Feasibility assessment

  • 文章类型: Journal Article
    从各种清洁能源发电技术中,浮动太阳能光伏已成为全球高度可持续和环保的解决方案。然而,由于对水体的可用性和合适的气候条件的重要考虑,浮动太阳能的安装不同于屋顶或地面安装太阳能。因此,对合适的气候进行可行性分析对于在水体上安装浮动太阳能发电厂至关重要。对这些数据进行了评估,以评估在达卡的Hatirjheel湖上安装6.7MW浮式太阳能发电厂的可行性,孟加拉国。可行性分析结合了各种气候数据,如温度,湿度,湿度降雨,日照时数,太阳辐射,和风速,从Meteonorm8.1软件和孟加拉国气象部门的档案中获得。此外,这项研究收集并分析了达卡配电公司运营的当地电网变电站的能源需求,以确定发电厂的适当容量和架构。电厂设计使用PVsyst7.3软件进行,确定了必要的设备数量,直流发电容量,以及以MWh为单位注入电网的能量。该研究还计算了每千瓦时的能源均衡成本和系统的投资回收期,这表明了安装该系统的经济可行性。此外,获得的数据集具有巨大的潜力,可用于建立各种太阳能发电厂,包括浮动太阳能发电厂,在达卡都市区内的任何位置或水体中。
    Floating solar photovoltaic has emerged as a highly sustainable and environmentally friendly solution worldwide from the various clean energy generation technologies. However, the installation of floating solar differs from rooftop or ground-mounted solar due to the significant consideration of the availability of water bodies and suitable climatic conditions. Therefore, conducting a feasibility analysis of the suitable climate is essential for installing a floating solar plant on water bodies. These data are evaluated for the viability of installing a 6.7 MW floating solar power plant on Hatirjheel Lake in Dhaka, Bangladesh. The feasibility analysis incorporated various climatic data, such as temperature, humidity, rainfall, sunshine hours, solar radiation, and windspeed, obtained from Meteonorm 8.1 software and the archive of the Bangladesh Meteorological Department. Besides, this study gathered and analyzed the energy demands of the local grid substation operated by Dhaka Power Distribution Company, to determine the appropriate capacity and architecture of the power plant. The power plant design was conducted using the PVsyst 7.3 software, which determined the necessary equipment quantities, DC energy generation capacity, and the energy injected into the grid in MWh. The study also calculated the Levelized Cost of Energy per kilowatt-hour and the payback period for the system, which indicates the economic viability of installing the system. Furthermore, the acquired dataset possesses significant potential and can be utilized for the establishment of all sorts of solar power plants, including floating solar plants, in any location or body of water within the Dhaka Metropolitan area.
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  • 文章类型: Journal Article
    很少有面向患者或公众的工具来进行纵向和全面的症状评估,特别是当面临未明确特征的疾病,如COVID-19或症状未得到充分明确的慢性疾病时。为了满足这一需求,我们开发了症状发现移动应用程序,并在COVID-19大流行早期向美国公众测试了其可行性。虽然有挑战,结果证明了可行性和验收性。
    There are few patient- or public-facing tools for longitudinal and comprehensive symptom assessment, especially when faced with an uncharacterized condition such as COVID-19 or a chronic condition in which symptoms have not been adequately specified. To address this need, we developed the Symptom Discovery mobile application and tested its feasibility with the US public early in the COVID-19 pandemic. Although there were challenges, results showed feasibility and acceptance.
