Category: Statistics

Environ Geochem Health. 2021 Apr 19. doi: 10.1007/s10653-021-00930-1. Online ahead of print.

ABSTRACT

An integrated approach using chemical and microbial indicators has been tested in two different sites of the Campania Plain (Southern Italy) with different land use covering and different hydrogeological features in order: (1) to define the water-rock interaction processes, (2) to differentiate sources of pollution in a detailed way (3) to evaluate the degree of water quality in the studied alluvial aquifer and (4) to identify the most worrying elements for human’s health. Groundwater have showed a HCO₃-Ca signature for both investigated sites, and a progressive enrichment in alkali ions has been highlighted moving from the boundary of the plain toward the coastal areas, due to groundwater interaction with volcanic rocks along the flow path. The application of the Factor Analysis allowed to identify different sources of pollution, which were attributed to (a) leaks in the sewer system for the Agro-Aversano Area and also the spreading of manure as fertilizers in agricultural activities for the Caiazzo Plain. Furthermore, it has been highlighted that the use of major elements, trace elements and microbiological indicators, allows to accurately differentiate contamination processes in progress. In fact, from the results of the Factor Analysis applied in the Agro-Aversano area, no significant statistically relationships between major elements and microbiological indicators of fecal contamination were highlighted, unlike the Caiazzo plain where statistically significant correlations have been found between major and trace elements and microbiological indicators. The use of a Groundwater Quality Index has shown general poor water quality for the majority of analyzed samples due to the high amount of Nitrate and Fecal indicators. The use of a Health Risk Assessment highlighted that Nitrate coupled with Fluoride represent the most important concern for human health compared to the all investigated parameters in both sites.

PMID:33871745 | DOI:10.1007/s10653-021-00930-1

Heart Vessels. 2021 Apr 19. doi: 10.1007/s00380-021-01842-x. Online ahead of print.

ABSTRACT

This study aimed to evaluate the early and mid-term outcomes of transcatheter aortic valve implantation (TAVI) and to assess valve durability. A total of 146 consecutive patients who underwent TAVI for severe aortic stenosis between October 2013 and August 2018 were retrospectively reviewed. All patients (mean age, 84 ± 6 years; age range 53-98 years; 42 males [28.7%]) had multiple comorbidities, with a mean logistic EuroSCORE of 30.9 ± 17.4%. Eighteen patients (12.3%) were aged 90 years or over. Five in-hospital deaths (3.4%) occurred, and 36 patients (24.7%) experienced major TAVI-related complications. With the transfemoral approach, 10 patients had major vascular complications, which mostly occurred with first-generation devices (n = 9) but less commonly with new-generation low-profile devices (P = 0.0078). During a follow-up period of 580 ± 450 (11-1738) days, 29 late deaths occurred. The survival rate was 86.0%, 78.0%, and 61.7% at 1, 2, and 3 years, respectively. Multivariate Cox hazard regression analysis revealed that more-than-moderate tricuspid regurgitation was the only independent risk factor for late deaths due to any cause (hazard ratio, 3.145; 95% confidence interval, 1.129-8.762; P = 0.0283). No statistically significant differences between post-TAVI before discharge from the hospital and at 4 years after TAVI were observed with respect to aortic valve area (1.76 ± 0.49 cm² vs. 1.64 ± 0.38 cm²; P = 0.1871) and mean pressure gradient (10.0 ± 4.6 mmHg vs. 7.9 ± 3.3 mmHg; P = 0.5032). TAVI was a feasible method with acceptable early and mid-term outcomes and valve durability for at least 4 years in poor-risk patients. Further close follow-up is essential to evaluate late outcomes and valve durability.

PMID:33871699 | DOI:10.1007/s00380-021-01842-x

J Perianesth Nurs. 2021 Apr 15:S1089-9472(20)30306-3. doi: 10.1016/j.jopan.2020.08.017. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of the quality improvement (QI) project was to improve patient safety by increasing the consistency of monitor application and oxygen administration during the placement of peripheral nerve blocks (PNBs), advance the knowledge of perianesthesia staff about PNB safety, and develop a PNB hospital policy.

