Pilot study

试点研究
  • 文章类型: Journal Article
    Thermophilic anaerobic digestion (AD) offers many benefits for food waste treatment but is seldom adopted in industrial plants due to instability issue, particularly under higher loading conditions. This study thus conducted a 160-day continuous operation of a pilot-scale thermophilic AD system on-site. Results from the experiments showed that the system could operate under relatively lower loading but failed when the loading reached up to 5.69 kg·COD/(m3·d). Volatile fatty acids increased to 6000 mg/L at the corresponding hydraulic retention time of 15 days. Trace elements were then introduced, which restored higher process stability by reducing volatile fatty acids to 400 mg/L. The mass balance and materials decomposition resutls revealed the system\'s strong resilience. Methanoculleus (92.52 %) and Methanomassiliicoccus (6.55 %) were the dominant methanogens, a phenomenon rarely observed in similar thermophilic systems. This system may tolerate more stressful conditions, as the loading limits had not been reached with the addition of trace elements.
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  • 文章类型: Journal Article
    The Bergen Four Day Treatment (B4DT) is a concentrated treatment for OCD that has demonstrated promising effectiveness in Nordic country samples. The B4DT is delivered over four days and provides individual treatment in a group context. The effectiveness of the B4DT for OCD has not been tested outside Nordic countries. The current pilot study evaluated the feasibility and the potential effectiveness of B4DT in a different culture and health-care system in the United States. Findings from 48 adults with OCD who completed the B4DT indicated that OCD, anxiety, and depression symptom severity significantly decreased from pre- to post-treatment, and gains were maintained at six month follow-up. The Yale-Brown Obsessive Compulsive Scale scores were reduced from moderate to subclinical; specifically, the average scores of 27.0 (pre-treatment) fell to 11.7 (post-treatment), 12.7 (3-month follow-up), and 13.7 (6-month follow-up). The B4DT was rated as highly acceptable by the US patients. Over 95% of the patients stated that they would recommend the treatment to a friend. These findings provide the first preliminary evidence for the generalizability of the B4DT to patients outside Nordic countries. Cultural and context-dependent issues that affected this dissemination pilot study are discussed in addition to future clinical and research directions.
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  • 文章类型: Journal Article
    背景:自杀是美国第12大死亡原因。医疗保健提供者培训是国家预防自杀行动联盟确定的首要研究重点;然而,基于证据的方法,目标技能建设是资源密集型的,难以实施。利用人工智能的新型计算机技术现在已经可用,这有望增加在一系列继续教育环境中提供学员机会的可行性,以参与技能实践,并对绩效进行建设性反馈。
    目的:这项初步研究旨在评估在美国1级创伤中心接受急性或重症监护的患者中进行自杀安全计划电子学习培训的可行性和可接受性。培训包括有示范的说教部分,与基于网络的虚拟患者(客户端机器人艾米丽)的微咨询技能的实践,与耐心演员的角色扮演,并通过基于Web的平台(LysnAdvisor)根据角色扮演对一般咨询技能进行自动编码和反馈。其次,我们检查了知识的学习成果,信心,以及描述自杀安全计划的技能。
    方法:在2021年11月1日至2022年5月31日之间招募了急性和重症监护护士,以参加使用预培训的形成性评估,培训后,和6个月的跟踪调查,以及观察护士通过标准化患者角色扮演在6个月内实施自杀安全计划的表现,并使用安全计划干预评定量表进行评分。护士在与客户机器人艾米丽互动并通过LyssnAdvisor根据他们的角色扮演审查一般咨询得分后,完成了系统可用性量表。
    结果:共有18名护士参与了这项研究,其中大部分为女性(n=17,94%)和白人(n=13,72%)。在开始培训的17名护士中,82%(n=14)完成了它。平均而言,客户端BotEmily的系统可用性量表得分为70.3分(SD19.7分),LyssnAdvisor的系统可用性量表得分为65.4分(SD16.3分).平均而言,培训后护士认可了良好的知识(平均3.1,SD0.5)和信心(平均2.9,SD0.5).完成培训后,没有任何护士在安全计划干预评定量表(≥14)上的熟练程度得分高于专家得出的界限;然而,平均而言,根据LyssnAdvisor,护士的一般咨询技能高于临界值(同理心:平均4.1,SD0.6;协作:平均3.6,SD0.7).
