarker of regorafenib efficacy.

METHODS: The JACCRO CC-12 study was a prospective, multicenter, single-arm phase II trial designed to evaluate the usefulness of [¹⁸F]fluorodeoxyglucose positron emission tomography (FDG-PET) as an imaging biomarker of regorafenib in patients with mCRC that progressed after standard chemotherapies. FDG-PET and contrast-enhanced computed tomography (CT) were performed before and after treatment with regorafenib 160 mg once daily 3 weeks on/1 week off. The primary end point was the change in the maximum standardized uptake value in the lesion with the highest uptake at pre-treatment FDG-PET. The secondary end points included overall survival (OS), progression-free survival (PFS), the objective response rate (ORR), safety, and the correlation between FDG-PET and CT.

RESULTS: Twenty patients were enrolled from November 2014 to March 2016, 17 of whom were evaluated for metabolic and morphological changes. Metabolic response with FDG-PET was partial response (PR) in one case (5.9%), stable disease (SD) in four (23.5%), and progressive disease (PD) in 12 (70.6%). The metabolic response rate was 5.9%. On CT imaging, no complete response or PR was observed, and the ORR was 0%. Median PFS and OS were 1.7 and 9.8 months, respectively. The median PFS of patients who achieved PR or SD by FDG-PET was 3.7 months, whereas that of those assessed as PD was 1 month (p = 0.13). The median OS of patients who achieved PR or SD by FDG-PET was 13.0 months, whereas that of patients assessed as PD was 10.6 months (p = 0.43). Frequent adverse events were palmar-plantar erythrodysesthesia syndrome, hypertension, loss of appetite, and fatigue.

CONCLUSIONS: In this study, FDG-PET failed to demonstrate usefulness as an early imaging biomarker of regorafenib in patients with mCRC.

PMID:34626349 | DOI:10.1007/s40487-021-00173-1

Int J Clin Oncol. 2021 Oct 9. doi: 10.1007/s10147-021-02039-y. Online ahead of print.

ABSTRACT

BACKGROUND: More than 50% children with high-risk neuroblastoma (HR-NBL) experience disease progression, which we hypothesise is due to non-response of primary tumour to treatment. Current imaging techniques are unable to characterise response in primary tumour (necrotic versus viable tissue) at diagnosis or follow-up.

OBJECTIVES: Compare clinico-histological characteristics between primary ¹²³ImIBG-avid tumours that became entirely ¹²³ImIBG-non-avid (responders) after induction chemotherapy (IC) versus primary ¹²³ImIBG-avid tumour that remained ¹²³ImIBG-avid (non-responders).

METHODS: Retrospective review of clinico-radiological data of children diagnosed with ¹²³ImIBG-avid HR-NBL at our centre (2005-2016). Patients received Rapid COJEC IC and two additional courses of TVD if metastatic response was inadequate. Primary tumour ¹²³ImIBG response was assessed qualitatively as positive, negative or intermediate at diagnosis and after IC. Post-surgical histopathology slices were marked considering percentage of viable tissue.

RESULTS: Sixteen of 61 patients showed complete primary tumour ¹²³ImIBG response, 20 partial response, while 25 no response. There was no statistically significant difference between clinical demographics of complete responders and group of non- or partial responders. Mean percentage of viable tumour cells was higher in non-responders than in complete responders (44.6% vs 20.6%; p = 0.05). Five-year EFS was significantly higher in complete responders than non-responders (43 ± 15% vs 7 ± 6%; p < 0.005).

CONCLUSIONS: ¹²³ImIBG response in primary HR-NBL correlates with amount of necrotic tissue, skeletal metastatic ¹²³ImIBG response and outcome. An entirely ¹²³ImIBG non-avid tumour can still harbour viable tumour cells. Therefore, our findings do not support utility of primary tumour ¹²³ImIBG response in decision making regarding residual tumour surgery. Combining both, primary and metastatic ¹²³ImIBG response will improve interpretability of clinical trial results.

PMID:34626287 | DOI:10.1007/s10147-021-02039-y

Prev Sci. 2021 Oct 9. doi: 10.1007/s11121-021-01297-6. Online ahead of print.

ABSTRACT

Internationally, youth crime is a significant social problem. Violent youth crime has been rising over the past decade in the state of Victoria, Australia. Communities That Care (CTC) is a coalition training process designed to prevent youth crime. There has been limited evaluation outside the USA. Using a non-experimental design, this study employed official state crime statistics to evaluate the impact on crime as the five-phase CTC process was implemented between 2010 and 2019 across communities in Victoria. The standard five-phase CTC implementation cycle was supplemented with universal programs to reduce sales and supply of alcohol to underage youth (under 18 years). Growth models evaluated community trends in youth crime (all, person, property and deception and other), comparing communities that implemented CTC at phase 4 or greater with communities that had not implemented CTC. In accord with the hypotheses, the study found significant reductions in crimes associated with CTC over the period between 2010 and 2019. A 2% annual reduction in risk was observed for crimes against persons for all age groups (IRR = 0.98, 95% CI [0.96, 0.998]). A 5% annual reduction was observed for crimes of property and deception for adolescents aged between 10 and 17 years (IRR = 0.95, 95% CI [0.90, 0.99]). These findings support CTC as an intervention for preventing youth crime at a population level. Future studies should evaluate intervention mechanisms and economic benefits.

