bluuebunny/crossref_metadata_2025_split huggingface dataset:
In vitro comparison of the torsional load transfer of various commercially available stainless-steel wires used for fixed retainers in orthodontics
Authors: Engeler Olivia G , Dalstra Michel , Arnold Dario T , Steineck Markus , Verna Carlalberta 
Published: November 2020

Objective: To assess the torsional load transfer of various commercially available stainless-steel wires used for fixed retainers. Design: An in vitro study using a robotic device. Setting: Department of Pediatric Oral Health and Orthodontics, University of Basel. Methods: A 10° proclination of a maxillary lateral incisor of a 2-2 retainer was simulated with a robotic device. Eight stainless-steel wires with different shapes (round or rectangular), types (plain, braided, coaxial or chain) and dimensions were selected to measure the torsional load transfer at the adjacent central incisor. The influence of annealing was also tested. Results: The 0.016 × 0.016 and Bond-A-Braid™ wires (0.02645 × 0.01055-inch, 8-stranded, braided) showed the largest relative torsional load transfer (3.7% and 3.3%, respectively). The two multistranded wires - Triple Flex™ and Respond® - showed the smallest values of 1.0% and 0.7%, respectively. The spiral direction of these two multistranded wires affected the load transfer, the twisting showing larger torsional load transfer than the untwisting one. Conclusion: The effective torsional load transfer depends on the dimension, shape and type of a wire. Plain and braided retainers were more predictable in torsional load transfer than multistranded retainers, which may have stored more energy in the area between the composite bonding sites. This may explain the unexpected complications reported in multistranded retainers.
Bilateral Vein Compression by Popliteal Artery Aneurisms Mimicking Post-Thrombotic Syndrome
Authors: Gonzalez-Urquijo Mauricio , Cassagne Gabriela , Lozano-Balderas Gerardo , Fabiani Mario Alejandro 
Published: November 2020

Purpose: To report a case of a 79-year-old man who presented a bilateral popliteal artery aneurysm compressing both popliteal veins mimicking signs and symptoms of post-thrombotic syndrome. Case Report: A 79-year-old male patient, was seen in the ambulatory clinic with a 2-year history of bilateral leg swelling, calf pain, chronic ulceration, and hyperpigmentation. Upon physical examination, lower extremities were edematous, with a 3 cm suppurative ulcer on each leg. Image studies showed a popliteal right arterial aneurysm of maximum diameter of 41.7 mm, extrinsically compressing the ipsilateral popliteal vein. Likewise, on the left leg, a popliteal arterial aneurysm of maximum diameter of 47.9 mm was encountered triggering the same phenomenon. Bilateral endovascular treatment deploying stent grafts was auspiciously performed. At 36-months follow up, his symptoms are completely resolved, and his ulcers healed. US follow up showed exclusion of the aneurysms with progressive shrinkage of both residual sacs. Conclusion: Popliteal artery aneurysm compressing and constraining flow in the popliteal vein must be included as a differential diagnosis among the causes of chronic venous syndromes. Prompt diagnosis with its appropriate treatment is needed for reducing severe complications caused by PAA, such as the venous disorder our patient had.
Utilization Rates of Diagnostic and Therapeutic Vascular Procedures Among Patients Undergoing Lower Extremity Amputations in a Rural Community Hospital: A Clinicopathological Correlation
Authors: Varghese Joji J. , Estes Bailey Ann , Martinsen Brad J. , Igyarto Zsuzsanna , Mustapha Jihad , Saab Fadi , Naidu Srihari S. 
Published: November 2020