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  • 文章类型: Journal Article
    建筑能耗的不断增加,固体废物种类和数量的增加严重阻碍了社会经济的快速发展。因此,降低建筑能耗,同时实现废弃物的资源化,已成为新时期环保建设的主流话题。以EPS颗粒为轻质骨料,制备了用于建筑墙体的碱活化超轻泡沫保温材料(AFIM)。EPS用量的影响,颗粒大小,和抗压强度的级配,干密度,热导率,研究了AFIM的体积吸水率。结果表明,在保证AFIM良好力学性能的同时,EPS颗粒可以显著降低干密度,热导率,和AFIM的体积吸水率。令人兴奋的是,AFIM的最佳热导率和干密度分别为0.0408W/(m·K)和127.03kg/m3。微观形貌结果表明,EPS颗粒与AFIM浆料具有良好的相容性,它们之间的界面过渡区(ITZ)致密,没有明显的裂缝。此外,从四个方面对AFIM的可行性进行了评估:性能,能源消耗,碳排放,和生命周期成本(LCC)。令人欣慰的是,AFIM的性能与传统隔热材料的性能相当,在节能方面表现出显著优势,与传统胰岛素材料相比,减排量和经济效益。
    The continuous increase in building energy consumption, and the increasing types and quantities of solid waste have seriously hindered the rapid development of social economy. Therefore, reducing building energy consumption while realizing the recycling of waste has become the mainstream topic of environmental protection construction in the new era. An alkali-activated ultra-light foamed insulation material (AFIM) for building walls was prepared using EPS particles as lightweight aggregates. The effects of EPS dosage, particle size, and gradation on the compressive strength, dry density, thermal conductivity, and volumetric water absorption of AFIM were studied. The results showed that while ensuring good mechanical properties of AFIM, EPS particles can significantly reduce the dry density, thermal conductivity, and volumetric water absorption of AFIM. Excitingly, the optimal thermal conductivity and dry density of AFIM were 0.0408 W/(m·K) and 127.03 kg/m3, respectively. The microscopic morphology results showed that there was good compatibility between EPS particles and AFIM slurry, and the interface transition zone (ITZ) between them was dense and without obvious cracks. In addition, the feasibility of AFIM was evaluated from four aspects: performance, energy consumption, carbon emissions, and life cycle cost (LCC). It was encouraged that the performance of AFIM was comparable to that of traditional insulation materials, and showed significant advantages in energy conservation, emission reduction and economic benefits compared to traditional insulatin materials.
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  • 文章类型: Journal Article
    背景:现实世界数据(RWD)越来越多地用于生成用于监管目的的疫苗安全性和有效性的现实世界证据(RWE)。建议在实施观察性研究之前评估使用RWD源的可行性。作为一个用例,我们描述了可行性评估的过程和结果,以确定可靠和相关的数据源,用于监测中国AS04-HPV-16/18人乳头瘤病毒(HPV)疫苗的安全性和有效性.
    方法:迭代多步骤过程:(1)有针对性的文献回顾和数据源映射;(2)来自国家RWD专家的专家意见;(3)调查以评估已识别的数据源操作基础设施;(4)使用已识别的数据源对已发表的研究进行持续评估。
    结果:鄞州区域卫生信息平台(YRHIP)被确定为主要关注的数据源,基于其庞大的人口覆盖率,宫颈癌筛查率高,以及成人电子免疫记录的可用性。与国家RWD专家的实地会议证实了其对授权后疫苗研究的适用性。调查结果显示,暴露数据以及相关的安全性和有效性终点在整个平台上被记录和链接。对文献中新兴证据的迭代评估证实了这些发现。
    结论:此可行性评估表明,YRHIP具有捕获人口统计的能力,暴露,结果和生成中国HPV疫苗安全性和有效性RWE所需的其他数据。使用YRHIP监测AS04-HPV-16/18疫苗常规使用的研究正在进行中,建立在这种可行性评估的基础上。本文受版权保护。保留所有权利。
    Real-world data (RWD) are increasingly used to generate real-world evidence (RWE) of vaccine safety and effectiveness for regulatory purposes. Assessing feasibility of using RWD sources prior to implementing observational studies is recommended. As a use case, we described the process and findings of a feasibility assessment to identify reliable and relevant data sources for monitoring the safety and effectiveness of the AS04-HPV-16/18 human papillomavirus (HPV) vaccine in China.
    Iterative multi-step process: (1) targeted literature review and data source mapping; (2) expert opinion from national RWD experts; (3) survey to evaluate the identified data source operational infrastructure; and (4) continuous appraisal of published studies using the identified data source.
    The Yinzhou Regional Health Information Platform (YRHIP) was identified as a data source of main interest, based on its large population coverage, high cervical cancer screening rates, and availability of adult electronic immunization records. Field meetings with national RWD experts confirmed its suitability for post-authorization vaccine studies. Survey results showed that exposure data and relevant safety and effectiveness endpoints were recorded and linkable at the individual level across the platform. Iterative appraisal of emerging evidence from the literature corroborated these findings.
    This feasibility assessment indicates that the YRHIP has the capacity to capture demographic, exposure, outcome and other data required to generate RWE on HPV vaccine safety and effectiveness in China. Studies using the YRHIP to monitor the AS04-HPV-16/18 vaccine in routine use building on this feasibility assessment are ongoing.