DESIGN: QI project using the focus, analyze, develop, and execute model.

METHODS: The project had two parts, an educational component that was deployed in the three hospitals (hospital A, hospital B, hospital C) and an observation component that was conducted in only one of the hospitals (hospital A). Baseline observation of monitor and oxygen application was recorded at hospital A for 3 months. Assessment of perioperative personnel’s baseline knowledge regarding PNB safety was attained using a knowledge assessment tool in the three hospitals. Learners in the three hospitals were given a pretest and post-test to measure the change in knowledge level after a PNB safety presentation was given. Monitor and oxygen application during nerve block placements were observed and recorded after the PNB safety presentation at hospital A. Statistical analysis was completed to determine if significant differences in knowledge levels in the three hospitals and monitor and oxygen application at hospital A existed after an educational intervention was delivered to the perioperative teams.

FINDINGS: Participants’ knowledge level increased 13% overall with post-test scores greater than 90% after the educational intervention. Monitor application and administration of oxygen during PNB placement improved from 2% to 100% in a preliminary 3-week postintervention review. Systematic changes were implemented to facilitate adherence to best practice measures.

CONCLUSIONS: PNB safety presentations significantly improved staff’s knowledge regarding PNB procedures and potential problems. A multidisciplinary team approach was used to facilitate changes to improve electrocardiogram, blood pressure, pulse oximetry, and oxygen use in this patient population. A proposed PNB policy was accepted as a protocol. Patients are safer with increased monitoring.

PMID:33867246 | DOI:10.1016/j.jopan.2020.08.017

Clin Neurophysiol. 2021 Mar 26:S1388-2457(21)00464-8. doi: 10.1016/j.clinph.2021.02.389. Online ahead of print.

ABSTRACT

OBJECTIVE: This study investigates neurophysiological correlates of general and alcohol-specific inhibitory control in patients with Alcohol Use Disorder (AUD), focusing on its association with individual craving levels and with relapse at three-month follow-up.

METHODS: 59 abstinent AUD patients and 20 healthy controls performed a Go/NoGo task incorporating alcohol-related and neutral stimuli during 64-channel electroencephalography (EEG) recording, yielding four event-related potentials (ERP) per participant (NoGo-Alcohol, Go-Alcohol, NoGo-Neutral, Go-Neutral). Whole-scalp randomization-based statistics assessed effects of the factors group (patients/controls or relapsers/abstainers), craving level, response type (NoGo/Go) and picture type (alcohol/neutral) on topography and signal strength of the ERP components N2 and P3.

RESULTS: No differences on group level were observed between patients and controls. However, analyses incorporating individual craving indicated that the topographic difference between alcohol-related and neutral NoGo-N2 components increased with craving. Moreover, topographic differences in the alcohol-related and neutral NoGo-P3 component allowed for differentiation between relapsers and abstainers.

CONCLUSIONS: In alcohol-related contexts, the response inhibition conflict reflected in the NoGo-N2 seems enhanced in patients with high craving. The inhibition-sensitive NoGo-P3 varies in relapsers but not in abstainers between neutral and alcohol-related contexts.

SIGNIFICANCE: In AUD patients, neurophysiological correlates of inhibition vary with alcohol-related contexts and craving, and might be indicative of relapse risk.

PMID:33867254 | DOI:10.1016/j.clinph.2021.02.389

Eur Urol Focus. 2021 Apr 15:S2405-4569(21)00111-5. doi: 10.1016/j.euf.2021.04.005. Online ahead of print.

ABSTRACT

BACKGROUND: Correct identification of variant histologies (VHs) of bladder cancer (BCa) at transurethral resection of the bladder (TURB) could drive the subsequent treatment.

OBJECTIVE: To evaluate the concordance in detecting VHs between TURB and radical cystectomy (RC) specimens in BCa patients.