Background: Significant geographical variations exist in amputation rates and utilization of diagnostic and therapeutic vascular procedures before lower extremity amputations in the United States. The purpose of this study was to evaluate the rates of diagnostic and therapeutic vascular procedures in the year prior to amputation in a contemporary population and correlate with pathological findings of the amputation specimens. Methods: A retrospective analysis was conducted of non-traumatic amputations from 2011 to 2017 at a rural community hospital. We reviewed the proportion of patients undergoing diagnostic (ankle brachial index with duplex ultrasound, computerized tomography angiogram and invasive angiogram) and therapeutic (endovascular and surgical revascularization) vascular procedures in the year prior to amputation. Prevalence of tissue viability and osteomyelitis were evaluated in all amputated specimens and atherosclerotic vascular disease (ASVD) was evaluated in major amputations. We also analyzed primary amputation rates among different subgroups. Results: 698 patients were included with 248 (36%) major amputations and 450 (64%) minor amputations. Any diagnostic procedure was performed in 59% of the major amputations and 49% of the minor amputations (P = 0.01). Any therapeutic revascularization procedure was performed in 34% of the major amputations and 28% of the minor amputations (P = 0.08). The pathology of major amputation specimens revealed severe ASVD in 57% and mild-moderate ASVD in 27% of specimens. Tissue viability was significantly higher in major amputations (90% vs 30%, P = 0.04) and osteomyelitis was significantly higher in minor amputations (50% vs 14%, P = 0.03). Primary amputations were performed in 66% of major amputations, 72% of minor amputations, 81% with mild to moderate ASVD and 54% with severe ASVD. Conclusion: Diagnostic and therapeutic vascular procedures appear under-utilized for patients undergoing lower extremity amputations at a rural community hospital. ASVD rates and tissue viability imply that revascularization could be of significant benefit to avoid major amputation.
Bayesian biomarker-driven outcome-adaptive randomization with an imperfect biomarker assay
Authors: Garcia Barrado Leandro , Burzykowski Tomasz 
Published: November 2020

Objective: We investigate the impact of biomarker assay’s accuracy on the operating characteristics of a Bayesian biomarker-driven outcome-adaptive randomization design. Methods: In a simulation study, we assume a trial with two treatments, two biomarker-based strata, and a binary clinical outcome (response). P bt denotes the probability of response for treatment t ( t = 0 or 1) in biomarker stratum ( b = 0 or 1). Four different scenarios in terms of true underlying response probabilities are considered: a null ( P00 = P01 = 0.25, P10 = P11= 0.25) and consistent ( P00 = P10 = 0.25, P01 = 0.5) treatment effect scenario, as well as a quantitative ( P00 = P01 = P10 = 0.25, P11 = 0.5) and a qualitative ( P00 = P11 = 0.5, P01 = P10 = 0.25) stratum-treatment interaction. For each scenario, we compare the case of a perfect with the case of an imperfect biomarker assay with sensitivity and specificity of 0.8 and 0.7, respectively. In addition, biomarker-positive prevalence values P( B = 1) = 0.2 and 0.5 are investigated. Results: Results show that the use of an imperfect assay affects the operational characteristics of the Bayesian biomarker-based outcome-adaptive randomization design. In particular, the misclassification causes a substantial reduction in power accompanied by a considerable increase in the type-I error probability. The magnitude of these effects depends on the sensitivity and specificity of the assay, as well as on the distribution of the biomarker in the patient population. Conclusion: With an imperfect biomarker assay, the decision to apply a biomarker-based outcome-adaptive randomization design may require careful reflection.
Details of risk–benefit communication in informed consent documents for phase I/II trials
Authors: Kahrass Hannes , Bossert Sabine , Schürmann Christopher , Strech Daniel 
Published: November 2020