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  • 文章类型: Journal Article
    HOME(家庭监测和教育)项目的可行性阶段旨在展示使用患者控制的移动系统进行脑电图(EEG)家庭监测的实际可行性。其目的是评估与传统医疗保健相比,家庭监控的潜在诊断和治疗效果。
    16位办公室从业者选择了97位患者,并使用常规记录仪记录了标准的20分钟脑电图。培训后,相同患者在其家庭环境中使用了患者控制的移动干电极EEG系统.负责的从业者和另外两名评估者评估了所有录音。我们在诊断结果之间进行了评估者之间和评估者之间的比较。
    89名患者成功进行了家庭监测记录。常规记录和患者记录的诊断结果的评分者内部比较结果显示Cohen的kappa值(0.21)相当。此外,我们记录了9例患者管理的变化.
    确认了使用患者控制设备进行EEG家庭监测的可行性。EEG家庭监测的产量包括可以影响患者管理的信息。
    患者控制脑电图家庭监测作为神经科门诊患者常规护理的一部分是可行的,因为它的技术功效和实际可行性得到了证明,并且对患者管理产生了显著的积极影响。
    The feasibility phase of the HOME (Home-Monitoing and Education) project aims to show the practical feasibility of Electroencephalography (EEG)home-monitoring using a patient-controlled mobile system. Its objective is to assess the potential diagnostic and therapeutic yields of home-monitoring compared to conventional healthcare.
    16 office-based practitioners chose 97 patients and recorded standard 20-minute EEGs using conventional recorders. After training, the same patients used a patient-controlled mobile dry electrode EEG system in their home environment. The practitioners in charge and two additional raters assessed all recordings. We conducted inter-rater and intra-rater comparisons between the diagnostic findings.
    89 patients successfully conducted home-monitoring recordings. The intra-rater comparison results for the diagnostic findings of the conventional recordings and the patient-made recordings show a fair Cohen\'s kappa value (0.21). Additionally, we documented a change of patient management in 9 cases.
    The feasibility of EEG home-monitoring using a patient-controlled device is confirmed. The yield of EEG home-monitoring comprises information that can influence patient management.
    Patient-controlled EEG home-monitoring is feasible as part of routine care for neurological outpatients as its technical efficacy and practical feasibility are shown and significantly positive effects on patient management are evidenced.
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  • 文章类型: Journal Article
    是否有足够的能力和能力来成功进行和交付临床试验应由几个利益相关者在试验计划期间根据透明和基于证据的标准进行评估。对于这个公开分享的,经过用户测试,和验证的工具是必要的。因此,我们系统地检查了在临床试验计划阶段评估研究水平可行性的清单的公开可用性和内容.
    在我们的范围审查中,我们系统地搜索了Medline,EMBASE,和谷歌(最后一次搜索,2021年6月)。我们包括所有公开可用的检查表或评估临床试验研究水平可行性的工具,检查他们的内容,并检查它们是否经过用户测试或以任何形式验证。使用常规内容分析对数据进行分析和综合。
    共确定了来自五个国家的10份公开清单。清单包括48个不同的项目,根据以下七个不同的临床试验可行性领域进行分类:审查和监督;参与者招募;空间,材料和设备;财务资源;试验团队资源;试验管理;以及试点或可行性研究。所有可用的清单似乎都没有经过用户测试或验证。
    虽然有许多公开的评估临床试验可行性的检查表,其可靠性和有用性仍不清楚。公开分享,经过用户测试,缺乏用于更好地规划临床试验的经过验证的可行性评估工具。
    Whether there is sufficient capacity and capability for the successful conduct and delivery of a clinical trial should be assessed by several stakeholders according to transparent and evidence-based criteria during trial planning. For this openly shared, user-tested, and validated tools are necessary. Therefore, we systematically examined the public availability and content of checklists which assess the study-level feasibility in the planning phase of clinical trials.
    In our scoping review we systematically searched Medline, EMBASE, and Google (last search, June 2021). We included all publicly available checklists or tools that assessed study level feasibility of clinical trials, examined their content, and checked whether they were user-tested or validated in any form. Data was analysed and synthesised using conventional content analysis.