PMID:34626325 | DOI:10.1007/s11121-021-01297-6

Acta Neurochir (Wien). 2021 Oct 9. doi: 10.1007/s00701-021-05007-7. Online ahead of print.

ABSTRACT

BACKGROUND: External ventricular drainage (EVD) is one of the most common neurosurgical procedures in emergencies. This study aims to find out which factors influence the occurrence of EVD-related complications in a comparative investigation of metal needles and polyurethane catheters. This is the first clinical study comparing these two systems.

METHODS: Adult patients undergoing pre-coronal EVD placement via freehand burr hole trepanation were included in this prospective study. The exclusion criteria were the open EVD insertion and/or a pre-existing infectious disease of the central nervous system.

RESULTS: Two hundred consecutive patients were enrolled. Of these, 100 patients were treated by using metal EVD (group 1) and 100 patients with polyurethane catheters (group 2). The overall complication rate was 26% (misplacement 13.5%, hemorrhage 12.5%, infection 2.5%, and dislocation 1%) without statistically significant differences between both groups. Generalized brain edema and midline shift had a significant influence on misplacements (generalized brain edema: p = 0.0002, Cramer-V: 0.307, OR = 7.364, 95% CI: 2.691-20.148; all patients: p = 0.001, Cramer-V: 0.48, OR = 43.5, 95% CI: 4.327-437.295; group 1: p = 0.047, Cramer-V: 0.216, OR = 3.75, 95% CI: 1.064-13.221; group 2: midline shift: p = 0.038, Cramer-V: 0.195, OR = 3.626, 95% CI: 1.389-9.464) all patients: p = 0.053, Cramer-V: 0.231, OR = 5.533, 95% CI 1.131-27.081; group 1: p = 0.138, Cramer-V: 0.168, OR = 2.769, 95% CI: 0.813-9.429 group 2. Hemorrhages were associated with the use of oral anticoagulants or antiplatelet therapy (p = 0.002; Cramer-V: 0.220, OR = 3.798, 95% CI: 1.572-9.175) with a statistically similar influence in both groups.

CONCLUSION: Generalized brain edema has a significant influence on misplacements in both groups. Midline shift lost its significance when considering only the patients in group 2. Patients under oral anticoagulation and antiplatelet therapy have increased odds of EVD-associated hemorrhage. Metal needles and polyurethane catheters are equivalent in terms of patient safety when there are no midline shift and generalized brain edema.

PMID:34626273 | DOI:10.1007/s00701-021-05007-7

Esophagus. 2021 Oct 9. doi: 10.1007/s10388-021-00881-7. Online ahead of print.

ABSTRACT

BACKGROUND: Peroral endoscopic myotomy (POEM) is a standard treatment for achalasia. Several reports have described the efficacy and safety of POEM for elderly patients, but none has reported the efficacy and safety of POEM in a large number of elderly patients for > 3 years postoperatively. In this study, we examined the safety and outcome of POEM for 3 years postoperatively in 100 elderly patients.

METHODS: One hundred consecutive patients aged > 65 years who underwent POEM from September 2011 to March 2020 were included in this study. In analysis 1, we retrospectively investigated the safety and efficacy of POEM in all patients. In analysis 2, the efficacy and safety of POEM were statistically compared between two groups: the early elderly (65-74 years of age, 55 patients) and late elderly (≥ 75 years of age, 45 patients).

RESULTS: The technical success rate of POEM was 100%. In analysis 1, the 3-month, 1-year, 2-year, and 3-year efficacies of POEM (Eckardt score of ≤ 3) were 100% (92/92 cases), 100% (91/91 cases), 97.8% (88/90 cases), and 100% (92/92 cases), respectively. Procedure-related adverse events occurred in 11% of patients, but none was fatal. Two late elderly patients developed aspiration pneumonia due to delirium and underwent long-term hospitalization. In analysis 2, there were no significant differences in the efficacy and safety of POEM between the two age groups.

CONCLUSIONS: POEM is effective and safe for elderly patients. However, precautions are needed regarding the risk of adverse events associated with delirium when POEM is performed in elderly patients.

PMID:34626277 | DOI:10.1007/s10388-021-00881-7

World J Urol. 2021 Oct 9. doi: 10.1007/s00345-021-03850-y. Online ahead of print.