Background: Informed consent documents for clinical studies should disclose all reasonably foreseeable risks and benefits. Little guidance exists on how to navigate the complexities of risk–benefit communication, especially in early clinical research. Practice-oriented development of such guidance should be informed by evidence on what and how details of risks and benefits are currently communicated. Method: We surveyed the responsible parties of phase I/II trials registered in ClinicalTrials.gov that started 2007 or later and completed between 2012 and 2016 to sample informed consent documents from a broad spectrum of early phase clinical trials. Based on an assessment matrix, we qualitatively and quantitatively assessed the informed consent documents for details of risk–benefit communication. Results: The risk–benefit communication in the 172 informed consent documents differed substantially in several regards. The outcome, extent, and likelihood of health risks, for example, were described in 83%, 32%, and 63% of the informed consent documents. Only 45% of informed consent documents specified the outcome of mentioned health benefits, and the extent and likelihood of health benefits were never specified. From those informed consent documents reporting risk likelihoods, only 57% added frequency numbers to words such as “common” or “rare,” and even in these cases, we found strong variations for presented frequency ranges. Substantial heterogeneity also exists for how informed consent documents communicate other risk and benefit types and related safeguards. Conclusion: Our study points to several shortcomings and heterogeneities in how informed consent documents communicate risks and benefits to potential research participants. Health risks, for example, should be specified with frequency numbers, and health benefits should be specified at least by mentioning their outcomes. Further demand for research and policy development is needed to harmonize risk–benefit communication and to clarify ways to specify the likelihood of health benefits.
Event-specific win ratios and testing with terminal and non-terminal events
Authors: Yang Song , Troendle James 
Published: November 2020

Background/aims In clinical trials, the primary outcome is often a composite endpoint defined as time to the first occurrence of either death or certain non-fatal events. Thus, a portion of available data would be omitted. In the win ratio approach, priorities are given to the clinically more important events, and more data are used. However, its power may be low if the treatment effect is predominantly on the non-terminal event. Methods We propose event-specific win ratios obtained separately on the terminal and non-terminal events. They can then be used to form global tests such as a linear combination test, the maximum test, or a [Formula: see text] test. Results In simulations, these tests often improve the power of the original win ratio test. Furthermore, when the terminal and non-terminal events experience differential treatment effects, the new tests are often more powerful than the log-rank test for the composite outcome. Whether the treatment effect is primarily on the terminal events or not, the new tests based on the event-specific win ratios can be useful when different types of events are present. The new tests can reject the null hypothesis of no difference in the event distributions in the two treatment arms with the terminal event showing detrimental effect and the non-terminal event showing beneficial effect. The maximum test and the [Formula: see text] test do not have test-estimation coherency, but the maximum test has the coherency that the global null is rejected if and only if the null for one of the event types is rejected. When applied to data from the trial Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function (TOPCAT), the new tests all reject the null hypothesis of no treatment effect while both the log-rank test used in TOPCAT and the original win ratio approach show non-significant p-values. Conclusion Whether the treatment effect is primarily on the terminal events or the non-terminal events, the maximum test based on the event-specific win ratios can be a useful alternative for testing treatment effect in clinical trials with time-to-event outcomes when different types of events are present.
Economic evaluation of extended electrocardiogram monitoring for atrial fibrillation in patients with cryptogenic stroke
Authors: Chew Derek S , Rennert-May Elissa , Quinn F Russell , Buck Brian , Hill Michael D , Spackman Eldon , Manns Braden J , Exner Derek V 
Published: November 2020