    A total of 10 publicly available checklists from five countries were identified. The checklists included 48 distinct items that were classified according to the following seven different domains of clinical trial feasibility: regulation, review and oversight; participant recruitment; space, material and equipment; financial resources; trial team resources; trial management; and pilot or feasibility studies. None of the available checklists appeared to be user-tested or validated.
    Although a number of publicly available checklists to assess the feasibility of clinical trials exist, their reliability and usefulness remain unclear. Openly shared, user-tested, and validated feasibility assessment tools for a better planning of clinical trials are lacking.
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  • 文章类型: Journal Article
    临床路径(CP)是用于有效管理护理过程的工具。在过程挖掘领域中,有几项关于开发临床路径(CPs)的研究工作。然而,数据的性质影响数据分析结果,和患者的临床变异性使得发展CP具有挑战性。因此,在应用过程挖掘技术之前,确定可以标准化为CP的候选护理过程至关重要。本文提出了一种使用电子健康记录中的临床订单日志评估临床复杂性的CP可行性的方法。所提出的方法包括数据准备,活动和痕迹同质性评估,和使用过程挖掘的过程检查。每个步骤都包括用于衡量流程同质性的指标和基于日志演示流程多样性的可视化方法。该案例研究是对韩国一家三级医院的五个手术组患者进行的,以验证所提出的方法。对5组患者进行成功评估。此外,可视化方法帮助临床专家掌握护理过程的多样性。
    A clinical pathway (CP) is a tool for effectively managing a care process. There are several research efforts on developing clinical pathways (CPs) in the process mining domain. However, the nature of the data affects data analysis results, and patient clinical variability makes it challenging to develop CPs. Thus, it is crucial to determine candidate care processes that can be standardized as CPs before applying process mining techniques. This paper proposed a method for assessing CP feasibility regarding clinical complexity using clinical order logs from electronic health records. The proposed method consists of data preparation, activity & trace homogeneity evaluations, and process inspection using process mining. Each step consists of metrics to measure the homogeneity of processes and a visualization method to demonstrate the diversity of processes based on the log. The case study was conducted with five surgical groups of patients from a tertiary hospital in South Korea to validate the proposed method. The five groups of patients were successfully assessed. In addition, the visualization methods helped clinical experts grasp the diversity of care processes.
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  • 文章类型: Comparative Study
    缺乏在多发性硬化症(MS)患者中比较西波莫德与芬戈莫德或奥法单抗的头对头试验。相反,西波莫德的疗效比较可以来自间接治疗比较(ITC).我们评估了ITC利用来自不同MS表型的相关III期试验的个体患者数据的适用性。
    一项针对继发性进展型MS(SPMS)患者的西波莫德试验,四项芬戈莫德试验(三项复发缓解型MS[RRMS],和一个在初级渐进式MS[PPMS]中),并考虑了两项针对复发性MS(RMS)的ofatumumab试验。ITC的适用性是根据试验设计进行评估的,患者资格标准,基线患者特征,安慰剂反应,和每个试验的结果定义。认为可行的分析使用一对一倾向评分匹配(PSM)进行。
    由于关键患者特征(例如残疾水平和复发史)的重叠不足以及安慰剂反应的差异,SPMS中的西波莫德与RRMS中的芬戈莫德或RMS中的奥伐木单抗之间的ITC不可行。然而,SPMS中的辛波莫德和PPMS中的芬戈莫德的比较是可行的,因为在资格标准和基线特征方面有足够的重叠.一对一PSM表明,西波莫德相对于芬戈莫德在6个月和3个月确认的残疾进展中受到青睐,尽管没有显着差异(风险比0.76[95%置信区间0.48-1.20;p值=.240]和风险比0.80[95%置信区间0.52-1.22;p值=.300],分别)。
    对于MS中的试验,临床表型是ITC可行性的重要决定因素。SPMS中的辛波莫德与RRMS中的芬戈莫德或RMS中的奥法单抗之间的ITC是不可行的。唯一可行的比较是在SPMS中的辛波莫德和PPMS中的芬戈莫德之间。
    Head-to-head trials comparing siponimod with fingolimod or ofatumumab in patients with multiple sclerosis (MS) are lacking. Instead, the comparative efficacy of siponimod can be derived from indirect treatment comparisons (ITCs). We assessed the suitability of ITCs leveraging individual patient data from relevant phase III trials across different MS phenotypes.
