bluuebunny/crossref_metadata_2025_split huggingface dataset:
Sociodemographic Predictors of Treatment Success and Difficulty in Nasoalveolar Molding
Authors: Gibson Travis L. , Grayson Barry H. , Shetye Pradip R. 
Published: August 2020

Objective: To assess social and demographic influences on caregiver success and difficulty with nasoalveolar molding (NAM). Design: Retrospective review identified patients who began NAM between April 22, 2013, and April 18, 2017, at the New York University Langone Medical Center. Records were reviewed, and the following sociodemographic data retrieved: parental marital status, parental ages, number of siblings, distance traveled to clinic, insurance coverage, concurrent medical conditions, and need for an interpreter. Patients: Patients were included if complete charting was available; 106 patients met the inclusion criteria; 79 patients with unilateral and 27 with bilateral clefts. Outcome Measures: Chart entries indicating incorrect appliance usage, emergency visits, phone calls, and noncompliance were recorded. Alveolar cleft gap closure was measured on pre- and posttreatment models in unilateral cases. Multiple regression analyses were performed to assess the influence of social variables on these outcomes. Results: Alveolar cleft gap closure was 7.2 ± 3.0 mm, or 78.5% ± 19.1%. Cleft closure increased with paternal age by 0.33 mm ( P = .007) or 2.0% ( P = .017) per year, decreased with maternal age by 0.29 mm ( P = .041) per year, and increased in married and partnered parents by 39% ( P = .018). Incorrect appliance usage averaged 0.62 fewer instances for married and partnered parents ( P = .018) and 0.43 fewer for those with private insurance ( P = .019). Conclusions: Alveolar cleft gap closure was more successful for older fathers, younger mothers, and married couples. Married couples were also less likely to experience treatment difficulties such as incorrect appliance usage or inadequate duration of wear, as were those with private insurance coverage.
Factors associated with positive urine cultures in cats with subcutaneous ureteral bypass system implantation
Authors: Pennington Catrina E , Halfacree Zoe , Colville-Hyde Charlotte , Geddes Rebecca F 
Published: August 2020

Objectives The aims of this study were to report the postoperative incidence of subcutaneous ureteral bypass (SUB)-associated bacteriuria and risk factors in a large population of UK cats, to identify the commonly implicated isolates in these cases and to report associations of positive postoperative urine cultures with device occlusion or a need for further surgery. Methods Electronic clinical records were reviewed to identify cats with ureteral obstruction that underwent unilateral or bilateral SUB implantation between September 2011 and September 2019. In total, 118 client-owned cats were included in the study population. Information recorded included signalment, history, surgical and biochemical factors, urinalysis and culture results. Multivariable logistic regression was performed to identify variables associated with a positive postoperative culture. Results In total, 10 cats (8.5%) had a positive postoperative culture within 1 month postsurgery and 28 cats (23.7%) within 1 year postsurgery. Cats with a positive preoperative culture were significantly more likely to have a positive culture within 6 months postoperatively (odds ratio [OR] 4.09, 95% confidence interval [CI] 1.18–14.18; P = 0.026). Of the 14 cats with a positive preoperative culture, six (42.9%) returned a positive culture within 1 year postoperatively, and in four cases (66.7%) the same isolate was identified. Cats with a higher end-anaesthetic rectal temperature were significantly less likely to return a positive culture within 3 months (OR 0.398, 95% CI 0.205–0.772; P = 0.006) postsurgery. Cats culturing positive for Escherichia coli at any time point (OR 4.542, 95% CI 1.485–13.89; P = 0.008) were significantly more likely to have their implant removed or replaced. Conclusions and relevance Perioperative hypothermia and preoperative positive culture were independent predictors of a postoperative positive culture and this should be taken into consideration when managing these cases. Positive postoperative culture rates were higher than have previously been reported.
Effects of the first month of lockdown for COVID-19 in Italy: A preliminary analysis on the eyecare system from six centers
Authors: dell’Omo Roberto , Filippelli Mariaelena , Semeraro Francesco , Avitabile Teresio , Giansanti Fabrizio , Parmeggiani Francesco , Romano Mario R , Strianese Diego , Romano Vito , Virgili Gianni , Costagliola Ciro 
Published: August 2020