    结论:研究结果表明,在这种情况下完成培训活动和使用新技术是可行的。技术修改可以提高培训的可接受性和实用性,例如,增加虚拟患者对话能力,并为特定的自杀安全计划技能增加自动编码能力。
    RR2-10.2196/33695。
    BACKGROUND: Suicide is the 12th leading cause of death in the United States. Health care provider training is a top research priority identified by the National Action Alliance for Suicide Prevention; however, evidence-based approaches that target skill building are resource intensive and difficult to implement. Novel computer technologies harnessing artificial intelligence are now available, which hold promise for increasing the feasibility of providing trainees opportunities across a range of continuing education contexts to engage in skills practice with constructive feedback on performance.
    OBJECTIVE: This pilot study aims to evaluate the feasibility and acceptability of an eLearning training in suicide safety planning among nurses serving patients admitted to a US level 1 trauma center for acute or intensive care. The training included a didactic portion with demonstration, practice of microcounseling skills with a web-based virtual patient (Client Bot Emily), role-play with a patient actor, and automated coding and feedback on general counseling skills based on the role-play via a web-based platform (Lyssn Advisor). Secondarily, we examined learning outcomes of knowledge, confidence, and skills in suicide safety planning descriptively.
    METHODS: Acute and intensive care nurses were recruited between November 1, 2021, and May 31, 2022, to participate in a formative evaluation using pretraining, posttraining, and 6-month follow-up surveys, as well as observation of the nurses\' performance in delivering suicide safety planning via standardized patient role-plays over 6 months and rated using the Safety Plan Intervention Rating Scale. Nurses completed the System Usability Scale after interacting with Client Bot Emily and reviewing general counseling scores based on their role-play via Lyssn Advisor.
    RESULTS: A total of 18 nurses participated in the study; the majority identified as female (n=17, 94%) and White (n=13, 72%). Of the 17 nurses who started the training, 82% (n=14) completed it. On average, the System Usability Scale score for Client Bot Emily was 70.3 (SD 19.7) and for Lyssn Advisor was 65.4 (SD 16.3). On average, nurses endorsed a good bit of knowledge (mean 3.1, SD 0.5) and confidence (mean 2.9, SD 0.5) after the training. After completing the training, none of the nurses scored above the expert-derived cutoff for proficiency on the Safety Plan Intervention Rating Scale (≥14); however, on average, nurses were above the cutoffs for general counseling skills per Lyssn Advisor (empathy: mean 4.1, SD 0.6; collaboration: mean 3.6, SD 0.7).
    CONCLUSIONS: Findings suggest the completion of the training activities and use of novel technologies within this context are feasible. Technologic modifications may enhance the training acceptability and utility, such as increasing the virtual patient conversational abilities and adding automated coding capability for specific suicide safety planning skills.
    UNASSIGNED: RR2-10.2196/33695.