DESIGN, SETTING, AND PARTICIPANTS: We retrospectively analyzed 1881 BCa patients who underwent TURB and subsequent RC at seven tertiary care centers between 1980 and 2018. VHs were classified as sarcomatoid, lymphoepithelioma-like, neuroendocrine, squamous, micropapillary, glandular, adenocarcinoma, nested, and other variants.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Concordance between TURB and RC was defined as the ability to achieve histological subtypes at TURB confirmed at RC specimen, and was expressed according to Cohen’s kappa coefficient.

RESULTS AND LIMITATIONS: Of the patients, 14.6% and 21% were diagnosed with VH at TURB and RC specimens, respectively. The most common VHs at TURB were squamous, neuroendocrine, and micropapillary carcinoma (5.2%, 1.5%, and 1.5%, respectively). At RC, the most frequent VHs were squamous, micropapillary, and sarcomatoid carcinoma (7.2%, 3.0%, and 2.7%, respectively). The overall concordance in detecting VH was defined as slight concordance (coefficient: 0.18). Moderate concordance was found for neuroendocrine, adenocarcinoma, and squamous carcinoma (coefficient: 0.49, 0.47, and 0.41, respectively). Micropapillary, glandular, and other variants showed slight concordance (coefficient: 0.05, 0.17, and 0.12, respectively), while nested and sarcomatoid carcinoma showed fair concordance (coefficient: 0.32 and 0.26, respectively). Results may be limited by the absence of centralized pathological analysis.

CONCLUSIONS: A non-negligible percentage of patients were diagnosed with VH at both TURB and RC. TURB showed relatively low accuracy, ranging from poor to moderate, in detecting VHs. Our study underlines the need of additional diagnostic tools in order to identify VHs properly at precystectomy time and to improve patient survival outcomes.

PATIENT SUMMARY: In this report, we underlined the low accuracy of transurethral resection of the bladder in detecting variant histologies and the need for additional diagnostic tools.

PMID:33867307 | DOI:10.1016/j.euf.2021.04.005

J Arthroplasty. 2021 Mar 26:S0883-5403(21)00330-2. doi: 10.1016/j.arth.2021.03.047. Online ahead of print.

ABSTRACT

BACKGROUND: A small proportion of patients suffer from isolated lateral osteoarthritis where the sole lateral unicompartmental knee arthroplasty (UKA) is a possible treatment option. There, both a medial and a lateral surgical approach can be considered. This study should answer the question whether the lateral approach is superior to a modified medial approach in terms of implantation accuracy and subjective outcome.

METHODS: In this retrospective study, 175 patients with lateral UKA were included between 2015 and 2020. In 82 patients, the lateral approach was used, and in 93 patients, the medial approach was used. To assess implantation accuracy, different imaging criteria on postoperative radiographs were analyzed. Postoperative patient-related outcome measurements (PROMs) (OKS, LEFS, and EQ5D) were evaluated. Statistical significance was assumed for P < .05.

RESULTS: The tibial implant relation to the tibial plateau diameter in the lateral approach was significantly larger than in the medial approach (23.6% vs 22.2%; P < .001). Significantly more deviations >15° regarding flexion position of the femoral implant (P = .002) and a higher number of deviations of the slope was found (P = .06) in the lateral approach. The lateral approach showed a significantly higher rate of lateral positioning of the femoral component (P = .007). Post-PROMs showed significant improvement in both approaches.

CONCLUSION: The lateral approach is not superior regarding different radiological accuracy criteria. The Hoffa´s fat pad-preserving medial approach showed good results in implantation accuracy and therefore is a good alternative to implant lateral UKA. In addition, significant improvement in PROMs could be demonstrated.

PMID:33867207 | DOI:10.1016/j.arth.2021.03.047

Vaccine. 2021 Apr 15:S0264-410X(21)00345-5. doi: 10.1016/j.vaccine.2021.03.052. Online ahead of print.