Background Timely identification of occult atrial fibrillation following cryptogenic stroke facilitates consideration of oral anticoagulation therapy. Extended electrocardiography monitoring beyond 24 to 48 h Holter monitoring improves atrial fibrillation detection rates, yet uncertainty remains due to upfront costs and the projected long-term benefit. We sought to determine the cost-effectiveness of three electrocardiography monitoring strategies in detecting atrial fibrillation after cryptogenic stroke. Methods A decision-analytic Markov model was used to project the costs and outcomes of three different electrocardiography monitoring strategies (i.e. 30-day electrocardiography monitoring, three-year implantable loop recorder monitoring, and conventional Holter monitoring) in acute stroke survivors without previously documented atrial fibrillation. Results The lifetime discounted costs and quality-adjusted life years were $206,385 and 7.77 quality-adjusted life years for conventional monitoring, $207,080 and 7.79 quality-adjusted life years for 30-day extended electrocardiography monitoring, and $210,728 and 7.88 quality-adjusted life years for the implantable loop recorder strategy. Additional quality-adjusted life years could be attained at a more favorable incremental cost per quality-adjusted life year with the implantable loop recorder strategy, compared with the 30-day electrocardiography monitoring strategy, thereby eliminating the 30-day strategy by extended dominance. The implantable loop recorder strategy was associated with an incremental cost per quality-adjusted life year gained of $40,796 compared with conventional monitoring. One-way sensitivity analyses indicated that the model was most sensitive to the rate of recurrent ischemic stroke. Conclusions An implantable loop recorder strategy for detection of occult atrial fibrillation in patients with cryptogenic stroke is more economically attractive than 30-day electrocardiography monitoring compared to conventional monitoring and is associated with a cost per quality-adjusted life year gained in the range of other publicly funded therapies. The value proposition is improved when considering patients at the highest risk of recurrent ischemic stroke. However, the implantable loop recorder strategy is associated with increased health care costs, and the opportunity cost of wide scale implementation must be considered.
A phase III, randomized, double-blind, controlled trial of carboxyamidotriazole plus chemotherapy for the treatment of advanced non-small cell lung cancer
Authors: Si Xiaoyan , Wang Jinwan , Cheng Ying , Shi Jianhua , Cui Liying , Zhang Helong , Huang Yunchao , Liu Wei , Chen Lei , Zhu Jiang , Zhang Shucai , Li Wei , Sun Yan , Wang Hanping , Zhang Xiaotong , Wang Mengzhao , Yang Lin , Zhang Li 
Published: November 2020

Background: Carboxyamidotriazole (CAI), a calcium channel blocker, inhibits tumor cell proliferation, metastasis, and angiogenesis. This trial aimed to determine whether CAI combined with conventional chemotherapy could prolong progression-free survival (PFS) in non-small cell lung cancer (NSCLC) patients. Methods: Patients were assigned into groups (3:1 ratio) to receive either chemotherapy + CAI or chemotherapy alone. Cisplatin (25 mg/m2) was administered by intravenous infusion on days 1, 2, and 3, and vinorelbine (25 mg/m2) on days 1 and 8 of each 3-week cycle for four cycles. CAI was administered at 100 mg daily with concomitant chemotherapy; this treatment was continued after chemotherapy was ceased until serious toxicity or disease progression had occurred. PFS was the primary endpoint, and the secondary endpoints were objective response rate (ORR), disease control rate, overall survival (OS), and quality of life. Results: In total, 495 patients were enrolled in the trial: 378 in the chemotherapy + CAI group and 117 in the chemotherapy + placebo group. PFS was significantly greater in the chemotherapy + CAI [median, 134 days; 95% confidence interval (CI) 127–139] than in the chemotherapy + placebo (median, 98 days; 95% CI: 88–125) group, with a hazard ratio of 0.690 (95% CI: 0.539–0.883; p = 0.003). There was no difference in the OS rates of both groups. The ORR was greater in the chemotherapy + CAI group than in the chemotherapy + placebo group (34.6% versus 25.0%, p = 0.042). Adverse events of ⩾grade 3 occurred more frequently in the CAI group [256 (68.1%) versus 64 (55.2%); p = 0.014]. Conclusion: CAI + platinum-based chemotherapy prolonged PFS and could be a useful therapeutic option to treat NSCLC. Clinical Trial Registration: chinadrugtrials.org.cn identifier: CTR20160395
Diagnostic Yield of Neck CT Angiography in Young Adults With Anterior Circulation Ischemic Stroke: A Community Based Study
Authors: Schenk William B. , Brinjikji Waleed , Larson Anthony S. , Nasr Deena M. 
Published: November 2020