Purpose: To compare the number of eye surgical procedures performed in Italy during the first month of lockdown with those performed in the same period in 2019. Methods: Review of the surgical procedures performed from 10 March to 9 April 2019 and from 10 March to 9 April 2020 (the first month of lockdown because of the COVID-19 outbreak) at six academic institutional centers of Italy. A distinction was made between urgent procedures: any trauma repairment, trabeculectomy/drainage implant for glaucoma, any operation for rhegmatogenous retinal detachment (RRD) repair, pars plana vitrectomy (PPV) for vitreous hemorrhage (VH), macular hole, or retained lens fragments; elective procedures: corneal transplant, phacoemulsification for cataract extraction, silicone oil removal, and PPV for epiretinal membrane; and intravitreal injections (either anti-vascular endothelial growth factor [VEGF] or dexamethasone) to treat exudative maculopathies. The main outcome measure was the rate of reduction in urgent and elective surgeries performed. Results: Overall, 3624 and 844 surgical procedures were performed from 10 March to 9 April 2019 and from 10 March to 10 April 2020, respectively (−76.7% in 2020 compared to 2019, p < 0.0001). Urgent and elective surgical procedures and intravitreal injections of anti-VEGF drugs or dexamethasone reduced significantly in 2020 in comparison to 2019 ( p < 0.0001 for urgent and elective surgeries and 0.01 for intravitreal injections). Conclusion: A significant reduction in the rate of urgent and elective surgeries and intravitreal injections was recorded during the first month of lockdown compared to the same period in 2019. With this analysis, the authors hope to provide some preliminary insights about the consequences of lockdown for the eyecare system in Italy.
Carotid Plaque Morphology is Similar in Patients with Reduced and Normal Renal Function
Authors: Heijl Caroline , Kahn Fredrik , Edsfeldt Andreas , Tengryd Christoffer , Nilsson Jan , Goncalves Isabel 
Published: August 2020

Background: Chronic Kidney Disease (CKD) is associated with an increased risk for cardiovascular events such as stroke. However, it is still unclear if decreased kidney function is associated with a vulnerable atherosclerotic plaque phenotype. To explore if renal function was associated with carotid plaque vulnerability we analyzed carotid plaques obtained at surgery from the Carotid Plaque Imaging Project (CPIP). Methods: Patients were enrolled through the CPIP cohort. The indication for surgery was plaques with stenosis >70%, associated with ipsilateral symptoms or plaques with stenosis >80% not associated with symptoms. Transversal sections from the most stenotic plaque region were analyzed for connective tissue, calcium, lipids, macrophages, intraplaque hemorrhage, and smooth muscle cells. Homogenates were analyzed for collagen and elastin. Results: Carotid endarterectomy specimens from 379 patients were obtained. The median GFR was 73 ml/min/1.73 m2. Plaque characteristics showed no significant association with eGFR, neither when eGFR was divided in CKD groups nor when eGFR was handled as a continuous variable and adjusting for other known risk factors (ie, age, diabetes, hypertension, and smoking). Conclusions: The higher risk of cardiovascular disease such as stroke in CKD is not associated with increased plaque vulnerability and other factors have to be sought.
Genetic Heterogeneity Between Paired Primary and Brain Metastases in Lung Adenocarcinoma
Authors: Li Li , Liu Zhulin , Han Rui , Li Lin , Wang Mengyao , Huang Depei , He Yong 
Published: August 2020