ABSTRACT

VAQTA™ (Hepatitis A Vaccine, inactivated [HAVi]; Merck & Co., Inc., Kenilworth, NJ, USA) is currently licensed for prevention of disease caused by hepatitis A virus in persons ≥12 months of age. This report summarizes statistical models developed to evaluate the long-term persistence and duration of detectable hepatitis A antibody (total antibody levels with no distinction on class) after receipt of HAVi in healthy children and adolescents (V251-023 and V251-035) and in healthy adults (V251-034). The statistical models presented, conducted separately for each of the three studies, are based on models that have been used in the literature to estimate the duration of antibody to protect against human papillomavirus (HPV) disease. In the absence of observed study data on hepatitis A antibody persistence for vaccine recipients over several decades, an extrapolation from a kinetic model of antibody decay was used to estimate the duration of detectable antibody. Extrapolation of observed antibody titers from postvaccination, Year 2.5-3.5, Year 5-6, and Year 10 in 165 children and adolescents who received HAVi at Day 0 and Week 24 in V251-023 suggests that detectable levels of antibody may persist after the second dose for many years. This model suggests that 25 to 50 years Postdose 1 in a two-dose series of HAVi, 99.4% of the study population will have detectable levels of hepatitis A antibody.

PMID:33867215 | DOI:10.1016/j.vaccine.2021.03.052

Am J Orthod Dentofacial Orthop. 2021 Apr 16:S0889-5406(21)00101-3. doi: 10.1016/j.ajodo.2020.11.033. Online ahead of print.

ABSTRACT

INTRODUCTION: The objective of this research was to investigate the effectiveness of orthodontic miniscrews for skeletal anchorage during anterior open bite treatment using cephalometric radiographs.

METHODS: This study sample included 20 patients (mean age, 14.71; standard deviation, 1.77) with an anterior open bite. A total of 250 g of force was applied using elastic chains with anchorage from palatal miniscrew to an occlusal splint covering the posterior maxillary teeth. Cephalograms were obtained at the beginning of the treatment when the appliance was first applied and at the 8-month visit when treatment was completed. Paired t tests were used to identify statistically significant differences between initial and final measurements of skeletal and dental parameters.

RESULTS: A decrease of 2.72 ± 1.90° in the SN-GoGn angle and 3.63 ± 1.87 mm in the anterior height (N-Me) parameter in the cephalometric evaluations indicated a significant improvement of vertically increased facial dimensions, with the intrusion of the maxillary posterior teeth (P <0.05). Anterior rotation of the mandible was determined by a 1.76 ± 1.09° increase in the SNB angle and a 1.86 ± 0.90° decrease in the ANB angle (P <0.05). Reductions in the open bite amount by 5.8 ± 0.90 mm, Mx6-SN by 4.00 ± 1.01 mm, and Mx6-PP by 4.01 ± 1.00 mm were indicative of significant intrusion in the maxillary posterior teeth (P <0.05).

CONCLUSIONS: The present study confirmed that palatal miniscrew and maxillary occlusal splint caused intrusion of the maxillary posterior teeth, a decrease in the anterior open bite, and mandibular advancement, with anterior rotation after the maxillary posterior intrusion. We concluded that the treatment method in our study was appropriate for patients with Class I and mild Class II malocclusions and open bite anomalies.

PMID:33867217 | DOI:10.1016/j.ajodo.2020.11.033

Eur Urol. 2021 Apr 15:S0302-2838(21)00213-X. doi: 10.1016/j.eururo.2021.03.015. Online ahead of print.

ABSTRACT

BACKGROUND: Non-clear cell renal cell carcinoma (nccRCC) accounts for ≤20% of RCC cases. Lenvatinib (a multitargeted tyrosine kinase inhibitor) in combination with everolimus (an mTOR inhibitor) is approved for the treatment of advanced RCC after one prior antiangiogenic therapy.

OBJECTIVE: To determine the safety and efficacy of lenvatinib plus everolimus as a first-line treatment for patients with advanced nccRCC.

DESIGN, SETTING, AND PARTICIPANTS: This open-label, single-arm, multicenter, phase 2 study enrolled patients with unresectable advanced or metastatic nccRCC and no prior anticancer therapy for advanced disease.