Background and Purpose: Few community-based studies investigating young adult strokes exist. The aim of this study was to determine the diagnostic yield of head and neck CTA in evaluation of anterior circulation ischemic stroke in young adults. Materials and Methods: This retrospective review is limited to patients between the ages of 18-50 presenting to the Mayo Clinic Rochester emergency department or referred from smaller institutions in adjacent counties. Patients with posterior circulation infarcts, amaurosis fugax, central retinal artery occlusion or transient ischemic attacks were excluded. The presence of carotid dissection, webs, plaque, or other high-risk lesions were recorded. Results: A total of 136 patients met inclusion criteria. Mean degree of carotid stenosis ipsilateral to infarct was 14.1%, compared to 6.5% on the contralateral side (p = .006). Ipsilateral mean carotid wall thickness measured .79 mm, compared to contralateral thickness of .80 mm (p = .51). Ipsilateral low-density plaque was observed in 22 patients (16.2%), and 21 patients (15.4%) on the contralateral side (p = .87). Ipsilateral calcified plaque was observed in 37 patients (27.2%), and 29 patients (21.3%) on the contralateral side (p = .31). 20 (14.7%) ipsilateral dissections were noted, compared to 4 (2.9%) contralateral dissections (p = .001). 3 (2.2%) ipsilateral carotid webs were identified, compared to 0 contralateral webs (p = .25). Conclusion: Carotid dissection was the most common cause of anterior circulation infarct identified on cervical CTA in this population. Carotid webs and atherosclerosis were not common findings.
Patterns of thromboembolic pulmonary vascular disease in COVID‐19
Authors: Shahin Yousef , Rajaram Smitha , Parkash Vivak , Wild James M , Kiely David G , Swift Andrew J 
Published: November 2020

SARS‐CoV‐2 (COVID‐19) is associated with increased thrombosis. Here, we demonstrate patterns of pulmonary vascular disease in COVID‐19 including classical acute pulmonary embolism and subsegmental perfusion defects in the absence of acute pulmonary embolism suggestive of microvascular thrombosis.
Critical observations of the International Prostate Symptoms Score questionnaire and proposal for amendments to simplify and improve its quality: A review
Authors: Aminu Sani 
Published: November 2020

The International Prostate Symptoms Score (IPSS) is an important tool for evaluation and research in benign prostatic hyperplasia related lower urinary tract symptoms in men. It has also been validated in many languages. This article discusses issues observed in the symptoms domains, as well as issues related to the intensity of the numeracy in the scoring parameters. The objectives of this article are to analyse what could be improved on the IPSS questionnaire and to discuss a proposal for amendments. Such amendments include putting nocturia as the first question, modifying other questions, allowing maximum subjectivity for the patient, modifying the scoring system to reduce intense numeracy for the patient and adding a new section on fluid intake and medication. This would hopefully simplify the questionnaire for patients, improve its quality as well as improve communication between patients, family physicians and urologists. Level of evidence: Not applicable for this multicentre audit.
Creating a toolkit with stakeholders for leveraging tablet computers to support person-centred dementia care in hospitals
Authors: Shadarevian John , Chan Cheryl , Berndt Annette , Son Cathy , Gregorio Mario , Horne Neil , Mann Jim , Wallsworth Christine , Chow Bryan , O’Neill Ryan , Hung Lillian 
Published: November 2020

Introduction People with dementia may refuse care because they feel overwhelmed by an unfamiliar environment. Everyday technology such as tablets have the potential to support person-centred dementia care in hospitals. Aims We aimed to identify barriers and enabling factors in order to develop a toolkit to support the use of tablets in engaging individual and group activities, especially to play family videos, for hospitalized older people with dementia. Methods A participatory action research approach was employed. We facilitated staff focus groups and conducted interviews with stakeholders. A toolkit was developed based on participants’ perspectives on how to support successful adoption. Results Our analysis identified two enabling factors: users’ engagement in developing a toolkit for support and adapting implementation to meet local needs. Barriers included staff and family inexperience, mechanical instability of hardware, issues around privacy and data access, technology use and personalization of messages. The toolkit includes short videos, a brochure for family caregivers, and a pocket card for staff. Discussion and implications: Staff, family and patients start with varying levels of experience with the use of tablets, making education and support vitally important to implementation. Health organizations should involve staff, patients, and families to find practical solutions.