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  • 文章类型: Clinical Study
    背景:老年人的低体力活动与抑郁和孤独等不良健康结果有关,身体机能差,跌倒风险增加。这项研究旨在通过数字技术增加身体活动,基于群体,体育活动和音乐干预,并检查其对社会的有效性,精神和身体健康的结果。
    方法:参与者是在苏格兰的四个护理院招募的34名老年人(65岁以上)进行试点研究。在基线和干预后进行调查,包括害怕跌倒的措施,抑郁和焦虑,孤独,睡眠满意度和生活质量。在每个时间点还进行了一系列的身体功能测试和唾液采样以进行皮质醇和脱氢表雄酮激素分析。此外,过程评估措施(招聘,干预保真度,出席,保留率和安全性)进行监测。干预包括12周,每周三次规定的数字会议:运动和音乐(n=2)和仅音乐(n=1)。由养老院的活动协调员交付。对工作人员和参与者进行了干预后访谈,以获得有关干预措施可接受性的定性数据。
    结果:平均88%的规定疗程完成。所有参与者的干预前后意向治疗分析显示,焦虑有显著改善,唾液DHEA,害怕跌倒和孤独。与健康相关的生活质量没有显着改善,感知压力,睡眠满意度或身体功能测试,包括握力。定性分析强调了该计划的好处和障碍。
    结论:数字运动和音乐干预被认为是可以接受的,并且具有中等的保真度。证明进展为全面试验是合理的。尽管适当的对照组会产生更有信心的因果关系,初步的社会心理和生物学效应在本试验中很明显.为了显示身体机能的显著改善,很可能更大的样本量提供足够的能力来检测重大变化,更大的坚持,可能需要更长的干预和/或更高的运动量。
    背景:该试验已在ClinicalTrials.gov注册,编号NCT05601102在01/11/2022。
    BACKGROUND: Low physical activity among older adults is related to adverse health outcomes such as depression and loneliness, poor physical function and increased risk of falls. This study was designed to increase physical activity through a digital, group-based, physical activity and music intervention and to examine its effectiveness on social, mental and physical health outcomes.
    METHODS: Participants were 34 older adults (65 years +) recruited across four care homes in Scotland to a pilot study. Surveys were administered at baseline and post-intervention, comprising measures of fear of falling, depression and anxiety, loneliness, sleep satisfaction and quality of life. A battery of physical function tests and saliva sampling for cortisol and dehydroepiandrosterone hormone analysis were also conducted at each time point. Additionally, process evaluation measures (recruitment, intervention fidelity, attendance, retention rates and safety) were monitored. The intervention comprised 12 weeks of three prescribed digital sessions per week: movement and music (n = 2) and music-only (n = 1), delivered by an activity coordinator in the care home. Post-intervention interviews with staff and participants were conducted to gain qualitative data on the acceptability of the intervention.
    RESULTS: An average of 88% of prescribed sessions were delivered. Pre- to post-intervention intention-to-treat analysis across all participants revealed significant improvements in anxiety, salivary DHEA, fear of falling and loneliness. There were no significant improvements in health-related quality of life, perceived stress, sleep satisfaction or physical function tests, including handgrip strength. Qualitative analysis highlighted benefits of and barriers to the programme.
    CONCLUSIONS: The digital movement and music intervention was deemed acceptable and delivered with moderate fidelity, justifying progression to a full-scale trial. Although a proper control group would have yielded more confident causal relationships, preliminary psychosocial and biological effects were evident from this trial. To show significant improvements in physical function, it is likely that a bigger sample size providing sufficient power to detect significant changes, greater adherence, longer intervention and/or higher exercise volume may be necessary.
    BACKGROUND: The trial is registered at ClinicalTrials.gov, number NCT05601102 on 01/11/2022.
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  • 文章类型: Editorial
    试点试验的科学正在发展,人们对它们在医学研究中的作用越来越了解。围手术期随机对照试验通常测试固有的多学科和复杂的干预措施;因此,可能有令人信服的理由进行试点研究,以评估可行性并为试验设计提供信息。由于试点研究本身需要资源,研究者不应该浪费这个机会;他们应该设计这些机会,以便他们正确地解决关于最终试验成功的不确定性来源.
    The science of pilot trials is evolving, and understanding of their role in medical research is increasing. Perioperative randomised controlled trials often test interventions that are inherently multidisciplinary and complex; therefore, there might be compelling reasons to conduct pilot studies to assess feasibility and inform trial design. As pilot studies themselves require resources, investigators should not squander this opportunity; they should design them so that they properly address the sources of uncertainty regarding the success of the definitive trial.