    One siponimod trial in patients with secondary progressive MS (SPMS), four fingolimod trials (three in relapsing-remitting MS [RRMS], and one in primary progressive MS [PPMS]), and two ofatumumab trials in relapsing MS (RMS) were considered. The suitability of ITCs was evaluated based on trial design, patient eligibility criteria, baseline patient characteristics, placebo response, and outcome definitions for each trial. Analyses deemed feasible were conducted using one-to-one propensity score matching (PSM).
    An ITC between siponimod in SPMS and either fingolimod in RRMS or ofatumumab in RMS was not feasible because of insufficient overlap in key patient characteristics (e.g. disability level and relapse history) and differences in placebo response. However, a comparison between siponimod in SPMS and fingolimod in PPMS was feasible because of sufficient overlap in eligibility criteria and baseline characteristics. One-to-one PSM demonstrated siponimod was favored relative to fingolimod for time to 6- and 3-month confirmed disability progression though not significantly different (hazard ratio 0.76 [95% confidence interval 0.48-1.20; p-value = .240] and hazard ratio 0.80 [95% confidence interval 0.52-1.22; p-value = .300], respectively).
    For trials in MS, clinical phenotype is an important determinant of ITC feasibility. An ITC between siponimod in SPMS and either fingolimod in RRMS or ofatumumab in RMS was not feasible. The only feasible comparison was between siponimod in SPMS and fingolimod in PPMS.
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  • 文章类型: Journal Article
    Data collected in real-world clinical settings are increasingly being used to evaluate therapeutic options. While in its infancy for research assessing effectiveness, especially comparative effectiveness in the regulatory environment, electronic health records (EHR) and administrative insurance claims data are used extensively by both manufacturers and regulators to evaluate post-marketing safety of products in the real world. The feasibility of using these data for analysis in a research study depends on the specific research question and the availability, quality and relevance of the collected data to address the scientific question. It is unlikely that any specific database could be \'qualified\' for use across all research questions, even within a specific therapeutic area, due to dependence of feasibility on the elements of the specific research question. This paper describes considerations for determining whether EHR or claims data can be used for specific research purposes. A new structured approach for assessing the feasibility of these data in research is proposed. The framework builds on and considers whether each element of the PICOTS framework for well-structured research questions is adequately captured to allow for viable reliance on EHR and claims data for that specific scientific question. Practical examples and discussion of the limitations of RWD for research are given along with approaches for interpretation of analyses using RWD.
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  • 文章类型: Evaluation Study
    BACKGROUND: Sierra Leone, a fragile country, is facing an increasingly significant burden of non-communicable diseases (NCDs). Facilitated by an international partnership, a project was developed to adapt and pilot desktop guidelines and other clinical support tools to strengthen primary care-based hypertension and diabetes diagnosis and management in Bombali district, Sierra Leone between 2018 and 2019. This study assesses the feasibility of the project through analysis of the processes of intervention adaptation and development, delivery of training and implementation of a care improvement package and preliminary outcomes of the intervention.
    METHODS: A mixed-method approach was used for the assessment, including 51 semi-structured interviews, review of routine treatment cards (retrieved for newly registered hypertensive and diabetic patients from June 2018 to March 2019 followed up for three months) and mentoring data, and observation of training. Thematic analysis was used for qualitative data and descriptive trend analysis and t-test was used for quantitative data, wherever appropriate.
    RESULTS: A Technical Working Group, established at district and national level, helped to adapt and develop the context-specific desktop guidelines for clinical management and lifestyle interventions and associated training curriculum and modules for community health officers (CHOs). Following a four-day training of CHOs, focusing on communication skills, diagnosis and management of hypertension and diabetes, and thanks to a CHO-based mentorship strategy, there was observed improvement of NCD knowledge and care processes regarding diagnosis, treatment, lifestyle education and follow up. The intervention significantly improved the average diastolic blood pressure of hypertensive patients (n = 50) three months into treatment (98 mmHg at baseline vs. 86 mmHg in Month 3, P = 0.001). However, health systems barriers typical of fragile settings, such as cost of transport and medication for patients and lack of supply of medications and treatment equipment in facilities, hindered the optimal delivery of care for hypertensive and diabetic patients.
    CONCLUSIONS: Our study suggests the potential feasibility of this approach to strengthening primary care delivery of NCDs in fragile contexts. However, the approach needs to be built into routine supervision and pre-service training to be sustained. Key barriers in the health system and at community level also need to be addressed.
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