Purpose: About one-third of nonsmall cell lung cancer (NSCLC) patients develop brain metastases (BM). However, there is an unmet need for early diagnosis and treatment of BM. The precise mechanism for BM is still unknown. However, the genetic heterogeneity between primary tumor and paired BM indicates that sampling from the primary tumor may not be able to fully represent the mutational status in metastases. In this study, the genetic heterogeneity of primary lung adenocarcinoma and paired BM was analyzed. Patients and methods: A total of 11 paired samples of primary tumors and BM from lung cancer patients were included, in which 7 paired samples of patients were finally analyzed. Samples were sequenced by whole-exome sequencing (WES) to investigate the common and unique mutations in the primary tumors and BM, and the similarities and differences in copy number variation (CNV). Results: The consistency of gene mutation between primary lung adenocarcinoma and paired BM was 33% to 86%. FAM129C and ADAMTSs specifically mutated in BM, along with NKX2-1 high amplification and SAMD2/4 copy number deletion. Conclusion: The consistency of gene mutation between primary lung adenocarcinoma and corresponding BM is relatively high, while the individual differences were significant. FAM129C and ADAMTSs mutations and high amplification of NKX2-1 may be related to BM of lung cancer. The loss of copy number of SAMD2/4 may be a potential therapeutic target for BM from lung adenocarcinoma.
Prognostic Significance of Preoperative Neutrophil-Lymphocyte Ratio in Vascular Surgery: Systematic Review and Meta-Analysis
Authors: Jackson Sarah M. , Perry Luke A. , Borg Carla , Ramson Dhruvesh M. , Campbell Ryan , Liu Zhengyang , Nguyen Jacqueline , Douglas Ned , Kok Juliana , Penny-Dimri Jahan 
Published: August 2020

Objective: The global burden of surgical vascular disease is increasing and with it, the need for cost-effective, accessible prognostic biomarkers to aid optimization of peri-operative outcomes. The neutrophil-lymphocyte ratio (NLR) is emerging as a potential candidate biomarker for perioperative risk stratification. We therefore performed this systematic review and meta-analysis on the prognostic value of elevated preoperative NLR in vascular surgery. Methods: We searched Embase (Ovid), Medline (Ovid), and the Cochrane Library database from inception to June 2019. Screening was performed, and included all peer-reviewed original research studies reporting preoperative NLR in adult emergent and elective vascular surgical patients. Studies were assessed for bias and quality of evidence using a standardized tool. Meta-analysis was performed by general linear (mixed-effects) modelling where possible, and otherwise a narrative review was conducted. Between-study heterogeneity was estimated using the Chi-squared statistic and explored qualitatively. Results: Fourteen studies involving 5,652 patients were included. The overall methodological quality was good. Elevated preoperative NLR was associated with increased risk of long-term mortality (HR 1.40 [95%CI: 1.13-1.74], Chi-squared 60.3%, 7 studies, 3,637 people) and short-term mortality (OR: 3.08; 95%CI: 1.91-4.95), Chi-squared 66.59%, 4 studies, 945 people). Outcome measures used by fewer studies such as graft patency and amputation free survival were assessed via narrative review. Conclusions: NLR is a promising, readily obtainable, prognostic biomarker for mortality outcomes following vascular surgery. Heterogeneity in patient factors, severity of vascular disease, and type of vascular surgery performed renders direct comparison of outcomes from the current literature challenging. This systematic review supports further investigation for NLR measurement in pre-vascular surgical risk stratification. In particular, the establishment of a universally accepted NLR cut-off value is of importance in real-world implementation of this biomarker.
Comparison of paclitaxel-coated balloon angioplasty with femoropopliteal bypass surgery in treating femoropopliteal lesions
Authors: Kavala Ali Aycan , Kuserli Yusuf , Turkyilmaz Saygin 
Published: August 2020