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  • 文章类型: Journal Article
    背景:技术在教学中的整合提供了高效和多样化的学习机会。研究表明,使用虚拟现实(VR),提高解剖学知识和空间理解。这项试点研究的目的是检查是否使用沉浸式虚拟现实护目镜作为解剖学学习工具增加助产学生的知识,探索VR替代传统课堂教学的潜力。
    方法:我们在两个高等教育助产学生队列中使用VR作为学习工具之前和之后的问卷调查进行了预试点研究。队列1在参加VR课程之前已经完成了八个小时的解剖学课堂教学。
    结果:该研究包括来自挪威一所大学的助产学硕士课程的两个不同班级的44名助产学学生。这两个队列的学生都在他们的助产研究的第一学期,并拥有护理学士学位。两个队列在参加VR学习课程后立即和14天的解剖学知识平均得分均增加。没有参加解剖学讲座的学生在知识上得分很高,在VR会话之前和之后,与在解剖学中进行额外课堂教学的队列相比。
    结论:将VR作为一种学习工具,可以有助于增加空间理解和解剖学知识。通过关注学生学习与学习活动和协作相结合,这项技术帮助学生获得理解和知识。
    BACKGROUND: The integration of technology within teaching offers efficient and diverse learning opportunities. Studies have shown that the use of virtual reality (VR), improves anatomical knowledge and spatial understanding. The aim of this pilot study was to examine whether the utilization of immersive virtual reality goggles as a learning tool for anatomy increase midwifery students\' knowledge, and to explore the potential of replacing traditional classroom teaching with VR.
    METHODS: We conducted a pre-post pilot study using a questionnaire before and after the use of VR as a learning tool in two cohorts of midwifery students in higher education. Cohort one had completed eight hours of classroom teaching of anatomy before participating in the VR session.
    RESULTS: The study included 44 midwifery students from two different classes at the same Master\'s program in midwifery at a university college in Norway. Student in both cohorts were in their first semester of midwifery studies and possessed a Bachelor\'s degree in nursing. Both cohorts had an increased average mean score in anatomical knowledge immediate after and 14 days after attending the learning session in VR. Students from the cohort that did not participate in anatomy lectures scored high on knowledge, both before and after the session in VR compared to the cohort that had additional classroom teaching in anatomy.
    CONCLUSIONS: Implementing VR as a learning tool, can contribute to increase spatial understanding and anatomical knowledge. By focusing on student learning in combination with learning activities and collaboration, the technology helps students gain understanding and knowledge.
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  • 文章类型: Journal Article
    背景:技术已准备好弥合对改善帕金森氏症患者步态的治疗需求与可用资源之间的差距。可穿戴传感器,Heel2Toe™,一个小装置,附着在鞋子的侧面,每次人开始他们的脚步时都会发出声音,是由麦吉尔大学的一个团队开发和预先测试的。这项研究的目的是评估Heel2Toe™传感器在改变帕金森氏症患者步行能力和步态模式方面的可行性和功效潜力。
    方法:进行了一项试点研究,涉及27名随机2:1的帕金森氏症患者,使用Heel2Toe[TM]传感器进行训练,或使用步态相关工作簿中的建议进行训练。
    结果:共有21人完成了为期3个月的评估,14用Heel2Toe[TM]传感器训练,和7训练与工作簿。Heel2Toe组的14人中有13人改善了主要结果的测量误差,6分钟步行测试,(平均变化66.4m)和工作簿组中7个中的0个(平均变化-19.4m):Heel2Toe组中14个中的4个做出了可靠的变化,而工作簿组中7个中的0个做出了可靠的变化。步行距离的改善伴随着步态质量的改善。干预组40%的参与者对他们的技术经验非常满意,另有37%的参与者感到满意。
    结论:尽管存在一些技术困难,支持Heel2Toe传感器改善帕金森病患者步态的可行性和功效潜力。
    BACKGROUND: Technology is poised to bridge the gap between demand for therapies to improve gait in people with Parkinson\'s and available resources. A wearable sensor, Heel2Toe™, a small device that attaches to the side of the shoe and gives a sound each time the person starts their step with a strong heel strike, has been developed and pre-tested by a team at McGill University. The objective of this study was to estimate feasibility and efficacy potential of the Heel2Toe™ sensor in changing walking capacity and gait pattern in people with Parkinson\'s.