ABSTRACT

PURPOSE: To assess the efficacy and safety of intradetrusor botulinum toxin type A injections (IBTI) for idiopathic overactive bladder (iOAB) in non-neurological adults with an artificial urinary sphincter (AUS).

MATERIALS AND METHODS: We retrospectively selected, in the 11 French centers, members of a collaborative network (GENULF (Groupe d’étude de neuro-urologie de langue francaise)), the patients who had had an artificial urinary sphincter implantation and who had subsequently developed iOAB requiring IBTI. This study was approved by the French association of urology ethics committee (no 2018012).

RESULTS: Between 2006 and 2020, 33 patients were included from 5 French centers. Mean follow-up after the first IBTI was 47 months. The average age of the studied population was 68 years, with 70% of females. A complete resolution of symptoms at optimal IBTI dose was experienced by 21 (64%) patients. Seven (21%) patients had partial improvement. Five non-responder patients (15%) had no improvement at all. Maximum cystometric bladder capacity was 240 ml pre-IBTI and 335 ml post IBTI. Discontinuation free survival at 60 months was 50%. Two erosions occurred during the 6 months following an IBTI both in male patients with a perineal implantation. There were four AUS balloon perforations that occurred during the 6 months following an IBTI, all of them in female patients.

CONCLUSIONS: IBTI has a good efficacy for the treatment of iOAB in patients with an AUS. However, both patients and practicians must be aware of the risk of rare and usually mild complications.

PMID:34626226 | DOI:10.1007/s00345-021-03850-y

Maxillofac Plast Reconstr Surg. 2021 Oct 9;43(1):37. doi: 10.1186/s40902-021-00323-5.

ABSTRACT

OBJECTIVES: The purpose of this study was to compare differences in facial soft tissue thickness in three-dimensional (3D) images before and after orthognathic surgery in patients with skeletal Class III malocclusion and to obtain a better understanding of the relationship between hard and soft tissue changes after surgery.

MATERIALS AND METHOD: The present retrospective study included 31 patients with skeletal Class III malocclusion with mandibular chin deviation greater than 4 mm who had undergone cone-beam computed tomography before and 6 months after surgery. Seven bilateral points were established. Measurements were taken from software-generated multiplanar reconstructions. The predictor variables were timing (pre- and postoperatively) and side (deviated vs. nondedicated). A regression model and correlation analysis were conducted for statistical analysis.

RESULTS: The difference of bilateral facial soft tissue thickness was statistically significantly different between deviated and nondeviated sides (P < 0.05), with lower values observed on the deviated side. The soft tissue thickness has become nearly symmetric at local regions of the lower thirds of the face after orthognathic surgery. However, most measurements showed a negative correlation between changes in soft tissue thickness and changes in bone tissues.

CONCLUSIONS: Skeletal Class III malocclusion with facial asymmetry is accompanied by differences in soft tissue thickness when comparing Dev and N-Dev sides of the posterior region of the mandible, where soft tissues are thinner on the Dev side. Soft tissue thickness can compensate for or camouflage the underlying asymmetric mandible. In addition, the asymmetric soft tissue thickness on the lower third of the face can be partially improved by orthognathic surgery, but the amount of soft tissue thickness change is not consistent with that of hard tissue positional change.

PMID:34626245 | DOI:10.1186/s40902-021-00323-5

Eur J Public Health. 2021 Oct 9:ckab148. doi: 10.1093/eurpub/ckab148. Online ahead of print.

ABSTRACT

BACKGROUND: Although men who have sex with men (MSM) are considered at high risk for transmission of sexually transmitted infections, including HIV, there are few studies estimating the population size of MSM in Europe. We used network data from a survey of MSM in four cities to perform successive sampling-population size estimations (SS-PSE) to estimate MSM population sizes.

METHODS: Data were collected in 2013-14 in Bratislava, Bucharest, Verona and Vilnius using respondent-driven sampling (RDS). SS-PSE uses a Bayesian framework to approximate the RDS sampling structure via a successive sampling model and uses the selection order of the sample to provide information about the distribution of network sizes over the population members of MSM.

RESULTS: We estimate roughly 4600 MSM in Bratislava, 25 300 MSM in Bucharest, 7200 in Verona and 2900 in Vilnius. This represents 2.9% of the estimated adult male population in Bratislava, 2.3% in Bucharest, 2.7% in Verona and 1.5% in Vilnius. The number of MSM living with HIV would roughly be 200 in Bratislava, 4554 in Bucharest, 690 in Verona and 100 in Vilnius.

CONCLUSIONS: Benefits of this method are that no additional information from an RDS survey needs to be collected, that the sizes can be calculated ex post facto a survey and that there is a software programme that can run the SS-PSE models. However, this method relies on having reliable priors. Although many countries are estimating the sizes of their vulnerable populations, European countries have yet to incorporate similar and novel methods.

PMID:34626188 | DOI:10.1093/eurpub/ckab148