Objective To compare drug (paclitaxel)-coated balloon angioplasty with femoropopliteal bypass surgery in the treatment of femoropopliteal lesions. Methods A retrospective study was performed between January 2015 and January 2019, covering a four-year period. All subjects who underwent femoropopliteal bypass surgery and drug-coated balloon angioplasty over a four-year period were evaluated. The subjects’ demographic characteristics, lesion characteristics, treatment outcomes and disease-free survival were collected. Subjects were divided into the femoropopliteal bypass group (Group A) and the drug-coated balloon angioplasty (Group B) group. Results In total, 220 subjects were enrolled. Both Group A and Group B consisted of 110 subjects. The proportion of patients with a claudication distance between 0 and 50 m was significantly higher in Group A, and the proportion of patients with a claudication distance between 50 and 100 m was significantly higher in Group B ( p = 0.001). In terms of the Rutherford levels, moderate claudication was significantly higher in Group B, and severe claudication was significantly higher in Group A ( p = 0.001). The lesion length for the subjects in Group A was significantly longer than that in Group B (24.61 ± 2.79 mm for Group A and 18.59 ± 3.95 mm for Group B, p = 0.001). The stenosis degree in Group A was also significantly higher than that in Group B (96.82 ± 4.32% for Group A and 94.85 ± 4.55% for Group B, p = 0.001). The duration of the procedure, duration of hospitalization and rate of bleeding in Group A were significantly higher than those in Group B. The incidence of overall morbidity and reintervention rates in Group B were significantly higher than that in Group A. The preoperative ankle brachial index values of the subjects in Group B were statistically significantly higher than those in Group A (0.56 ± 0.08 for Group A and 0.61 ± 0.08 for Group B, p = 0.001). The change in the ankle brachial index measurement of the subjects in Group A with respect to the preprocedure value was significantly greater than that in Group B ( p = 0.001). For primary patency, there was a significant difference between the groups in the distribution of the duplex ultrasound results at the 3rd, 6th, 9th and 12th month control points ( p = 0.001). At all control points, Group A had better primary patency rates, whereas the secondary patency rates did not differ. In total, among the 220 patients, 125 (56.8%) were disease free, and 95 (43.2%) experienced recurrence. The mean disease-free survival times for Group A and Group B were 10.45 ± 0.28 months and 9.11 ± 0.37 months, respectively. The disease-free survival rates were significantly higher in Group A ( p = 0.001, p < 0.05). Conclusion Femoropopliteal bypass resulted in better disease-free survival rates than drug-coated balloon angioplasty and serves as an effective modality for the treatment of femoropopliteal lesions.
Intent-to-treat analysis of cluster randomized trials when clusters report unidentifiable outcome proportions
Authors: DeSantis Stacia M , Li Ruosha , Zhang Yefei , Wang Xueying , Vernon Sally W , Tilley Barbara C , Koch Gary 
Published: August 2020

Background Cluster randomized trials are designed to evaluate interventions at the cluster or group level. When clusters are randomized but some clusters report no or non-analyzable data, intent-to-treat analysis, the gold standard for the analysis of randomized controlled trials, can be compromised. This article presents a very flexible statistical methodology for cluster randomized trials whose outcome is a cluster-level proportion (e.g. proportion from a cluster reporting an event) in the setting where clusters report non-analyzable data (which in general could be due to nonadherence, dropout, missingness, etc.). The approach is motivated by a previously published stratified randomized controlled trial called, “The Randomized Recruitment Intervention Trial (RECRUIT),” designed to examine the effectiveness of a trust-based continuous quality improvement intervention on increasing minority recruitment into clinical trials (ClinicalTrials.gov Identifier: NCT01911208). Methods The novel approach exploits the use of generalized estimating equations for cluster-level reports, such that all clusters randomized at baseline are able to be analyzed, and intervention effects are presented as risk ratios. Simulation studies under different outcome missingness scenarios and a variety of intra-cluster correlations are conducted. A comparative analysis of the method with imputation and per protocol approaches for RECRUIT is presented. Results Simulation results show the novel approach produces unbiased and efficient estimates of the intervention effect that maintain the nominal type I error rate. Application to RECRUIT shows similar effect sizes when compared to the imputation and per protocol approach. Conclusion The article demonstrates that an innovative bivariate generalized estimating equations framework allows one to implement an intent-to-treat analysis to obtain risk ratios or odds ratios, for a variety of cluster randomized designs.
Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials
Authors: Bikdeli Behnood , Caraballo César , Welsh John , Ross Joseph S , Kaul Sanjay , Stone Gregg W , Krumholz Harlan M 
Published: August 2020