    METHODS: A pilot study was carried out involving 27 people with Parkinson\'s randomized 2:1 to train with the Heel2Toe[TM] sensor and or to train with recommendations from a gait-related workbook.
    RESULTS: A total of 21 completed the 3-month evaluation, 14 trained with the Heel2Toe[TM] sensor, and 7 trained with the workbook. Thirteen of 14 people in the Heel2Toe group improved over measurement error on the primary outcome, the 6-Minute Walk Test, (mean change 66.4 m) and 0 of the 7 in the Workbook group (mean change - 19.4 m): 4 of 14 in the Heel2Toe group made reliable change and 0 of 7 in the Workbook group. Improvements in walking distance were accompanied by improvements in gait quality. Forty percent of participants in the intervention group were strongly satisfied with their technology experience and an additional 37% were satisfied.
    CONCLUSIONS: Despite some technological difficulties, feasibility and efficacy potential of the Heel2Toe sensor in improving gait in people with Parkinson\'s was supported.
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  • 文章类型: Journal Article
    背景:鉴于设施之间的地理距离和资源差异,在蒙大拿州,设施间的患者转移充满了诸如错过或无效的沟通等问题。不准确,缺席,或延迟患者详细信息可能会对患者结果产生负面影响,并进一步导致重复测试和用药错误。目的:本研究的目的是描述蒙大拿州执业护士在设施间转移过程中患者信息交流的过程。方法:研究设计是一种试点的横断面描述性方法。在线Qualtrics调查包括人口统计问题,两个探索性沟通能力工具,和四个开放式的问题,关于沟通间设备转移患者信息。结果:共有33名护士完成研究,大多数在危重症医院执业(n=15,47%)。沟通能力意味着分数随着二元对话而增加,缺乏标准化的切换工具被认为是一个挑战。护士认为以下是设施间转移交接中的障碍:不礼貌,大量的文书工作,互操作性问题,不完整或过时的信息,时间,和资源。对实践的影响:当前的交流实践存在很大的可变性,从口头到电子文件传输。农村医疗保健领域是继续围绕工作流程优化进行检查的首选,准确度,以及设施间转移时共享信息交换的一致性。有机会进行潜在的培训和教育,围绕有效的沟通,支持跨组织互动的人际交往行为,以及为设施间转移患者开发标准化的移交工具上下文。
    Background: Interfacility patient transfers are fraught with issues such as missed or ineffective communication in Montana given wide geographic distance between facilities and variance in resources. Inaccurate, absent, or delayed patient details may negatively affect patient outcomes and further result in duplicative testing and medication errors. Objective: The objective of this study was to describe the process of patient information communication during interfacility transfers as perceived by nurses practicing in Montana. Methods: The study design was a pilot cross-sectional descriptive approach. An online Qualtrics survey included demographic questions, two exploratory communication competence instruments, and four open-ended questions regarding communicating interfacility transfer patient information. Results: A total of 33 nurses completed the study, with the majority practicing at a critical access hospital (n = 15, 47%). Communication competence mean scores increased with dyad conversations, and a lack of standardized handoff tools was noted as a challenge. Nurses identified the following as barriers in the interfacility transfer handoff: incivility, amount of paperwork, interoperability issues, incomplete or outdated information, time, and resources. Implications for Practice: There is wide variability in current communication practices, ranging from verbal to electronic document transfers. The rural healthcare space is prime to continue examinations surrounding workflow optimization, accuracy, and consistency in shared information exchange at the time of interfacility transfer. There is an opportunity for potential training and education surrounding effective communication, interpersonal behaviors that support cross-organizational interactions, and the development of a standardized handoff tool contextual for interfacility transfer patients.