INTERVENTION: Lenvatinib (18 mg) plus everolimus (5 mg) orally once daily.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the objective response rate (ORR) as assessed by investigators according to Response Evaluation Criteria in Solid Tumors version 1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety assessments. The 95% confidence intervals (CIs) for ORRs were calculated using the two-sided Clopper-Pearson method. Median PFS and median OS were estimated using the Kaplan-Meier product-limit method and their 95% CIs were estimated via a generalized Brookmeyer and Crowley method.

RESULTS AND LIMITATIONS: The study (start date: February 20, 2017) enrolled 31 patients with nccRCC (papillary, n = 20; chromophobe, n = 9; unclassified, n = 2). At the data cutoff date (July 17, 2019), the best overall response was a partial response (eight patients: papillary, n = 3; chromophobe, n = 4; unclassified, n = 1) for an overall ORR of 26% (95% CI 12-45). Median PFS was 9.2 mo (95% CI 5.5-not estimable), and median OS was 15.6 mo (95% CI 9.2-not estimable). The most common treatment-emergent adverse events were fatigue (71%), diarrhea (58%), decreased appetite (55%), nausea (55%), and vomiting (52%). Limitations include the small sample size and single-arm design.

CONCLUSIONS: Lenvatinib plus everolimus showed promising anticancer activity in patients with advanced nccRCC with an ORR of 26% and is worthy of further study. The safety profile was consistent with the established profile of the study-drug combination.

PATIENT SUMMARY: We examined the combination of lenvatinib plus everolimus as the first therapy for 31 patients who had advanced nccRCC. We found that this treatment seemed effective, because most patients had a decrease in tumor size and manageable treatment-related side effects.

CLINICAL REGISTRATION: This trial is registered at ClinicalTrials.Gov as NCT02915783.

PMID:33867192 | DOI:10.1016/j.eururo.2021.03.015

J Prosthet Dent. 2021 Apr 15:S0022-3913(21)00142-6. doi: 10.1016/j.prosdent.2021.02.033. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: Developing tapered implants with the most appropriate angular characteristics requires an improved analysis of the anatomy of premolar roots.

PURPOSE: The purpose of this observational study was to analyze the 3D anatomy of premolar roots by determining the tapered slope and convergent angle (TS/CA), to transform the TS/CA patterns into those in which the tapered implants mimic natural tooth roots, and to provide TS/CA references for future investigations.

MATERIAL AND METHODS: A total of 73 human single-rooted premolars were surveyed and analyzed by microcomputed tomography and an associated software program. The 3D root surface area (RSA), the radius/diameter (R/D) at the planned first to tenth millimeter levels apical to the cementoenamel junction (CEJ), and the TS/CA at corresponding levels were calculated. The results were statistically analyzed by using an independent samples t test to assess the general differences of tested parameters between maxillary and mandibular premolars. A paired t test was used to examine the significant intragroup TS/CA differences between sequential coronoapical levels. One-way ANOVA was applied to study the general significance of developmental patterns in maxillary and/or mandibular groups. Two-way ANOVA was used to inspect the TS/CA significance at various measurements coronoapically between the maxillary and mandibular premolars (α=.05).

RESULTS: Generally, the RSA, root length, R/D, and TS/CA parameters examined for the maxillary premolar roots differed significantly from those for the mandibular roots at the evaluated levels (P<.05). According to the measurements, the maxillary premolar roots generally exhibited nonsignificant RSA and R/D reduction patterns, with a decreasing angle of TS=13.44 degrees and CA=24.53 degrees coronoapically. However, mandibular premolar roots exhibited a significant reduction pattern, with TS=11.25 degrees and CA=21.06 degrees coronoapically according to both individual and general evaluations.

CONCLUSIONS: Based on the developmental patterns of the evaluated TSs/CAs, tapered implants imitating premolar root anatomy should have a conical rather than a cylindrical shape, and the R/D of these models should be reduced to half at the apical third. However, further studies are warranted to identify more TS/CA characteristics related to the tapered implants, including the TSs/CAs of other tooth types.

PMID:33867165 | DOI:10.1016/j.prosdent.2021.02.033