Background/aims Non-inferiority trials are increasing in cardiovascular medicine, with approval of many drugs and devices on the basis of such studies. Surrogate markers as primary endpoints have been also more frequently used for efficient assessment of cardiovascular interventions. However, there is uncertainty about their concordance with clinical outcomes. Non-inferiority design using a surrogate marker as a primary endpoint may pose particular challenges in clinical interpretation. We sought to explore the publication trends, methodology, and reporting features of non-inferiority cardiovascular trials that used a primary surrogate marker as the primary endpoint. Methods We searched six high-impact journals ( The New England Journal of Medicine, The Journal of the American Medical Association, The Lancet, The Journal of the American College of Cardiology, Circulation, and European Heart Journal) from 1 January 1990 to 31 December 2018 and identified non-inferiority cardiovascular trials that used a surrogate marker as the primary endpoint. We assessed the non-inferiority margin reported in the manuscript and other publicly available platforms (e.g. protocol, clinicaltrials.gov). We also determined whether the included non-inferiority trials with surrogate markers as primary endpoints were followed by clinical outcome trials. Results We screened 15,553 publications and identified 247 cardiovascular trials that used a non-inferiority design. Of these, 37 had a surrogate marker as a primary endpoint (18 drug trials, 13 device trials, 6 others). All of these non-inferiority trials with surrogate outcomes were published after 2000, mostly in cardiology journals (13 in The Journal of the American College of Cardiology, 9 in European Heart Journal, 8 in Circulation, 6 in The Lancet, 1 in The New England Journal of Medicine), and their publication rate increased over time (p < 0.001 for linear trend). The median number of patients in the primary analysis was 300 (interquartile range: 202–465). The study protocol or a methods paper was publicly available for only 13 (35.1%) trials, of which the non-inferiority margin was not reported in 4 trials. In 16 studies (43.2%), the manuscript did not acknowledge the limitations of using a surrogate endpoint or the need for a definitive clinical outcome trial. Thirty-four trials (91.9%) concluded that the tested intervention met non-inferiority criteria. However, only five (13.5%) were followed by clinical outcomes trials the results of which did not always confirm non-inferiority. Conclusion Non-inferiority trials that use a surrogate marker as the primary endpoint are being increasingly performed. However, these trials pose particular challenges with design, reporting, and interpretation, which are not systematically and consistently addressed or reported.
Effect of ACL Reconstruction on Range of Tibial Rotation: A Systematic Review of Current Literature and a Recommendation for a Standard Measuring Protocol
Authors: Zee Mark J.M. , Robben Bart J. , Zuurmond Rutger G. , Bulstra Sjoerd K. , Diercks Ronald L. 
Published: August 2020

Background: Tibial rotation is an important topic in anterior cruciate ligament (ACL) surgery, and many efforts are being made to address rotational stability. The exact role of the ACL in controlling tibial rotation in clinical studies is unknown. Purpose: To quantify the effect of ACL reconstruction on the amount of tibial rotation based on the current available literature. Study Design: Systematic review; Level of evidence, 4. Methods: A literature search of the PubMed and EMBASE databases was performed in August 2019. Two independent reviewers reviewed titles and abstracts as well as full-text articles. A total of 2383 studies were screened for eligibility. After screening of titles and abstracts, 178 articles remained for full-text assessment. Ultimately, 13 studies were included for analysis. A quality assessment was performed by means of the RoB 2.0 (revised tool for Risk of Bias in randomized trials) and the ROBINS-I (Risk Of Bias In Non-randomized Studies–of Interventions) tools. Results: According to the studies using computer-assisted surgery that were included in this review, ACL reconstruction resulted in an average reduction in tibial rotation of 17% to 32% compared with preoperatively; whether the range of tibial rotation returned to preinjury levels remained unclear. In the current literature, a gold standard for measuring tibial rotation is lacking. Major differences between the study protocols were found. Several techniques for measuring tibial rotation were used, each with its own limitations. Most studies lacked proper description of accompanying injuries. Conclusion: ACL reconstruction reduced the range of tibial rotation by 17% to 32%. Normal values for the range of tibial rotation in patients with ACL deficiency and those who undergo ACL reconstruction could not be provided based on the current available literature owing to a lack of uniform measuring techniques and protocols. Therefore, we advocate uniformity in measuring tibial rotation.