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  • 文章类型: Journal Article
    姑息治疗领域正在经历基于临床试验的研究的实质性增长。随机对照试验提供了必要的严密性和条件,以评估在受控人群中的治疗效果。因此,重要的是,从一开始就精心设计审判,以确保最终结果的完整性。在这篇文章中,我们的团队讨论了从该领域的集体经验中得出的关于临床试验设计的十条技巧.这十个技巧涵盖了一系列在试验设计中具有挑战性的主题,从开发初始方法到规划样本量和为试验提供动力,以及作为一个有凝聚力的团队协作指导试验启动和实施的伦理问题。我们的目标是帮助新的研究人员设计合理的试验,并继续扩大我们专业的证据基础。这里提供的指导可以独立使用,也可以与该团队在另一篇文章中提供的十个提示一起使用,该文章专注于姑息治疗临床医生在解释临床试验时应该知道的内容。
    The palliative care field is experiencing substantive growth in clinical trial-based research. Randomized controlled trials provide the necessary rigor and conditions for assessing a treatment\'s efficacy in a controlled population. It is therefore important that a trial is meticulously designed from the outset to ensure the integrity of the ultimate results. In this article, our team discusses ten tips on clinical trial design drawn from collective experiences in the field. These ten tips cover a range of topics that can prove challenging in trial design, from developing initial methodologies to planning sample size and powering the trial, as well as collaboratively navigating the ethical issues of trial initiation and implementation as a cohesive team. We aim to help new researchers design sound trials and continue to grow the evidence base for our specialty. The guidance provided here can be used independently or in addition to the ten tips provided by this team in a separate article focused on what palliative care clinicians should know about interpreting a clinical trial.
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  • 文章类型: Journal Article
    疤痕会导致美学或功能紊乱。已经描述了几种干预措施来改善它们的外观。我们建议这些治疗方法的组合可以协同它们对疤痕的影响。我们设计了一项前瞻性试点研究,使用10名患者作为自己的对照,以比较不同的干预措施。在每个病人中,疤痕分为四个不同的部分:1.无治疗(对照),2.只有脂肪移植,3.脂肪移植和透明质酸(HA),4.脂肪移植,HA和非分数激光。通过患者和观察者疤痕评估量表(POSAS)评估疤痕的每个部分。三种方式的组合治疗疤痕在观察者量表中显示出更好的结果。此外,脂肪注射的组合,HA,随后用非消融性激光进行皮肤表面置换,对观察者量表上的所有参数显示出更好的结果,除了血管分布,在患者量表厚度上,救济,柔韧性,表面积,总体测量情况较好。所有三种治疗的组合倾向于改善瘢痕形成结果并且看起来是安全和有效的。然而,需要对更大样本进行进一步研究,以探索这种联合治疗的潜在用途.
    Scars can cause aesthetic or functional disturbance. Several interventions had been described to improve their appearance. We propose that the combination of some of those treatments can synergize their effects on the scar. We designed a prospective pilot study with ten patients using the patient as their own control to compare different interventions. In each patient, the scar was divided into four parts treated differently: 1. No treatment (control), 2. Fat grafting only, 3. Fat grafting and Hyaluronic Acid (HA), 4. Fat grafting, HA and with a non-fractional laser. Each part of the scar was evaluated by the Patient and Observer Scar Assessment Scale (POSAS). Treatment of the scar with the combination of the three modalities showed better results in the observer scale. In addition, a combination of fat injection, HA, and subsequent skin resurfacing with non-ablative laser showed better outcomes for all parameters on the Observer Scale except vascularity, while on the Patient Scale thickness, relief, pliability, surface area, and overall measurement were better. The combination of all three treatments tends to improve scarring results and appears to be safe and effective. However, further studies with larger samples are needed to explore the potential use of this combined treatment.
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